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RecruitingNCT07757802Updated Oct 23, 2026

Phase 1 Study of CH505 HIV Vaccine Nanoparticles and mRNA Boosters in Healthy Adults

A Phase 1 interventional study of DV901-NP and DV902-NP in HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 8 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

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

Updated Oct 23, 2026Now RecruitingStart date moved+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This Phase 1 study will evaluate the safety, tolerability, and immune responses of investigational CH505 HIV vaccine regimens in adults in overall good health without HIV. Participants will receive CH505 protein nanoparticle vaccines (DV901-NP) formulated with the investigational adjuvant ACU-026-001-1, followed by either CH505 protein nanoparticle (DV902-NP) or CH505 mRNA vaccine boosters. The study will assess the ability of these regimens to induce HIV-specific immune responses, including B-cell responses associated with the development of broadly neutralizing antibodies. An immunology cohort will also evaluate how the location of booster vaccination affects immune responses.

02

Conditions studied

  • HIV

Keywords

  • Healthy Individuals
  • HIV
  • Healthy participants
03

In context

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (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 55 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

  1. Demonstrates an understanding of the study and is able and willing to complete the process.
  2. At least 18 years old at screening and up to 55 years old on day of enrollment.
  3. Available for clinic follow-up through the last clinic visit and willing to be contacted 12 months after the last study product administration of ACU-026-001-1.
  4. Willing to undergo study procedures as outlined in the schedule of procedures.
  5. Agrees not to enroll in another study of an agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals are required prior to enrollment into HVTN 324.
  6. In good general health according to the clinical judgment of the site investigator.
  7. Physical examination and laboratory results without findings that would interfere with assessment of safety or reactogenicity in the clinical judgment of the site investigator.
  8. Agrees to discuss their potential for acquisition and agrees to HIV prevention counseling.

  9. (Hgb):

    • ≥11.0 g/dL for women
    • ≥13.0 g/dL for men Note: If receiving exogenous hormones for more than 6 consecutive months with dosing equivalent to parenteral testosterone ≥1000 mg every 12 weeks or estradiol valerate ≥2 mg/week, determine hemoglobin eligibility based on the exogenous hormone reported.
  10. White blood cell (WBC) count of 2,500 to 12,000/mm3. WBC over 12,000/mm3 is not exclusionary if further evaluation shows general good health and if approval is granted.
  11. count of 125,000 to 550,000/mm3.
  12. (ALT) \<2.5× the upper limit of institutional reference range.
  13. Serum creatinine ≤1.1× the (ULN) based on the institutional normal range.
  14. Total measured serum calcium level >8.5 mg/dL (if the participant consented to have leukapheresis as a study procedure).
  15. Systolic blood pressure of 90 to \<140 mm Hg and diastolic blood pressure of 50 to \<90 mm Hg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mm Hg systolic and 90 mmHg diastolic. A single measurement of ≥160 mm Hg systolic or ≥100 mm Hg diastolic during the current study evaluation is exclusionary.

  16. Negative HIV test results by one of the following options:

    For US volunteers:

    • Negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA) or
    • Negative results on 2 different brands of HIV rapid tests (one of which must be FDA-approved)
  17. Negative for anti- virus (HCV) antibodies (Abs) or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
  18. Negative for surface antigen (Ag).

  19. For women of pregnancy potential:

    • Must agree to use effective means of from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination timepoint.
    • Must have a negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment.

    Note: Women who have had a total hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (verified by medical records), tubal ligation, or menopause (no menses for ≥1 year) are not required to undergo pregnancy testing.

  20. Women of pregnancy potential must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination timepoint.

Exclusion criteria

Exclusion Criteria:

  1. Woman who is breastfeeding or pregnant.
  2. (BMI) ≥40. Enrollment of individuals with BMI ≥40 who are in good health, as assessed by the site investigator, may be considered by approval.
  3. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with type 2 DM that is well controlled on hypoglycemic agent(s) may be considered on a case-by-case basis, provided that the HgbA1c is ≤8% within the last 6 months (sites may draw these at screening).
  4. Previous or current recipient of an vaccine (previous placebo/control recipients are not excluded).
  5. Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.
  6. Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as use or prednisone dose of ≥10 mg/day, within 3 months prior to enrollment.
  7. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires approval.

