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CompletedNCT03928821Updated Jul 11, 2022Results posted

Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants

A Phase 1 interventional study of PGT121 and PGDM1400 in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 4 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adults.

Read the detailed description

This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adults.

Participants will initially be enrolled into one of three groups. At Day 0, Groups 1, 2, and 3 will receive dual combinations of mAbs administered sequentially via IV. Group 1 will receive a combination of PGT121 and VRC07-523LS, Group 2 will receive PGDM1400 and VRC07-523LS, and Group 3 will receive 10-1074 and VRC07-523LS.

Study staff will review study data from Groups 1, 2, and 3 and determine if Group 4 may begin to enroll. Participants in Group 4 will receive PGDM1400, PGT121, and VRC07-523LS administered in sequence via IV on Day 0 and at Month 4.

Study duration will be 12 months for participants in Groups 1, 2, and 3, and 16 months for participants in Group 4. Participants will attend several study visits, which may include physical examinations, blood and urine collection, HIV testing and pretest counseling, risk reduction counseling, and questionnaires.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 27 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

General and Demographic Criteria

  • Age of 18 to 50 years
  • Access to a participating clinical research site (CRS) and willingness to be followed for the planned duration of the study
  • Ability and willingness to provide informed consent
  • Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly
  • Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit
  • Good general health as shown by medical history, physical exam, and screening laboratory tests

HIV-Related Criteria:

  • Willingness to receive HIV test results
  • Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
  • Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see the protocol for more information)

Laboratory Inclusion Values

Hemogram/Complete Blood Count

  • Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on feminizing hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
  • White blood cell count equal to 2,500 to 12,000 cells/mm\^3
  • White blood cell (WBC) differential either within institutional normal range or with site clinician approval
  • Platelets equal to 125,000 to 550,000/mm\^3

Chemistry

  • Chemistry panel: Alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal

Virology

  • Negative HIV-1 and -2 blood test: US volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
  • Negative Hepatitis B surface antigen (HBsAg)
  • Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive

Urine

  • Negative or trace urine protein

Reproductive Status

  • Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to study product administration on the day of initial study product administration. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.

  • Reproductive status: A volunteer who was assigned female sex at birth must:

    • Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using one of the following methods:
    • Condoms (male or female) with or without a spermicide,
    • Diaphragm or cervical cap with spermicide,
    • Intrauterine device (IUD),
    • Hormonal contraception,
    • Tubal ligation,
    • Any other contraceptive method approved by the HVTN 130/HPTN 089 Protocol Safety Review Team (PSRT)
    • Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
    • Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy or bilateral oophorectomy;
    • Or be sexually abstinent.
  • Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit.

Exclusion criteria

Exclusion Criteria:

General

  • Weight greater than 115 kg
  • Blood products received within 120 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 130/HPTN 089 PSRT
  • Investigational research agents received within 30 days before first study product administration
  • Intent to participate in another study of an investigational research agent or any other study that requires non-Network HIV antibody testing during the planned duration of the HVTN 130/HPTN 089 study
  • Pregnant or breastfeeding

Vaccines and other Injections

  • HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 130/HPTN 089 PSRT will determine eligibility on a case-by-case basis.
  • Previous receipt of humanized or human mAbs, whether licensed or investigational; the HVTN 130/HPTN 089 PSRT will determine eligibility on a case-by-case basis.
  • Previous receipt of monoclonal antibodies VRC01, VRC01LS, VRC07-523LS, PGT121, PGDM1400, or 10-1074

Immune System

  • Immunosuppressive medications received within 30 days before first study product administration (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatological condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than 20 mg/day and length of therapy less than 14 days.)
  • Serious adverse reactions to VRC07-523LS, PGT121, PGDM1400, or 10-1074 formulation components (acetate, sucrose, polysorbate 80, histidine, and sorbitol; see the protocol for more information), including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain
  • Immunoglobulin received within 90 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 130/HPTN 089 PSRT (for mAb see criterion above)
  • Autoimmune disease (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited AE assessments)
  • Immunodeficiency

Clinically significant medical conditions

  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:

    • A process that would affect the immune response,
    • A process that would require medication that affects the immune response,
    • Any contraindication to repeated infusions, or blood draws, including inability to establish venous or sub-cutaneous access.
    • A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
    • A condition or process (eg, chronic urticaria or recent injection or infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or
    • Any condition specifically listed among the exclusion criteria.
  • Any medical, psychiatric, occupational, or skin condition (eg, tattoos) that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, Solicited AEs, or a volunteer's ability to give informed consent
  • Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
  • Current anti-tuberculosis (TB) therapy

  • Asthma other than mild, well-controlled asthma (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:

    • Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
    • Uses moderate/high-dose, inhaled corticosteroids, or
    • In the past year has had either of the following:
    • Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
    • Needed emergency care, urgent care, hospitalization, or intubation for asthma.
  • Diabetes mellitus type 1 or type 2 (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes)

  • Hypertension:

    • If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
    • If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
  • Bleeding disorder diagnosed by a clinician (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study.)
  • Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
  • Asplenia: any condition resulting in the absence of a functional spleen
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Group 1: PGT121 + VRC07-523LS

    Participants will receive PGT121 and VRC07-523LS administered sequentially in this order at Day 0.

    Biological: PGT121 · Biological: VRC07-523LS

  • Experimental
    Group 2: PGDM1400 + VRC07-523LS

    Participants will receive PGDM1400 and VRC07-523LS administered sequentially in this order at Day 0.

    Biological: PGDM1400 · Biological: VRC07-523LS

  • Experimental
    Group 3: 10-1074 + VRC07-523LS

    Participants will receive 10-1074 and VRC07-523LS administered sequentially in this order at Day 0.

    Biological: 10-1074 · Biological: VRC07-523LS

  • Experimental
    Group 4: PGDM1400 + PGT121 + VRC07-523LS

    Participants will receive PGDM1400, PGT121, and VRC07-523LS administered sequentially in this order at Day 0 and Month 4.

    Biological: PGT121 · Biological: PGDM1400 · Biological: VRC07-523LS

Interventions

  • BiologicalPGT121

    20 mg/kg administered intravenously

  • BiologicalPGDM1400

    20 mg/kg administered intravenously

  • Biological10-1074

    20 mg/kg administered intravenously

  • BiologicalVRC07-523LS

    20 mg/kg administered intravenously

06

What researchers measure

Primary outcomes

  1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.

    Time frame: Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112

  2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.

    Time frame: Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112

  3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.

    Time frame: Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112

  4. Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Time frame: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4

  5. Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Time frame: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4

  6. Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Time frame: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4

  7. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Time frame: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4

  8. Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm

    For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

    Time frame: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4

  9. The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm

    The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm

    Time frame: Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, 448*, and 504* Days with * are only available for T4

  10. Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation

    The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm. The three participants discontinued treatment in T4 were due to the COVID-19 pandemic lockdown.

    Time frame: Measured through Month 4

Secondary outcomes

  1. Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations

    Serum PGDM1400, PGT121, and VRC07-523LS IgG levels were measured on a Bio-Plex instrument (Bio-Rad) using a validated assay designed to simultaneously measure infused PGDM1400, PGT121, and VRC07-523LS by its ability to bind anti-idiotype antibody captured on fluorescent magnetic beads. This assay was derived from a standardized custom HIV-1 Luminex assay. PGDM1400, PGT121 and VRC07-523LS were titrated and combined to create a standard curve that was used to determine concentration of the diluted samples. The negative controls were CH58 (an irrelevant mAb) and blank beads.Serum 10-1074 level was measured by anti-idotypic ELISA. Participant serum sample was incubated in anti-ID coated micro-plate well. A conjugated secondary antibody was used to detect bound 10-1074. Samples were titrated to ensure positive optical density (O.D.) readouts fall within the linear range of the assay for monoclonal antibody concentration calculations.

    Time frame: Measured during Screening, Days 0, 3, 6, 14, 28, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448* Days with * are only available for T4

  2. Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations

    Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.

    Time frame: Measured during Screening, Days 0, 3, 28, 56, 112, 140*, 168*, 224* Days with * are only available for T4

  3. Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants

    Serum PGDM1400, PGT121, and VRC07-523LS IgG levels were measured on a Bio-Plex instrument (Bio-Rad) using a validated assay designed to simultaneously measure infused PGDM1400, PGT121, and VRC07-523LS by its ability to bind anti-idiotype antibody captured on fluorescent magnetic beads. This assay was derived from a standardized custom HIV-1 Luminex assay. PGDM1400, PGT121 and VRC07-523LS were titrated and combined to create a standard curve that was used to determine concentration of the diluted samples. The negative controls were CH58 (an irrelevant mAb) and blank beads.Serum 10-1074 level was measured by anti-idotypic ELISA. Participant serum sample was incubated in anti-ID coated micro-plate well. A conjugated secondary antibody was used to detect bound 10-1074. Samples were titrated to ensure positive optical density (O.D.) readouts fall within the linear range of the assay for monoclonal antibody concentration calculations

    Time frame: Measured during Screening, Days 0, 3, 6, 14, 28, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448* Days with * are only available for T4

  4. Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants

    Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.

    Time frame: Measured during Screening, Days 0, 3, 28, 56, 112, 140*, 168*, 224* Days with * are only available for T4

  5. Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants

    Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.

    Time frame: Measured during Screening, Days 0*, 3, 28, 56*, 112, 140*, 224* Days with * are only available for T4

07

Results

Posted Jul 11, 2022

Participant flow

Participant flow — Overall Study
MilestoneT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Started6669
Completed6338
Not completed0331
Withdrew: Death0100
Withdrew: Lost to follow-up0230
Withdrew: Participant unable to adhere to visit schedule0001

Outcome measures

PrimaryNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.

Time frame:
Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112
Reported as:
Count of participants · Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
ParticipantsT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
None5667
Mild1002
Moderate0000
Severe0000
Potentially life-threatening0000
PrimaryNumber of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.

Time frame:
Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112
Reported as:
Count of participants · Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
ParticipantsT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Erythema/redness — None6669
Erythema/redness — Not Gradable0000
Erythema/redness — Gr 1: 2.5 to less than 5 cm dim.0000
Erythema/redness — Gr 2: 5 to less than 10 cm dim.0000
Erythema/redness — Gr 3: >=10 cm dim.0000
Erythema/redness — Gr 3: Complications AE0000
Erythema/redness — Gr 4: Complications AE0000
Induration/swelling — None5669
Induration/swelling — Not Gradable1000
Induration/swelling — Gr 1: 2.5 to less than 5 cm dim.0000
Induration/swelling — Gr 2: 5 to less than 10 cm dim.0000
Induration/swelling — Gr 3: >=10 cm dim.0000
Induration/swelling — Gr 3: Complications AE0000
Induration/swelling — Gr 4: Complications AE0000
Erythema and/or Induration — None5669
Erythema and/or Induration — Not Gradable1000
Erythema and/or Induration — Gr 1: 2.5 to less than 5 cm dim.0000
Erythema and/or Induration — Gr 2: 5 to less than 10 cm dim.0000
Erythema and/or Induration — Gr 3: >=10 cm dim.0000
Erythema and/or Induration — Gr 3: Complications AE0000
Erythema and/or Induration — Gr 4: Complications AE0000
PrimaryNumber of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.

Time frame:
Measured through 3 days after each vaccine dose at T1-T3: Day 0 and T4: Days 0, 112
Reported as:
Count of participants · Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
ParticipantsT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Arthralgia — None5559
Arthralgia — Mild1110
Arthralgia — Moderate0000
Arthralgia — Severe0000
Arthralgia — Potentially life-threatening0000
Chills — None6467
Chills — Mild0102
Chills — Moderate0100
Chills — Severe0000
Chills — Potentially life-threatening0000
Facial flushing — None6569
Facial flushing — Mild0100
Facial flushing — Moderate0000
Facial flushing — Severe0000
Facial flushing — Potentially life-threatening0000
Generalized pruritus — None6659
Generalized pruritus — Mild0010
Generalized pruritus — Moderate0000
Generalized pruritus — Severe0000
Generalized pruritus — Potentially life-threatening0000
Headache — None3459
Headache — Mild3210
Headache — Moderate0000
Headache — Severe0000
Headache — Potentially life-threatening0000
Increased body temperature — None6669
Increased body temperature — Mild0000
Increased body temperature — Moderate0000
Increased body temperature — Severe0000
Increased body temperature — Potentially life-threatening0000
Malaise and/or fatigue — None5243
Malaise and/or fatigue — Mild1315
Malaise and/or fatigue — Moderate0111
Malaise and/or fatigue — Severe0000
Malaise and/or fatigue — Potentially life-threatening0000
Myalgia — None5567
Myalgia — Mild0102
Myalgia — Moderate1000
Myalgia — Severe0000
Myalgia — Potentially life-threatening0000
Nausea — None6549
Nausea — Mild0120
Nausea — Moderate0000
Nausea — Severe0000
Nausea — Potentially life-threatening0000
Non-exertional dyspnea — None6669
Non-exertional dyspnea — Mild0000
Non-exertional dyspnea — Moderate0000
Non-exertional dyspnea — Severe0000
Non-exertional dyspnea — Potentially life-threatening0000
Non-exertional tachycardia — None6669
Non-exertional tachycardia — Mild0000
Non-exertional tachycardia — Moderate0000
Non-exertional tachycardia — Severe0000
Non-exertional tachycardia — Potentially life-threatening0000
Unexplained diaphoresis — None6669
Unexplained diaphoresis — Mild0000
Unexplained diaphoresis — Moderate0000
Unexplained diaphoresis — Severe0000
Unexplained diaphoresis — Potentially life-threatening0000
Urticaria — None6669
Urticaria — Mild0000
Urticaria — Moderate0000
Urticaria — Severe0000
Urticaria — Potentially life-threatening0000
Max. Systemic Symptoms — None3123
Max. Systemic Symptoms — Mild2335
Max. Systemic Symptoms — Moderate1211
Max. Systemic Symptoms — Severe0000
Max. Systemic Symptoms — Potentially life-threatening0000
Temperature (C) — None6669
Temperature (C) — Mild0000
Temperature (C) — Moderate0000
Temperature (C) — Severe0000
Temperature (C) — Potentially life-threatening0000
PrimaryChemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame:
Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4
Reported as:
Median · U/L
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
U/LT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Alanine Aminotransferase (U/L)-Baseline15 (14 to 20)14 (12 to 15)13 (10 to 17)14 (12 to 15)
Alanine Aminotransferase (U/L)-Day 014 (8 to 17)12 (10 to 17)13 (10 to 16)14 (10 to 16)
Alanine Aminotransferase (U/L)-Day 1414 (13 to 15)16 (11 to 21)11 (10 to 12)12 (10 to 16)
Alanine Aminotransferase (U/L)-Day 5613 (9 to 19)15 (11 to 21)20 (12 to 21)16 (13 to 17)
Alanine Aminotransferase (U/L)-Day 84———13 (12 to 15)
Alanine Aminotransferase (U/L)-Day 11217 (8 to 23)9 (9 to 27)16 (14 to 17)15 (11 to 15)
Alanine Aminotransferase (U/L)-Day 140———18 (9 to 20)
Alanine Aminotransferase (U/L)-Day 16814 (8 to 24)11 (10 to 16)17 (16 to 18)17 (17 to 17)
Alanine Aminotransferase (U/L)-Day 22424 (24 to 24)12 (12 to 12)—14 (10 to 15)
Alanine Aminotransferase (U/L)-Day 280—12 (12 to 12)13 (11 to 27)14 (10 to 17)
Alanine Aminotransferase (U/L)-Day 33618 (15 to 22)8 (7 to 9)14 (13 to 23)16 (11 to 19)
Alanine Aminotransferase (U/L)-Day 392———15 (13 to 18)
Alanine Aminotransferase (U/L)-Day 448———14 (11 to 18)
PrimaryChemistry and Hematology Laboratory Measures - Creatinine in mg/dL

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame:
Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4
Reported as:
Median · mg/dL
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
mg/dLT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Creatinine (mg/dL)-Baseline1 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 01 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 141 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 561 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 84———1 (1 to 1)
Creatinine (mg/dL)-Day 1121 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 140———1 (1 to 1)
Creatinine (mg/dL)-Day 1681 (1 to 1)1 (0 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 2241 (1 to 1)1 (1 to 1)—1 (1 to 1)
Creatinine (mg/dL)-Day 280—1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 3361 (1 to 1)1 (1 to 1)1 (1 to 1)1 (1 to 1)
Creatinine (mg/dL)-Day 392———1 (1 to 1)
Creatinine (mg/dL)-Day 448———1 (1 to 1)
PrimaryChemistry and Hematology Laboratory Measures - Hemoglobin in g/dL