  8. Receipt of any of the following within 4 weeks prior to enrollment:

    • Live replicating vaccine
    • Any mRNA-based vaccine with FDA licensure, FDA EUA, or WHO EUL
    • ACAM2000 vaccine more than 28 days prior with a vaccination scab still present
  9. Receipt of any vaccine that is not covered in exclusion criterion #8 within 14 days prior to enrollment. Please note this includes replication-incompetent vaccines such as the Jynneos vaccine for the prevention of mpox (formerly known as monkeypox) disease.
  10. History of myocarditis and/or pericarditis.
  11. Initiation of Ag-based immunotherapy for allergies within the past year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires approval.
  12. Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life of more than 7 days (or unknown half-life) within the past year, approval is required for enrollment.
  13. History of serious reaction (eg, , anaphylaxis) to any related vaccine, to any mRNA vaccine, including Comirnaty (Pfizer) and Spikevax (Moderna), or to any drug administered systemically as a polyethylene glycol containing LNP, including doxorubicin (Doxil, Caelyx, ThermoDox), cisplatin (Lipoplatin) and irinotecan (Onivyde).
  14. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
  15. History of chronic urticaria, urticaria associated with previous vaccination, or any urticarial episode within the past year.
  16. Bleeding disorder (eg, factor deficiency, coagulopathy, or disorder requiring special precautions) diagnosed by a clinician, or current therapeutic systemic anticoagulation for any clinical indication. Systemic anticoagulation includes oral anticoagulants (eg, warfarin, dabigatran, rivaroxaban, apixaban, edoxaban), injectable anticoagulants (eg, low-molecular-weight heparin, unfractionated heparin), or other similar prescription anticoagulants.
  17. History of seizure(s) within the past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
  18. Asplenia or functional asplenia.
  19. Active duty and reserve US military personnel.
  20. Any other chronic or condition that, in the clinical judgment of the investigator, would jeopardize the safety or rights of the study participant, including but not limited to clinically significant forms of substance use or alcohol use disorder(s), serious psychiatric disorders, any recent suicide attempt, or cancer that, in the clinical judgment of the site investigator, has potential for recurrence (excluding basal cell carcinoma).

  21. Asthma is excluded if the volunteer meets any of the following criteria:

    • Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year
    • Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would not exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or coexisting conditions unrelated to asthma)
    • Uses a short-acting rescue inhaler more than 2 days per week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity)
    • Uses medium- to high-dose inhaled corticosteroids (>250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA])
    • Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires approval.
  22. A volunteer with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Specific examples are listed in Appendix I (AESI index). Not exclusionary: (1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms; (2) mild psoriasis or other mild, uncomplicated, localized, or dermatologic condition that does not require ongoing systemic treatment; (3) remote history (>10 years ago) of Kawasaki disease without sequelae; (4) celiac disease well controlled for 6 months with diet only.
  23. History of allergy to local anesthetic (Novocaine, Lidocaine).
  24. Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of intravenous drug use or substantial difficulty with previous blood draws.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Group 1: DV901-NP Low-Dose Prime/DV902-NP Low-Dose Boost

    Participants receive DV901-NP (100 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral intramuscular (IM) injection at Weeks 0 and 8, followed by DV902-NP (100 mcg) adjuvanted with ACU-026-001-1 (2 mg) at Weeks 16 and 24.

    Biological: DV901-NP · Biological: DV902-NP · Biological: ACU-026-001-1

  • Experimental
    Group 2: DV901-NP High-Dose Prime/DV902-NP High-Dose Boost

    Participants receive DV901-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral IM injection at Weeks 0 and 8, followed by DV902-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) at Weeks 16 and 24.

    Biological: DV901-NP · Biological: DV902-NP · Biological: ACU-026-001-1

  • Experimental
    Group 3: DV901-NP Prime/CH505 mRNA Boosts

    Participants receive DV901-NP (300 mcg) adjuvanted with ACU-026-001-1 (2 mg) by bilateral IM injection at Weeks 0 and 8, followed by CH505 TF mRNA-gp160 (100 mcg) at Weeks 16 and 24 and CH505 w24 mRNA-gp160 (100 mcg) at Week 32.

    Biological: DV901-NP · Biological: CH505 TF mRNA-gp160 · Biological: CH505 w24 mRNA-gp160 · Biological: ACU-026-001-1

  • Experimental
    Group 4: Ipsilateral Prime/Contralateral Boost Immunology Cohort

    Participants receive DV901-NP (150 mcg) adjuvanted with ACU-026-001-1 (1 mg) by IM injection at Weeks 0, 4, and 28. The Week 0 and Week 4 vaccinations are administered in the same deltoid (ipsilateral), and the Week 28 vaccination is administered in the opposite deltoid (contralateral).