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame:
Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4
Reported as:
Median · g/dL
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
g/dLT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Hemoglobin (g/dL)-Baseline14 (13 to 15)14 (13 to 14)15 (11 to 15)14 (13 to 14)
Hemoglobin (g/dL)-Day 013 (12 to 15)13 (13 to 14)13 (11 to 15)14 (13 to 14)
Hemoglobin (g/dL)-Day 1413 (12 to 14)14 (13 to 15)13 (11 to 14)14 (12 to 15)
Hemoglobin (g/dL)-Day 5613 (12 to 14)14 (13 to 15)14 (11 to 14)14 (13 to 15)
Hemoglobin (g/dL)-Day 84———15 (13 to 15)
Hemoglobin (g/dL)-Day 11213 (13 to 15)13 (13 to 15)14 (11 to 14)13 (12 to 14)
Hemoglobin (g/dL)-Day 140———14 (13 to 14)
Hemoglobin (g/dL)-Day 16813 (13 to 13)13 (13 to 14)14 (13 to 15)14 (14 to 14)
Hemoglobin (g/dL)-Day 22413 (13 to 13)13 (13 to 13)—14 (12 to 15)
Hemoglobin (g/dL)-Day 280—13 (13 to 13)12 (11 to 14)14 (13 to 14)
Hemoglobin (g/dL)-Day 33613 (13 to 14)13 (12 to 14)13 (11 to 14)14 (13 to 15)
Hemoglobin (g/dL)-Day 392———14 (13 to 15)
Hemoglobin (g/dL)-Day 448———14 (13 to 15)
PrimaryChemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame:
Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4
Reported as:
Median · 1000 cells/cubic mm
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
1000 cells/cubic mmT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Lymphocytes (1000 cells/cubic mm)-Baseline1.65 (1.33 to 2.13)2.191 (1.67 to 2.46)1.551 (0.89 to 1.946)2.31 (1.48 to 2.605)
Lymphocytes (1000 cells/cubic mm)-Day 01.778 (1.13 to 2.18)1.785 (1.618 to 2.2)1.445 (1.32 to 1.612)1.802 (1.68 to 2.17)
Lymphocytes (1000 cells/cubic mm)-Day 141.63 (1.3 to 1.719)1.781 (1.528 to 1.95)1.54 (1.385 to 2.279)1.99 (1.58 to 2.69)
Lymphocytes (1000 cells/cubic mm)-Day 561.824 (1.375 to 1.982)1.667 (1.59 to 1.84)1.723 (1.36 to 2.033)2.176 (1.72 to 2.24)
Lymphocytes (1000 cells/cubic mm)-Day 84———1.83 (1.761 to 2.27)
Lymphocytes (1000 cells/cubic mm)-Day 1121.693 (1.2 to 2.255)1.768 (1.529 to 1.9)1.22 (1.21 to 2.048)2.002 (1.55 to 2.14)
Lymphocytes (1000 cells/cubic mm)-Day 140———1.487 (1.4 to 1.67)
Lymphocytes (1000 cells/cubic mm)-Day 1681.688 (1.465 to 2.009)2.015 (1.97 to 2.42)1.918 (1.405 to 2.195)1.65 (1.64 to 1.66)
Lymphocytes (1000 cells/cubic mm)-Day 2241.02 (1.02 to 1.02)2.9 (2.9 to 2.9)—2.015 (1.5 to 2.16)
Lymphocytes (1000 cells/cubic mm)-Day 280—2.14 (2.14 to 2.14)1.563 (1.32 to 1.93)1.74 (1.49 to 2.22)
Lymphocytes (1000 cells/cubic mm)-Day 3361.651 (1.26 to 1.762)1.764 (1.72 to 1.807)1.927 (1.288 to 2.035)1.898 (1.675 to 2.1)
Lymphocytes (1000 cells/cubic mm)-Day 392———1.849 (1.74 to 2.15)
Lymphocytes (1000 cells/cubic mm)-Day 448———1.76 (1.57 to 2)
Neutrophils (1000 cells/cubic mm)-Baseline3.338 (3.072 to 4.602)3.56 (3.227 to 3.71)3.39 (2.46 to 3.962)4.194 (2.97 to 5.97)
Neutrophils (1000 cells/cubic mm)-Day 03.307 (2.616 to 3.91)3.032 (2.5 to 3.856)2.962 (2.88 to 4.8)4.3 (3.42 to 5.32)
Neutrophils (1000 cells/cubic mm)-Day 143.181 (2.573 to 3.382)4.037 (3.71 to 4.395)4.024 (3.135 to 4.73)4.831 (3.7 to 5.05)
Neutrophils (1000 cells/cubic mm)-Day 562.762 (2.655 to 3.36)3.581 (2.67 to 4.68)3.55 (3.235 to 4.082)4.98 (4.07 to 5.624)
Neutrophils (1000 cells/cubic mm)-Day 84———4.12 (3.22 to 5.48)
Neutrophils (1000 cells/cubic mm)-Day 1123.377 (2.654 to 3.714)3.22 (2.86 to 3.98)2.944 (2.39 to 3.66)3.735 (2.42 to 4.181)
Neutrophils (1000 cells/cubic mm)-Day 140———4.108 (2.45 to 4.47)
Neutrophils (1000 cells/cubic mm)-Day 1683.882 (3.524 to 4.208)4.285 (2.31 to 6.16)3.272 (2.662 to 3.479)3.155 (2.63 to 3.68)
Neutrophils (1000 cells/cubic mm)-Day 2245.24 (5.24 to 5.24)3.38 (3.38 to 3.38)—2.855 (2.73 to 4.77)
Neutrophils (1000 cells/cubic mm)-Day 280—3.35 (3.35 to 3.35)3.922 (3.112 to 4.357)4.14 (2.02 to 5.257)
Neutrophils (1000 cells/cubic mm)-Day 3363.93 (2.672 to 3.994)2.858 (2.72 to 2.995)2.315 (1.9 to 4.752)3 (2.88 to 4.868)
Neutrophils (1000 cells/cubic mm)-Day 392———3.565 (2.68 to 5.25)
Neutrophils (1000 cells/cubic mm)-Day 448———3.81 (2.99 to 5.491)
PrimaryChemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm

For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.

Time frame:
Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448*. Days with * are only available for T4
Reported as:
Median · 1000 cells/cubic mm
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
1000 cells/cubic mmT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
WBC (1000 cells/cubic mm)-Baseline6.25 (5.5 to 7.54)6.615 (5.4 to 6.9)5.6 (4.63 to 6.4)6.1 (5.9 to 9.61)
WBC (1000 cells/cubic mm)-Day 06.145 (5.2 to 6.46)5.665 (5.33 to 6.8)5.4 (4.83 to 6.76)6.53 (6.3 to 8.2)
WBC (1000 cells/cubic mm)-Day 145.55 (4.9 to 6.34)6.645 (5.8 to 6.8)6.27 (5.5 to 6.87)7.49 (5.9 to 7.7)
WBC (1000 cells/cubic mm)-Day 565.25 (5.1 to 6.5)5.985 (5.7 to 7.29)5.6 (5.47 to 6.5)7.8 (7.6 to 8.6)
WBC (1000 cells/cubic mm)-Day 84———6.5 (6.3 to 8)
WBC (1000 cells/cubic mm)-Day 1125.85 (5.4 to 6.78)6.4 (5.2 to 6.76)4.9 (4.6 to 6.87)6.15 (5.26 to 6.9)
WBC (1000 cells/cubic mm)-Day 140———6.3 (4.3 to 6.7)
WBC (1000 cells/cubic mm)-Day 1686.29 (6.19 to 6.42)6.9 (5.77 to 9.15)5.35 (5.15 to 5.78)5.35 (4.8 to 5.9)
WBC (1000 cells/cubic mm)-Day 2246.93 (6.93 to 6.93)7.07 (7.07 to 7.07)—5.6 (4.8 to 7.5)
WBC (1000 cells/cubic mm)-Day 280—6.24 (6.24 to 6.24)5.9 (5.37 to 6.515)6.2 (4.2 to 8.1)
WBC (1000 cells/cubic mm)-Day 3365.9 (4.6 to 6.4)5.18 (5.06 to 5.3)5.1 (3.8 to 7.3)5.76 (5.25 to 7.4)
WBC (1000 cells/cubic mm)-Day 392———6.25 (5.6 to 7)
WBC (1000 cells/cubic mm)-Day 448———6.2 (5.2 to 7.5)
Platelets (1000 cells/cubic mm)-Baseline219.5 (200 to 259)303 (265 to 346)245.5 (158 to 299)248 (209 to 269)
Platelets (1000 cells/cubic mm)-Day 0217 (193 to 245)317 (244 to 328)241.5 (156 to 292)267 (246 to 274)
Platelets (1000 cells/cubic mm)-Day 14218.5 (189 to 242)291 (228 to 338)244.5 (168 to 314)250 (241 to 296)
Platelets (1000 cells/cubic mm)-Day 56228.5 (198 to 242)327.5 (258 to 346)278 (189 to 346)288 (244 to 302)
Platelets (1000 cells/cubic mm)-Day 84———259 (250 to 281)
Platelets (1000 cells/cubic mm)-Day 112221.5 (205 to 247)349 (272 to 377)259 (204 to 297)243 (214 to 297)
Platelets (1000 cells/cubic mm)-Day 140———195 (174 to 289)
Platelets (1000 cells/cubic mm)-Day 168208 (155.5 to 248)380 (265 to 403)239 (176 to 301.5)159 (127 to 191)
Platelets (1000 cells/cubic mm)-Day 224158 (158 to 158)336 (336 to 336)—250.5 (227 to 264)
Platelets (1000 cells/cubic mm)-Day 280—361 (361 to 361)218 (134 to 293)254 (234 to 279)
Platelets (1000 cells/cubic mm)-Day 336233 (189 to 258.5)373.5 (373 to 374)249 (129 to 314)242 (234.5 to 267)
Platelets (1000 cells/cubic mm)-Day 392———264.5 (212 to 288)
Platelets (1000 cells/cubic mm)-Day 448———246 (227 to 296)
PrimaryThe Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm

The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm

Time frame:
Measured during Screening, Days 0, 14, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, 448*, and 504* Days with * are only available for T4
Reported as:
Count of participants · Participants
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
ParticipantsT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Alanine Aminotransferase (U/L)-Baseline0000
Alanine Aminotransferase (U/L)-Day 00000
Alanine Aminotransferase (U/L)-Day 140000
Alanine Aminotransferase (U/L)-Day 560000
Alanine Aminotransferase (U/L)-Day 840000
Alanine Aminotransferase (U/L)-Day 1120000
Alanine Aminotransferase (U/L)-Day 1400000
Alanine Aminotransferase (U/L)-Day 1680000
Alanine Aminotransferase (U/L)-Day 2240000
Alanine Aminotransferase (U/L)-Day 2800000
Alanine Aminotransferase (U/L)-Day 3360000
Alanine Aminotransferase (U/L)-Day 3920000
Alanine Aminotransferase (U/L)-Day 4480000
Hemoglobin (g/dL)-Baseline0000
Hemoglobin (g/dL)-Day 00000
Hemoglobin (g/dL)-Day 140010
Hemoglobin (g/dL)-Day 560010
Hemoglobin (g/dL)-Day 840000
Hemoglobin (g/dL)-Day 1120000
Hemoglobin (g/dL)-Day 1400000
Hemoglobin (g/dL)-Day 1680000
Hemoglobin (g/dL)-Day 2240000
Hemoglobin (g/dL)-Day 2800000
Hemoglobin (g/dL)-Day 3360000
Hemoglobin (g/dL)-Day 3920000
Hemoglobin (g/dL)-Day 4480000
Creatinine (mg/dL)-Baseline0000
Creatinine (mg/dL)-Day 00000
Creatinine (mg/dL)-Day 140000
Creatinine (mg/dL)-Day 560000
Creatinine (mg/dL)-Day 840000
Creatinine (mg/dL)-Day 1120000
Creatinine (mg/dL)-Day 1400000
Creatinine (mg/dL)-Day 1680000
Creatinine (mg/dL)-Day 2240000
Creatinine (mg/dL)-Day 2800000
Creatinine (mg/dL)-Day 3360000
Creatinine (mg/dL)-Day 3920000
Creatinine (mg/dL)-Day 4480000
WBC (1000 cells/cubic mm)-Baseline0000
WBC (1000 cells/cubic mm)-Day 00000
WBC (1000 cells/cubic mm)-Day 140000
WBC (1000 cells/cubic mm)-Day 560000
WBC (1000 cells/cubic mm)-Day 840000
WBC (1000 cells/cubic mm)-Day 1120000
WBC (1000 cells/cubic mm)-Day 1400000
WBC (1000 cells/cubic mm)-Day 1680000
WBC (1000 cells/cubic mm)-Day 2240000
WBC (1000 cells/cubic mm)-Day 2800000
WBC (1000 cells/cubic mm)-Day 3360000
WBC (1000 cells/cubic mm)-Day 3920000
WBC (1000 cells/cubic mm)-Day 4480000
Platelets (1000 cells/cubic mm)-Baseline0000
Platelets (1000 cells/cubic mm)-Day 00000
Platelets (1000 cells/cubic mm)-Day 140010
Platelets (1000 cells/cubic mm)-Day 561001
Platelets (1000 cells/cubic mm)-Day 840000
Platelets (1000 cells/cubic mm)-Day 1122000
Platelets (1000 cells/cubic mm)-Day 1400000
Platelets (1000 cells/cubic mm)-Day 1681000
Platelets (1000 cells/cubic mm)-Day 2240000
Platelets (1000 cells/cubic mm)-Day 2800010
Platelets (1000 cells/cubic mm)-Day 3360001
Platelets (1000 cells/cubic mm)-Day 3920000
Platelets (1000 cells/cubic mm)-Day 4480000
Lymphocytes (1000 cells/cubic mm)-Baseline0000
Lymphocytes (1000 cells/cubic mm)-Day 00000
Lymphocytes (1000 cells/cubic mm)-Day 140002
Lymphocytes (1000 cells/cubic mm)-Day 560000
Lymphocytes (1000 cells/cubic mm)-Day 840000
Lymphocytes (1000 cells/cubic mm)-Day 1120000
Lymphocytes (1000 cells/cubic mm)-Day 1400000
Lymphocytes (1000 cells/cubic mm)-Day 1680000
Lymphocytes (1000 cells/cubic mm)-Day 2240000
Lymphocytes (1000 cells/cubic mm)-Day 2800000
Lymphocytes (1000 cells/cubic mm)-Day 3360000
Lymphocytes (1000 cells/cubic mm)-Day 3920000
Lymphocytes (1000 cells/cubic mm)-Day 4480000
Neutrophils (1000 cells/cubic mm)-Baseline0000
Neutrophils (1000 cells/cubic mm)-Day 00000
Neutrophils (1000 cells/cubic mm)-Day 140000
Neutrophils (1000 cells/cubic mm)-Day 560000
Neutrophils (1000 cells/cubic mm)-Day 840000
Neutrophils (1000 cells/cubic mm)-Day 1120000
Neutrophils (1000 cells/cubic mm)-Day 1400000
Neutrophils (1000 cells/cubic mm)-Day 1680000
Neutrophils (1000 cells/cubic mm)-Day 2240000
Neutrophils (1000 cells/cubic mm)-Day 2800000
Neutrophils (1000 cells/cubic mm)-Day 3360000
Neutrophils (1000 cells/cubic mm)-Day 3920000
Neutrophils (1000 cells/cubic mm)-Day 4480000
PrimaryNumber of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation

The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm. The three participants discontinued treatment in T4 were due to the COVID-19 pandemic lockdown.

Time frame:
Measured through Month 4
Reported as:
Count of participants · Participants
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
ParticipantsT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Pregnancy0000
HIV infection0000
Death0000
Clinical event other than reactogenicity, HIV infection, or death0000
Solicited adverse event symptom0000
Investigator Reason0000
Participant refused SPA0000
Co-Enrollment in a study with an investigational research agent0000
Psychiatric reason0000
Participant unable to schedule visit within window0000
Unable to contact participant0000
Incarceration0000
Other0003
Did not Discontinue SPA6666
SecondarySerum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations

Serum PGDM1400, PGT121, and VRC07-523LS IgG levels were measured on a Bio-Plex instrument (Bio-Rad) using a validated assay designed to simultaneously measure infused PGDM1400, PGT121, and VRC07-523LS by its ability to bind anti-idiotype antibody captured on fluorescent magnetic beads. This assay was derived from a standardized custom HIV-1 Luminex assay. PGDM1400, PGT121 and VRC07-523LS were titrated and combined to create a standard curve that was used to determine concentration of the diluted samples. The negative controls were CH58 (an irrelevant mAb) and blank beads.Serum 10-1074 level was measured by anti-idotypic ELISA. Participant serum sample was incubated in anti-ID coated micro-plate well. A conjugated secondary antibody was used to detect bound 10-1074. Samples were titrated to ensure positive optical density (O.D.) readouts fall within the linear range of the assay for monoclonal antibody concentration calculations.