    Biological: DV901-NP · Biological: ACU-026-001-1

  • Experimental
    Group 5: Ipsilateral Prime/Ipsilateral Boost Immunology Cohort

    Participants receive DV901-NP (150 mcg) adjuvanted with ACU-026-001-1 (1 mg) by IM injection at Weeks 0, 4, and 28, with all vaccinations administered in the same deltoid (ipsilateral).

    Biological: DV901-NP · Biological: ACU-026-001-1

Interventions

  • BiologicalDV901-NP

    CH505 HIV-1 envelope protein nanoparticle vaccine administered intramuscularly at doses of 100 mcg, 150 mcg, or 300 mcg, depending on study group. Administered with ACU-026-001-1 adjuvant.

  • BiologicalDV902-NP

    CH505 HIV-1 envelope protein nanoparticle booster vaccine administered intramuscularly at doses of 100 mcg or 300 mcg with ACU-026-001-1 adjuvant.

  • BiologicalCH505 TF mRNA-gp160

    CH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Weeks 16 and 24.

  • BiologicalCH505 w24 mRNA-gp160

    CH505 HIV-1 envelope mRNA vaccine administered intramuscularly as a 100 mcg booster at Week 32.

  • BiologicalACU-026-001-1

    Investigational lipid nanoparticle adjuvant administered in combination with DV901-NP or DV902-NP. Dose is 2 mg for Groups 1-3 and 1 mg for Groups 4-5.

06

What researchers measure

Primary outcomes

  1. Incidence of solicited local reactogenicity

    Incidence and severity of solicited local reactogenicity following study vaccination.

    Time frame: Through 14 days after each study vaccination

  2. Incidence of solicited systemic reactogenicity

    Incidence and severity of solicited systemic reactogenicity following study vaccination.

    Time frame: Through 14 days after each study vaccination

  3. Incidence of adverse events

    Incidence of adverse events following study vaccination.

    Time frame: Through 30 days after each study vaccination

  4. Incidence of serious adverse events

    Incidence of serious adverse events (SAEs).

    Time frame: Through 52 weeks after the last study vaccination

  5. Incidence of medically attended adverse events

    Incidence of medically attended adverse events (MAAEs).

    Time frame: Through 52 weeks after the last study vaccination

  6. Incidence of adverse events of special interest

    Incidence of adverse events of special interest (AESIs)

    Time frame: Through 52 weeks after the last study vaccination

  7. Incidence of adverse events leading to permanent discontinuation of study product or participant withdrawal

    Incidence of adverse events resulting in permanent discontinuation of study product administration or participant withdrawal.

    Time frame: Through 52 weeks after the last study vaccination

  8. Frequency of CH505M5.G458Y/GnT1neg-specific IgG+ memory B cells

    Frequency of CH505M5.G458Y/GnT1neg-specific IgG+ memory B cells measured by flow cytometry.

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  9. Response rate of precursor-specific serum neutralizing antibodies

    Response rate of differential serum neutralizing antibody activity against precursor detection viruses and corresponding epitope knockout viruses measured by TZM-bl assay.

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  10. Magnitude of precursor-specific serum neutralizing antibodies

    Magnitude of differential serum neutralizing antibody activity against precursor detection viruses and corresponding epitope knockout viruses measured by TZM-bl assay.

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

Secondary outcomes

  1. Response rate of HIV Env-specific serum IgG binding antibodies

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  2. Magnitude of HIV Env-specific serum IgG binding antibodies as measured by binding Ab multiplex assay (BAMA)

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  3. Epitope specificity of HIV Env-specific serum IgG binding antibodies

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  4. Response rate of ferritin-specific serum IgG binding antibodies

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  5. Magnitude of ferritin-specific serum IgG binding antibodies as measured by binding Ab multiplex assay (BAMA)

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  6. Epitope specificity of ferritin-specific serum IgG binding antibodies

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); baseline and 2 weeks after the second, fourth, and fifth vaccinations (Group 3)

  7. Epitope-specific antibody responses measured by EMPEM

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  8. Response rate of antibodies blocking soluble CD4 binding to HIV Env

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  9. Magnitude of antibodies blocking soluble CD4 binding to HIV Env as measured by competition ELISA

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  10. Response rate of antibodies blocking CH235.12 binding to HIV Env

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  11. Magnitude of antibodies blocking CH235.12 binding to HIV Env as measured by competition ELISA