Time frame:
Measured during Screening, Days 0, 3, 6, 14, 28, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448* Days with * are only available for T4
Reported as:
Median · mg/ml
Serum Concentration Levels of PGT121, PGDM1400, and VRC07-523LS Among Participants Who Received All Scheduled Product Administrations
mg/mlT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
10-1074 (Day- 0)——0.21 (0.21 to 0.21)—
10-1074 (Day- 3)——598.55 (444.43 to 844.87)—
10-1074 (Day- 6)——453.99 (378.63 to 529.19)—
10-1074 (Day- 14)——300.15 (279.57 to 315.65)—
10-1074 (Day- 28)——242.22 (140.97 to 253.34)—
10-1074 (Day- 56)——111.62 (81.11 to 127.39)—
10-1074 (Day-112)——25.18 (19.22 to 32.51)—
10-1074 (Day-168)——8.60 (6.27 to 11.17)—
10-1074 (Day-280)——0.98 (0.59 to 3.25)—
10-1074 (Day-336)——2.44 (1.32 to 3.55)—
PGDM1400 (Day- 0)—0.02 (0.02 to 0.02)—0.02 (0.02 to 0.02)
PGDM1400 (Day- 3)—251.54 (234.47 to 273.48)—209.25 (191.70 to 315.97)
PGDM1400 (Day- 6)—182.23 (160.51 to 186.36)—172.18 (163.04 to 193.95)
PGDM1400 (Day- 14)—139.77 (134.94 to 146.76)—129.97 (116.59 to 143.36)
PGDM1400 (Day- 28)—70.92 (67.17 to 73.87)—67.59 (55.45 to 75.91)
PGDM1400 (Day- 56)—27.88 (26.68 to 31.56)—28.38 (18.02 to 39.50)
PGDM1400 (Day- 84)———10.93 (7.79 to 14.97)
PGDM1400 (Day-112)—5.50 (4.63 to 6.04)—4.99 (3.81 to 7.11)
PGDM1400 (Day-140)———46.07 (46.07 to 46.07)
PGDM1400 (Day-168)—1.08 (1.02 to 1.10)——
PGDM1400 (Day-224)—0.26 (0.26 to 0.26)—6.24 (4.22 to 9.12)
PGDM1400 (Day-280)—0.09 (0.09 to 0.09)—1.27 (0.50 to 1.55)
PGDM1400 (Day-336)—0.02 (0.02 to 0.02)—0.52 (0.18 to 0.67)
PGDM1400 (Day-392)———0.11 (0.04 to 0.12)
PGDM1400 (Day-448)———0.02 (0.02 to 0.04)
PGT121 (Day- 0)0.05 (0.05 to 0.05)——0.05 (0.05 to 0.05)
PGT121 (Day- 3)196.57 (172.85 to 210.31)——169.62 (153.15 to 218.39)
PGT121 (Day- 6)129.35 (116.95 to 137.34)——130.33 (128.40 to 139.89)
PGT121 (Day- 14)80.12 (79.07 to 86.22)——95.54 (90.48 to 101.27)
PGT121 (Day- 28)44.46 (40.81 to 50.03)——60.62 (54.15 to 68.21)
PGT121 (Day- 56)22.08 (18.83 to 23.24)——25.79 (16.64 to 30.72)
PGT121 (Day- 84)———12.42 (9.09 to 15.18)
PGT121 (Day-112)4.03 (3.45 to 5.97)——5.82 (5.60 to 10.02)
PGT121 (Day-140)———49.17 (49.17 to 49.17)
PGT121 (Day-168)1.70 (0.88 to 3.28)———
PGT121 (Day-224)0.31 (0.31 to 0.31)——11.28 (7.72 to 12.63)
PGT121 (Day-280)———2.36 (1.46 to 4.57)
PGT121 (Day-336)0.05 (0.05 to 0.11)——1.05 (0.56 to 2.06)
PGT121 (Day-392)———0.33 (0.17 to 0.65)
PGT121 (Day-448)———0.10 (0.05 to 0.29)
VRC07-523LS (Day- 0)0.01 (0.01 to 0.02)0.01 (0.01 to 0.01)0.01 (0.01 to 0.01)0.01 (0.01 to 0.01)
VRC07-523LS (Day- 3)265.97 (262.58 to 300.62)239.32 (224.13 to 264.34)182.66 (164.80 to 187.40)212.11 (195.83 to 306.56)
VRC07-523LS (Day- 6)171.02 (158.01 to 209.24)176.51 (158.50 to 183.85)176.01 (167.23 to 176.82)156.15 (154.76 to 175.84)
VRC07-523LS (Day- 14)134.44 (128.24 to 135.66)139.18 (105.71 to 155.86)119.67 (90.44 to 145.10)140.86 (123.89 to 162.85)
VRC07-523LS (Day- 28)94.58 (88.61 to 102.26)96.17 (83.80 to 110.65)87.91 (85.13 to 96.66)101.42 (97.05 to 107.31)
VRC07-523LS (Day- 56)60.53 (55.78 to 62.70)56.91 (56.03 to 58.35)59.33 (51.36 to 63.18)56.94 (42.61 to 63.36)
VRC07-523LS (Day- 84)———39.57 (28.79 to 45.09)
VRC07-523LS (Day-112)24.93 (20.69 to 26.88)31.65 (20.09 to 33.07)29.37 (24.02 to 30.69)26.07 (19.85 to 33.70)
VRC07-523LS (Day-140)———76.03 (76.03 to 76.03)
VRC07-523LS (Day-168)14.45 (12.37 to 16.66)12.57 (10.74 to 14.17)11.57 (9.73 to 12.35)—
VRC07-523LS (Day-224)8.47 (8.47 to 8.47)11.24 (11.24 to 11.24)—39.86 (31.26 to 42.29)
VRC07-523LS (Day-280)—3.88 (3.88 to 3.88)3.17 (1.81 to 3.50)15.13 (14.85 to 16.50)
VRC07-523LS (Day-336)1.33 (1.08 to 1.38)1.31 (1.16 to 1.46)1.48 (0.85 to 2.34)9.52 (6.85 to 10.98)
VRC07-523LS (Day-392)———4.49 (2.73 to 5.51)
VRC07-523LS (Day-448)———2.16 (1.10 to 2.59)
SecondaryMagnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations

Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.

Time frame:
Measured during Screening, Days 0, 3, 28, 56, 112, 140*, 168*, 224* Days with * are only available for T4
Reported as:
Median · Relative luminescence units (RLU)
Magnitudes of TZM-bl Cells Responses Against mAb-specific Env-pseudotyped Viruses Among Participants Who Received All Scheduled Product Administrations
Relative luminescence units (RLU)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
6540.v4.c1 (Day- 0)———5.00 (5.00 to 5.00)
6540.v4.c1 (Day- 3)———12301.30 (9796.41 to 17398.1)
6540.v4.c1 (Day- 28)———2365.28 (1930.73 to 2730.45)
6540.v4.c1 (Day- 56)———674.62 (512.44 to 784.11)
6540.v4.c1 (Day-112)———82.11 (61.03 to 98.13)
6540.v4.c1 (Day-140)———1255.62 (1255.62 to 1255.62)
6540.v4.c1 (Day-224)———64.76 (46.21 to 113.02)
CH505TF.N334S.N160A.N280D.1 (Day- 0)———5.00 (5.00 to 5.00)
CH505TF.N334S.N160A.N280D.1 (Day- 3)———13209.26 (9855.80 to 16397.4)
CH505TF.N334S.N160A.N280D.1 (Day- 28)———3344.91 (2579.95 to 3806.03)
CH505TF.N334S.N160A.N280D.1 (Day- 56)———1491.45 (901.81 to 1966.97)
CH505TF.N334S.N160A.N280D.1 (Day-112)———339.83 (296.59 to 554.03)
CH505TF.N334S.N160A.N280D.1 (Day-140)———2563.08 (2563.08 to 2563.08)
CH505TF.N334S.N160A.N280D.1 (Day-224)———429.44 (318.03 to 585.79)
CNE55.N160K (Day- 0)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)
CNE55.N160K (Day- 3)917.25 (686.59 to 1286.70)816.88 (725.91 to 847.67)493.12 (383.85 to 549.58)469.12 (432.41 to 868.21)
CNE55.N160K (Day- 28)259.58 (212.45 to 323.50)188.55 (161.50 to 208.80)206.12 (171.05 to 268.36)218.32 (169.74 to 257.46)
CNE55.N160K (Day- 56)105.02 (91.83 to 118.53)91.57 (80.40 to 117.12)170.55 (138.00 to 193.64)131.99 (106.91 to 149.44)
CNE55.N160K (Day-112)28.65 (25.10 to 36.11)10.00 (10.00 to 20.95)53.48 (38.18 to 59.63)47.57 (30.49 to 65.17)
CNE55.N160K (Day-140)———92.76 (92.76 to 92.76)
CNE55.N160K (Day-224)———58.52 (48.16 to 82.07)
T250-4 (Day- 0)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)—
T250-4 (Day- 3)32029.39 (28181.95 to 41032.5)91301.02 (79640.01 to 114904.)39113.31 (31644.98 to 45736.7)—
T250-4 (Day- 28)6458.16 (5518.54 to 7452.56)27318.99 (23401.71 to 30312.3)13028.85 (11586.88 to 14345.8)—
T250-4 (Day- 56)2016.84 (1800.34 to 2646.68)7523.58 (6020.17 to 8716.04)7070.48 (5359.84 to 7736.68)—
T250-4 (Day-112)300.37 (266.45 to 650.96)800.00 (618.17 to 837.77)1189.03 (760.30 to 1712.31)—
SecondarySerum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants

Serum PGDM1400, PGT121, and VRC07-523LS IgG levels were measured on a Bio-Plex instrument (Bio-Rad) using a validated assay designed to simultaneously measure infused PGDM1400, PGT121, and VRC07-523LS by its ability to bind anti-idiotype antibody captured on fluorescent magnetic beads. This assay was derived from a standardized custom HIV-1 Luminex assay. PGDM1400, PGT121 and VRC07-523LS were titrated and combined to create a standard curve that was used to determine concentration of the diluted samples. The negative controls were CH58 (an irrelevant mAb) and blank beads.Serum 10-1074 level was measured by anti-idotypic ELISA. Participant serum sample was incubated in anti-ID coated micro-plate well. A conjugated secondary antibody was used to detect bound 10-1074. Samples were titrated to ensure positive optical density (O.D.) readouts fall within the linear range of the assay for monoclonal antibody concentration calculations

Time frame:
Measured during Screening, Days 0, 3, 6, 14, 28, 56, 84*, 112, 140*, 168, 224, 280, 336, 392*, and 448* Days with * are only available for T4
Reported as:
Median · mg/ml
Serum Concentrations of PGT121, PGDM1400, 10-1074, and VRC07-523LS for All Participants
mg/mlT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
10-1074 (Day- 0)——0.21 (0.21 to 0.21)—
10-1074 (Day- 3)——521.49 (422.63 to 783.29)—
10-1074 (Day- 6)——416.31 (298.03 to 510.39)—
10-1074 (Day- 14)——289.86 (207.92 to 311.78)—
10-1074 (Day- 28)——242.22 (140.97 to 253.34)—
10-1074 (Day- 56)——98.27 (29.65 to 124.97)—
10-1074 (Day-112)——23.96 (8.04 to 26.39)—
10-1074 (Day-168)——8.60 (6.27 to 11.17)—
10-1074 (Day-280)——0.59 (0.21 to 2.11)—
10-1074 (Day-336)——2.44 (1.32 to 3.55)—
PGDM1400 (Day- 0)—0.02 (0.02 to 0.02)—0.02 (0.02 to 0.02)
PGDM1400 (Day- 3)—251.54 (234.47 to 273.48)—231.33 (203.73 to 319.27)
PGDM1400 (Day- 6)—182.23 (160.51 to 186.36)—173.81 (168.63 to 177.65)
PGDM1400 (Day- 14)—139.77 (134.94 to 146.76)—126.56 (113.27 to 146.69)
PGDM1400 (Day- 28)—70.92 (67.17 to 73.87)—71.60 (52.74 to 77.35)
PGDM1400 (Day- 56)—27.88 (26.68 to 31.56)—33.70 (19.33 to 39.98)
PGDM1400 (Day- 84)———12.26 (7.20 to 15.87)
PGDM1400 (Day-112)—5.50 (4.63 to 6.04)—4.99 (3.81 to 7.11)
PGDM1400 (Day-140)———3.49 (2.34 to 24.78)
PGDM1400 (Day-168)—1.08 (1.02 to 1.10)—1.51 (1.14 to 1.88)
PGDM1400 (Day-224)—0.26 (0.26 to 0.26)—2.21 (0.88 to 6.24)
PGDM1400 (Day-280)—0.09 (0.09 to 0.09)—0.50 (0.23 to 1.41)
PGDM1400 (Day-336)—0.02 (0.02 to 0.02)—0.25 (0.08 to 0.65)
PGDM1400 (Day-392)———0.04 (0.02 to 0.11)
PGDM1400 (Day-448)———0.02 (0.02 to 0.03)
PGT121 (Day- 0)0.05 (0.05 to 0.05)——0.05 (0.05 to 0.05)
PGT121 (Day- 3)196.57 (172.85 to 210.31)——181.38 (157.86 to 219.10)
PGT121 (Day- 6)129.35 (116.95 to 137.34)——130.98 (128.10 to 137.61)
PGT121 (Day- 14)80.12 (79.07 to 86.22)——90.47 (84.84 to 100.59)
PGT121 (Day- 28)44.46 (40.81 to 50.03)——56.75 (45.47 to 64.49)
PGT121 (Day- 56)22.08 (18.83 to 23.24)——29.32 (19.33 to 31.85)
PGT121 (Day- 84)———15.00 (8.83 to 16.35)
PGT121 (Day-112)4.03 (3.45 to 5.97)——5.82 (5.60 to 10.02)
PGT121 (Day-140)———6.08 (4.06 to 27.62)
PGT121 (Day-168)1.70 (0.88 to 3.28)——2.72 (2.02 to 3.41)
PGT121 (Day-224)0.31 (0.31 to 0.31)——4.16 (2.08 to 11.28)
PGT121 (Day-280)———1.46 (0.74 to 3.46)
PGT121 (Day-336)0.05 (0.05 to 0.11)——0.71 (0.34 to 1.43)
PGT121 (Day-392)———0.18 (0.14 to 0.49)
PGT121 (Day-448)———0.05 (0.05 to 0.19)
VRC07-523LS (Day- 0)0.01 (0.01 to 0.02)0.01 (0.01 to 0.01)0.01 (0.01 to 0.01)0.01 (0.01 to 0.01)
VRC07-523LS (Day- 3)265.97 (262.58 to 300.62)239.32 (224.13 to 264.34)173.73 (145.91 to 186.22)230.06 (199.85 to 333.96)
VRC07-523LS (Day- 6)171.02 (158.01 to 209.24)176.51 (158.50 to 183.85)171.62 (164.76 to 176.61)169.54 (155.85 to 182.30)
VRC07-523LS (Day- 14)134.44 (128.24 to 135.66)139.18 (105.71 to 155.86)105.05 (85.34 to 138.74)133.03 (120.16 to 146.62)
VRC07-523LS (Day- 28)94.58 (88.61 to 102.26)96.17 (83.80 to 110.65)87.91 (85.13 to 96.66)96.52 (94.26 to 104.18)
VRC07-523LS (Day- 56)60.53 (55.78 to 62.70)56.91 (56.03 to 58.35)56.91 (34.69 to 61.74)60.24 (53.64 to 67.05)
VRC07-523LS (Day- 84)———41.64 (31.11 to 44.37)
VRC07-523LS (Day-112)24.93 (20.69 to 26.88)31.65 (20.09 to 33.07)28.18 (11.53 to 30.55)26.07 (19.85 to 33.70)
VRC07-523LS (Day-140)———13.94 (13.09 to 44.99)
VRC07-523LS (Day-168)14.45 (12.37 to 16.66)12.57 (10.74 to 14.17)11.57 (9.73 to 12.35)9.98 (9.46 to 10.50)
VRC07-523LS (Day-224)8.47 (8.47 to 8.47)11.24 (11.24 to 11.24)—22.66 (5.51 to 39.86)
VRC07-523LS (Day-280)—3.88 (3.88 to 3.88)1.81 (0.34 to 3.33)14.85 (5.99 to 15.82)
VRC07-523LS (Day-336)1.33 (1.08 to 1.38)1.31 (1.16 to 1.46)1.48 (0.85 to 2.34)7.49 (4.31 to 10.51)
VRC07-523LS (Day-392)———2.73 (1.75 to 5.00)
VRC07-523LS (Day-448)———1.10 (0.69 to 2.37)
SecondaryMagnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants

Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.