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  12. Response rate of serum neutralization against the broadly neutralizing antibody maturation panel

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  13. Magnitude of serum neutralization against the broadly neutralizing antibody maturation panel as measured by TZM-bl assay

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  14. Response rate of serum neutralization against heterologous Tier 2 HIV-1 strains

    Time frame: Two weeks after the fourth vaccination (Groups 1 and 2); two weeks after the fourth and fifth vaccinations (Group 3)

  15. Magnitude of serum neutralization against heterologous Tier 2 HIV-1 strains

    Time frame: Two weeks after the fourth vaccination (Groups 1 and 2); two weeks after the fourth and fifth vaccinations (Group 3)

  16. Frequency of CH235-like B-cell receptor sequences

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  17. Frequency of other CD4 binding site-like B-cell receptor sequences

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  18. Response rate of heterologous CD4 binding site Env-specific IgG+ B cells

    Time frame: Baseline and 2 weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  19. Response rate of antibodies blocking DH1029 binding to HIV Env

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  20. Magnitude of antibodies blocking DH1029 binding to HIV Env as measured by competition ELISA

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  21. Response rate of antibodies blocking RM19R binding to HIV Env

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  22. Magnitude of antibodies blocking RM19R binding to HIV Env as measured by competition ELISA

    Time frame: Two weeks after the second and fourth vaccinations (Groups 1 and 2); two weeks after the second, fourth, and fifth vaccinations (Group 3)

  23. Plasmablast response using B-cell sorting, single-cell RT-PCR, 10x genomics RNA sequencing

    Time frame: One week after the second and third vaccinations (Groups 4 and 5)

  24. Vaccine-specific Germinal center B-cell clonality using single cell sorting against vaccine antigen and determination of BCR sequences

    Time frame: One week after the second vaccination and 3 weeks after the third vaccination (Groups 4 and 5)

  25. Vaccine-specific Germinal center relative B-cell receptor somatic hypermutation using single cell sorting against vaccine antigen and determination of BCR sequences

    Time frame: One week after the second vaccination and 3 weeks after the third vaccination (Groups 4 and 5)

  26. Vaccine-specific Peripheral B-cell clonal diversity using single-cell sorting against vaccine antigen and determination of BCR sequences via NGS

    Time frame: Prior to and 9 weeks after the third vaccination (Groups 4 and 5)

  27. Vaccine-specific Peripheral relative B-cell receptor somatic hypermutation using single-cell sorting against vaccine antigen and determination of BCR sequences via NGS

    Time frame: Prior to and 9 weeks after the third vaccination (Groups 4 and 5)

  28. Response rate of HIV Env-specific serum IgG binding antibodies following homologous boosting

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  29. Magnitude of HIV Env-specific serum IgG binding antibodies following homologous boosting as measured by BAMA

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  30. Epitope specificity of HIV Env-specific serum IgG binding antibodies following homologous boosting

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  31. Response rate of ferritin-specific serum IgG binding antibodies following homologous boosting

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  32. Magnitude of ferritin-specific serum IgG binding antibodies following homologous boosting as measured by BAMA

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  33. Epitope specificity of ferritin-specific serum IgG binding antibodies following homologous boosting

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  34. Response rate of precursor-specific serum neutralizing antibodies following homologous boosting

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

  35. Magnitude of precursor-specific serum neutralizing antibodies following homologous boosting as measured by TZM-bl assay

    Time frame: Baseline and 2 weeks after the second and third vaccinations (Groups 4 and 5)