Time frame:
Measured during Screening, Days 0, 3, 28, 56, 112, 140*, 168*, 224* Days with * are only available for T4
Reported as:
Median · Relative luminescence units (RLU)
Magnitudes of TZM-bl Cells Responses Against a Panel of Env Pseudotyped Viruses for All Participants
Relative luminescence units (RLU)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
6540.v4.c1 (Day- 0)———5.00 (5.00 to 5.00)
6540.v4.c1 (Day- 3)———13187.62 (9441.20 to 18617.3)
6540.v4.c1 (Day- 28)———2083.51 (1820.80 to 2758.25)
6540.v4.c1 (Day- 56)———774.27 (530.97 to 919.39)
6540.v4.c1 (Day-112)———82.11 (61.03 to 98.13)
6540.v4.c1 (Day-140)———45.07 (25.03 to 650.34)
6540.v4.c1 (Day-168)———14.74 (9.87 to 19.62)
6540.v4.c1 (Day-224)———27.66 (5.00 to 64.76)
CH505TF.N334S.N160A.N280D.1 (Day- 0)———5.00 (5.00 to 5.00)
CH505TF.N334S.N160A.N280D.1 (Day- 3)———13343.35 (9088.55 to 18308.4)
CH505TF.N334S.N160A.N280D.1 (Day- 28)———3000.56 (2917.48 to 3828.38)
CH505TF.N334S.N160A.N280D.1 (Day- 56)———1751.70 (1019.21 to 1968.06)
CH505TF.N334S.N160A.N280D.1 (Day-112)———339.83 (296.59 to 554.03)
CH505TF.N334S.N160A.N280D.1 (Day-140)———270.10 (176.30 to 1416.59)
CH505TF.N334S.N160A.N280D.1 (Day-168)———111.35 (86.07 to 136.63)
CH505TF.N334S.N160A.N280D.1 (Day-224)———206.62 (105.46 to 429.44)
CNE55.N160K (Day- 0)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)
CNE55.N160K (Day- 3)917.25 (686.59 to 1286.70)816.88 (725.91 to 847.67)438.49 (357.53 to 535.46)466.43 (421.07 to 1000.34)
CNE55.N160K (Day- 28)259.58 (212.45 to 323.50)188.55 (161.50 to 208.80)206.12 (171.05 to 268.36)158.46 (146.09 to 233.05)
CNE55.N160K (Day- 56)105.02 (91.83 to 118.53)91.57 (80.40 to 117.12)152.21 (95.36 to 188.88)131.95 (98.57 to 134.34)
CNE55.N160K (Day-112)28.65 (25.10 to 36.11)10.00 (10.00 to 20.95)47.58 (10.00 to 59.38)47.57 (30.49 to 65.17)
CNE55.N160K (Day-140)———18.76 (17.13 to 55.76)
CNE55.N160K (Day-168)———13.27 (9.14 to 17.41)
CNE55.N160K (Day-224)———37.80 (14.65 to 58.52)
T250-4 (Day- 0)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)5.00 (5.00 to 5.00)—
T250-4 (Day- 3)32029.39 (28181.95 to 41032.5)91301.02 (79640.01 to 114904.)35379.15 (25190.07 to 44080.8)—
T250-4 (Day- 28)6458.16 (5518.54 to 7452.56)27318.99 (23401.71 to 30312.3)13028.85 (11586.88 to 14345.8)—
T250-4 (Day- 56)2016.84 (1800.34 to 2646.68)7523.58 (6020.17 to 8716.04)6515.27 (2851.83 to 7625.68)—
T250-4 (Day-112)300.37 (266.45 to 650.96)800.00 (618.17 to 837.77)928.27 (529.97 to 1449.78)—
SecondaryMagnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants

Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against the Env-pseudotyped viruses sensitive to the bnAbs (i.e., bnAb-specific viruses) in each infusion group.

Time frame:
Measured during Screening, Days 0*, 3, 28, 56*, 112, 140*, 224* Days with * are only available for T4
Reported as:
Median · Relative luminescence units (RLU)
Magnitude of Neutralizing Activity Against a Panel of Env Pseudotyped Reference Viruses in TZM-bl Cells for All Participants
Relative luminescence units (RLU)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
0330.v4.c3 (Day- 0)———5.00 (5.00 to 5.00)
0330.v4.c3 (Day- 3)6396.28 (6080.23 to 6735.71)74297.85 (52044.99 to 88109.3)6121.19 (3340.46 to 12217.9)89412.79 (81404.07 to 133261.)
0330.v4.c3 (Day- 28)1714.47 (1464.17 to 1902.42)12264.66 (10502.90 to 16471.8)1117.61 (1052.55 to 1387.42)19794.60 (12324.14 to 23999.2)
0330.v4.c3 (Day- 56)———5217.82 (3172.08 to 6238.47)
0330.v4.c3 (Day-112)242.94 (181.50 to 300.77)1216.32 (807.32 to 1581.69)209.33 (99.69 to 222.71)611.93 (453.02 to 750.19)
0330.v4.c3 (Day-140)———589.67 (389.86 to 3617.62)
0330.v4.c3 (Day-224)———343.14 (116.53 to 669.99)
3426.v5.c17 (Day- 0)———5.00 (5.00 to 5.00)
3426.v5.c17 (Day- 3)16924.30 (14561.42 to 20967.7)144218.5 (93034.17 to 406283.)9665.13 (7360.48 to 11861.0)368712.2 (259743.1 to 390143.)
3426.v5.c17 (Day- 28)3041.45 (2966.23 to 3290.51)32852.84 (26522.32 to 46738.8)2676.34 (2001.12 to 2816.62)66390.30 (64990.87 to 97262.7)
3426.v5.c17 (Day- 56)———24227.08 (8980.36 to 33004.1)
3426.v5.c17 (Day-112)362.56 (274.34 to 473.09)1488.31 (993.10 to 1671.42)447.09 (97.17 to 463.62)1288.16 (1082.09 to 2303.78)
3426.v5.c17 (Day-140)———822.84 (540.23 to 14854.5)
3426.v5.c17 (Day-224)———537.48 (182.83 to 1909.54)
377.v4.c09 (Day- 0)———5.00 (5.00 to 5.00)
377.v4.c09 (Day- 3)441.18 (411.01 to 504.06)255.40 (209.29 to 281.66)380.32 (278.05 to 459.21)591.58 (482.75 to 800.29)
377.v4.c09 (Day- 28)108.14 (102.75 to 114.54)63.14 (58.58 to 72.02)116.45 (96.92 to 117.19)179.21 (127.50 to 211.82)
377.v4.c09 (Day- 56)———85.74 (59.71 to 97.87)
377.v4.c09 (Day-112)16.27 (12.25 to 18.09)5.00 (5.00 to 5.00)14.68 (5.00 to 15.14)17.94 (13.93 to 26.97)
377.v4.c09 (Day-140)———14.48 (9.74 to 91.02)
377.v4.c09 (Day-224)———17.09 (5.00 to 37.52)
AC10.0.29 (Day- 0)———5.00 (5.00 to 5.00)
AC10.0.29 (Day- 3)3307.09 (3201.01 to 3589.36)1198.26 (1097.26 to 1305.86)2763.45 (2425.04 to 3413.11)3854.76 (3252.76 to 5347.95)
AC10.0.29 (Day- 28)730.53 (710.40 to 751.62)285.36 (277.39 to 333.60)842.99 (802.47 to 1038.29)1039.01 (761.35 to 1117.14)
AC10.0.29 (Day- 56)———500.07 (312.83 to 597.44)
AC10.0.29 (Day-112)58.82 (50.35 to 97.12)37.55 (34.74 to 44.08)152.58 (28.49 to 154.06)85.57 (59.92 to 153.51)
AC10.0.29 (Day-140)———75.66 (51.59 to 455.20)
AC10.0.29 (Day-224)———57.51 (22.44 to 162.14)
Ce1176_A3 (Day- 0)———5.00 (5.00 to 5.00)
Ce1176_A3 (Day- 3)11645.78 (9518.45 to 12116.3)537.29 (459.87 to 586.96)4781.11 (3229.13 to 7086.33)8628.18 (6578.27 to 12370.5)
Ce1176_A3 (Day- 28)1869.57 (1853.02 to 2232.85)137.78 (109.83 to 145.47)1475.03 (954.07 to 1488.48)2081.67 (1688.46 to 2313.62)
Ce1176_A3 (Day- 56)———842.00 (564.10 to 1444.53)
Ce1176_A3 (Day-112)139.63 (95.90 to 265.94)28.13 (17.77 to 28.27)165.45 (41.81 to 206.47)199.63 (160.77 to 372.51)
Ce1176_A3 (Day-140)———205.80 (128.04 to 963.06)
Ce1176_A3 (Day-224)———101.07 (48.45 to 381.19)
DU156.12 (Day- 0)———5.00 (5.00 to 5.00)
DU156.12 (Day- 3)18539.26 (17172.56 to 23579.6)27452.85 (26185.95 to 28715.5)10841.11 (5764.85 to 14232.2)84807.92 (32946.35 to 107084.)
DU156.12 (Day- 28)4812.81 (4150.62 to 5672.03)6655.88 (5796.38 to 6937.67)2989.42 (2466.94 to 3703.45)14630.79 (12167.11 to 23357.8)
DU156.12 (Day- 56)———3915.57 (2878.16 to 5887.10)
DU156.12 (Day-112)632.13 (498.04 to 735.92)620.22 (503.29 to 741.76)629.27 (199.42 to 648.10)744.96 (605.25 to 1202.94)
DU156.12 (Day-140)———627.31 (437.57 to 4019.46)
DU156.12 (Day-224)———578.62 (161.72 to 832.75)
DU172.17 (Day- 0)———5.00 (5.00 to 5.00)
DU172.17 (Day- 3)1518.88 (1163.34 to 1850.98)448.77 (342.15 to 495.87)1315.85 (1037.49 to 1898.68)1631.83 (1393.41 to 1944.91)
DU172.17 (Day- 28)434.85 (402.56 to 448.27)170.68 (119.08 to 194.91)398.72 (383.47 to 448.60)413.93 (332.95 to 532.05)
DU172.17 (Day- 56)———187.19 (162.90 to 224.12)
DU172.17 (Day-112)45.10 (37.03 to 71.39)16.67 (5.00 to 22.47)61.30 (16.72 to 66.06)56.99 (46.08 to 78.16)
DU172.17 (Day-140)———43.33 (27.32 to 178.56)
DU172.17 (Day-224)———33.71 (11.22 to 72.76)
PVO.4 (Day- 0)———5.00 (5.00 to 5.00)
PVO.4 (Day- 3)1834.12 (1630.50 to 2102.57)773.42 (697.14 to 903.36)1918.35 (1098.33 to 2093.31)2078.34 (1885.71 to 2315.32)
PVO.4 (Day- 28)523.42 (443.00 to 527.84)244.89 (240.35 to 248.11)548.04 (529.82 to 634.73)611.64 (557.45 to 649.11)
PVO.4 (Day- 56)———316.00 (215.71 to 363.56)
PVO.4 (Day-112)80.37 (67.76 to 93.09)50.58 (46.64 to 54.40)99.15 (40.87 to 104.77)92.98 (76.81 to 112.41)
PVO.4 (Day-140)———45.61 (40.70 to 230.18)
PVO.4 (Day-224)———58.33 (20.52 to 110.43)
RHPA4259.7 (Day- 0)———5.00 (5.00 to 5.00)
RHPA4259.7 (Day- 3)15786.94 (13562.87 to 19915.2)4313.94 (3709.44 to 5821.77)6847.08 (5023.53 to 9267.51)11323.55 (10578.46 to 15367.3)
RHPA4259.7 (Day- 28)3718.80 (3383.58 to 4228.20)1748.53 (1639.88 to 1788.12)2996.20 (2164.60 to 3266.73)3560.23 (3338.05 to 3839.56)
RHPA4259.7 (Day- 56)———2114.58 (1601.57 to 2685.28)
RHPA4259.7 (Day-112)663.30 (477.36 to 857.77)506.64 (364.10 to 511.53)528.88 (267.50 to 555.36)562.77 (485.83 to 788.27)
RHPA4259.7 (Day-140)———384.75 (279.01 to 1524.80)
RHPA4259.7 (Day-224)———406.26 (131.41 to 768.36)
SC422661.8 (Day- 0)———5.00 (5.00 to 5.00)
SC422661.8 (Day- 3)3925.17 (3766.76 to 4704.83)2519.42 (1997.20 to 2761.47)3601.22 (2513.76 to 4602.54)5345.96 (3397.00 to 5947.47)
SC422661.8 (Day- 28)1389.90 (1302.50 to 1530.08)1035.29 (725.16 to 1287.34)1408.81 (1227.23 to 1411.60)1377.52 (1147.39 to 1725.51)
SC422661.8 (Day- 56)———765.08 (625.41 to 991.03)
SC422661.8 (Day-112)213.39 (186.07 to 275.41)163.39 (156.87 to 174.58)219.98 (95.53 to 267.65)189.00 (183.79 to 276.06)
SC422661.8 (Day-140)———120.06 (103.68 to 514.08)
SC422661.8 (Day-224)———192.58 (53.76 to 269.09)
T263-8 (Day- 0)———5.00 (5.00 to 5.00)
T263-8 (Day- 3)2776.59 (2281.26 to 3281.31)8794.97 (8451.76 to 11791.8)1811.12 (1236.81 to 1988.47)10506.56 (7759.25 to 12494.5)
T263-8 (Day- 28)652.72 (623.52 to 799.07)2180.36 (2077.13 to 2332.70)709.37 (659.45 to 713.01)2076.06 (2000.37 to 2452.00)
T263-8 (Day- 56)———789.69 (562.19 to 1124.91)
T263-8 (Day-112)168.55 (139.98 to 176.97)260.69 (204.99 to 326.59)156.80 (77.23 to 174.38)169.57 (128.05 to 260.28)
T263-8 (Day-140)———99.18 (83.78 to 680.21)
T263-8 (Day-224)———130.83 (36.33 to 281.58)
TRO.11 (Day- 0)———5.00 (5.00 to 5.00)
TRO.11 (Day- 3)7813.45 (7044.18 to 8400.16)887.77 (744.43 to 1025.75)4253.82 (2683.78 to 5150.14)8880.74 (6305.55 to 9378.98)
TRO.11 (Day- 28)1503.04 (1409.62 to 1726.44)249.19 (202.44 to 318.67)1085.04 (954.52 to 1375.31)1963.86 (1656.59 to 2787.73)
TRO.11 (Day- 56)———1023.42 (611.40 to 1196.50)
TRO.11 (Day-112)116.90 (101.82 to 156.21)73.93 (37.19 to 75.09)193.46 (66.49 to 206.92)182.49 (153.74 to 287.64)
TRO.11 (Day-140)———146.55 (95.84 to 783.56)
TRO.11 (Day-224)———111.00 (47.82 to 333.09)

Adverse events

Collected over The study Unsolicited AE reporting time frame is from study enrollment of a trial participant to (and including) Day 336 for T1-T3 and Day 448 for T4. The Solicited AE assessment were collected through 3 full days after each vaccination (vaccinations were given at Day 0 for T1-T4 and Day 112 for T4).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
T1: PGT121 + VRC07-523LS mo 00/6 (0%)0/6 (0%)5/6 (83.3%)
T2: PGDM1400 + VRC07-523LS mo 01/6 (16.7%)1/6 (16.7%)6/6 (100%)
T3: 10-1074 + VRC07-523LS0/6 (0%)0/6 (0%)4/6 (66.7%)
T4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)0/9 (0%)0/9 (0%)4/9 (44.4%)
Most frequent serious events
Most frequent serious events
EventT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Any Event in SOCRespiratory, thoracic and mediastinal disorders0/61/60/60/9
Respiratory distressRespiratory, thoracic and mediastinal disorders0/61/60/60/9
Most frequent other events
Showing 10 of 43
Most frequent other events
EventT1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)
Any Event in SOCInfections and infestations3/62/61/63/9
Any Event in SOCGeneral disorders2/60/61/61/9
Upper respiratory tract infectionInfections and infestations2/60/60/60/9
Any Event in SOCInjury, poisoning and procedural complications0/62/62/61/9
Any Event in SOCInvestigations1/61/62/62/9
Any Event in SOCRenal and urinary disorders0/62/61/60/9
Influenza like illnessGeneral disorders1/60/60/60/9
Infusion site extravasationGeneral disorders0/60/61/60/9
PyrexiaGeneral disorders1/60/60/60/9
COVID-19Infections and infestations0/61/60/60/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)Total
Median25 (21 to 25)29 (21 to 50)28 (25 to 49)30 (19 to 49)26 (19 to 50)
Age, Customized
Age, Customized(Participants)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)Total
Less than 18 years00000
18 - 20 years00011
21 - 30 years634417
31 - 40 years02024
41 - 50 years01225
Above 50 years00000
Unknown or Not Reported00000
Sex: Female, Male
Sex: Female, Male(Participants)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)Total
Female533516
Male133411
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)Total
Hispanic or Latino01023
Not Hispanic or Latino656724
Unknown or Not Reported00000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)Total
American Indian or Alaska Native00011
Asian11013
Native Hawaiian or Other Pacific Islander00000
Black or African American00202
White534719
More than one race01001
Other01001
Region of Enrollment
Region of Enrollment(Participants)T1: PGT121 + VRC07-523LS mo 0T2: PGDM1400 + VRC07-523LS mo 0T3: 10-1074 + VRC07-523LST4: PGT121 + PGDM1400 + VRC07-523LS mo(0, 4)Total
United States666927
08

Study locations

4 sites
  • Fenway Health (FH) CRS
    Boston, Massachusetts 02215-4302, United States
  • Harlem Prevention Center CRS
    New York, New York 10027, United States
  • Columbia P&S CRS
    New York, New York 10032-3732, United States
  • Vanderbilt Vaccine (VV) CRS
    Nashville, Tennessee 37232-2582, United States
09

References and documents

Publications

  • Sobieszczyk ME, Mannheimer S, Paez CA, Yu C, Gamble T, Theodore DA, Chege W, Yacovone M, Hanscom B, Heptinstall J, Seaton KE, Zhang L, Miner MD, Eaton A, Weiner JA, Mayer K, Kalams S, Stephenson K, Julg B, Caskey M, Nussenzweig M, Gama L, Barouch DH, Ackerman ME, Tomaras GD, Huang Y, Montefiori D; HVTN 130/HPTN 089 Study Team. Safety, tolerability, pharmacokinetics, and immunological activity of dual-combinations and triple-combinations of anti-HIV monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered intravenously to HIV-uninfected adults: a phase 1 randomised trial. Lancet HIV. 2023 Oct;10(10):e653-e662. doi: 10.1016/S2352-3018(23)00140-6. PubMed 37802566 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 4, 2019
  • Informed consent form · Jun 6, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03928821
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Apr 26, 2019
Start date
Jul 17, 2019
Primary completion
Mar 25, 2021
Completion
Mar 25, 2021
Results posted
Jul 11, 2022
Last update
Jul 11, 2022

Study contacts

Magdalena Sobieszczyk
study chair · Columbia University
Sharon Mannheimer
study chair · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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