07

Study locations

2 of 8 sites recruiting
08

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

Start moved 3 times since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, last on Oct 23, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2026
First posted
Aug 11, 2026
StartEst.
Dec 1, 2026was Sep 2026
Primary completionEst.
Jun 7, 2028
CompletionEst.
Oct 7, 2028
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 9, 2026
Sites
8 sites changed recruiting status (6 now not yet recruiting, 2 now recruiting)
Show 8 sites
  • Bridge HIV CRS Site# 30305 · San Francisco, United Statesno status→Not yet recruiting
  • The Ponce de Leon Center CRS Site# 5802 · Atlanta, United Statesno status→Not yet recruiting
  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Site# 30007 · Boston, United Statesno status→Recruiting
  • BIDMC VCRS Site# 32077 · Boston, United Statesno status→Not yet recruiting
  • University of Rochester Vaccines to Prevent HIV Infection CRS Site# 31467 · Rochester, United Statesno status→Not yet recruiting
  • Penn Prevention CRS Site# 30310 · Philadelphia, United Statesno status→Not yet recruiting
  • University of Pittsburgh CRS Site# 1001 · Pittsburgh, United Statesno status→Recruiting
  • Vanderbilt Vaccine (VV) CRS Site# 30352 · Nashville, United Statesno status→Not yet recruiting
Oct 9, 2026
Start date
Sep 10, 2026→Dec 1, 2026
moved 3 times, Sep 28, 2026 – Oct 23, 2026
Site contacts
Changed at 8 sites. See the sites
Show 8 sites
  • Bridge HIV CRS Site# 30305 · San Francisco, United StatesContact •••1085→•••1085
  • The Ponce de Leon Center CRS Site# 5802 · Atlanta, United StatesContact e•••@emory.edu · •••6313→e•••@emory.edu · •••6313
  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Site# 30007 · Boston, United StatesContact •••9433→•••9433
  • BIDMC VCRS Site# 32077 · Boston, United StatesContact •••4463→•••4463
  • University of Rochester Vaccines to Prevent HIV Infection CRS Site# 31467 · Rochester, United StatesContact •••2768→•••2768
  • Penn Prevention CRS Site# 30310 · Philadelphia, United StatesContact •••3713→•••3713
  • University of Pittsburgh CRS Site# 1001 · Pittsburgh, United StatesContact •••1748→•••1748Contact e•••@upmc.edu%0d→e•••@upmc.edu
  • Vanderbilt Vaccine (VV) CRS Site# 30352 · Nashville, United StatesContact •••6906→•••6906
across 2 updates, Sep 28, 2026 – Oct 9, 2026
Show all 3 updates
  1. Oct 23, 2026
    Start date Oct 19, 2026→Dec 1, 2026
    + 1 other change: identifiers
  2. Oct 9, 2026
    Not yet recruiting→Recruiting
    8 sites changed recruiting status (6 now not yet recruiting, 2 now recruiting)
    Show 8 sites
    • Bridge HIV CRS Site# 30305 · San Francisco, United Statesno status→Not yet recruiting
    • The Ponce de Leon Center CRS Site# 5802 · Atlanta, United Statesno status→Not yet recruiting
    • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Site# 30007 · Boston, United Statesno status→Recruiting
    • BIDMC VCRS Site# 32077 · Boston, United Statesno status→Not yet recruiting
    • University of Rochester Vaccines to Prevent HIV Infection CRS Site# 31467 · Rochester, United Statesno status→Not yet recruiting
    • Penn Prevention CRS Site# 30310 · Philadelphia, United Statesno status→Not yet recruiting
    • University of Pittsburgh CRS Site# 1001 · Pittsburgh, United Statesno status→Recruiting
    • Vanderbilt Vaccine (VV) CRS Site# 30352 · Nashville, United Statesno status→Not yet recruiting
    Start date Oct 1, 2026→Oct 19, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • The Ponce de Leon Center CRS Site# 5802 · Atlanta, United StatesContact e•••@emory.edu · •••6313→e•••@emory.edu · •••6313
    + 1 other change: verification date
  3. Sep 28, 2026
    Start date Sep 10, 2026→Oct 1, 2026
    Site contacts Changed at 8 sites. See the sites
    Show 8 sites
    • Bridge HIV CRS Site# 30305 · San Francisco, United StatesContact •••1085→•••1085
    • The Ponce de Leon Center CRS Site# 5802 · Atlanta, United StatesContact •••6313→•••6313
    • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Site# 30007 · Boston, United StatesContact •••9433→•••9433
    • BIDMC VCRS Site# 32077 · Boston, United StatesContact •••4463→•••4463
    • University of Rochester Vaccines to Prevent HIV Infection CRS Site# 31467 · Rochester, United StatesContact •••2768→•••2768
    • Penn Prevention CRS Site# 30310 · Philadelphia, United StatesContact •••3713→•••3713
    • University of Pittsburgh CRS Site# 1001 · Pittsburgh, United StatesContact •••1748→•••1748Contact e•••@upmc.edu%0d→e•••@upmc.edu
    • Vanderbilt Vaccine (VV) CRS Site# 30352 · Nashville, United StatesContact •••6906→•••6906
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07757802
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 7, 2028 (estimated)
Completion
Oct 7, 2028 (estimated)
Last update
Oct 23, 2026

Oversight

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

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Studies of the drug tested here: ACU-026-001

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