A Phase 1 interventional study of VRC-HIVAAV070-00-GT (AAV8-VRC07) in HIV-1 Infected Adults With Controlled Viremia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
Background:
The Human Immunodeficiency Virus (HIV) attacks the immune system. Scientists have created a gene that could be transferred to the cells of people with HIV. The gene should tell the cells to make an antibody called VRC07. This antibody fights HIV. The VRC07 gene is packaged into a man-made version of a virus called AAV8.
Objectives:
To see if AAV8-VRC07 is safe. To study if it causes cells to produce the VRC07 antibody.
Eligibility:
Adults ages 18-65 who are HIV infected but in general good health and have been taking the same HIV medicine for at least 3 months
Design:
Participants were screened in a different protocol.
Participants received the study product on day 1. It was injected one or more times in the upper arm or thigh using a needle. Participants weight was measured to calculate the dose.
Women may have had a pregnancy test.
For 7 days after getting the study product, participants checked their temperature with a thermometer. They noted any symptoms in an electronic or paper diary.
Participants will have study visits. At each one, they will have a physical exam and medical history. They will have blood drawn and may have saliva collected.
The study visit schedule is as follows:
For 12 weeks: 1 visit a week
For the next 12 weeks: 1 visit every other week
Then about 1 visit a month
After 1 year in the study: a visit every 6 months for the next 4 years.
Total study participation is 5 years.
Design: This is a Phase I study of the safety and tolerability of AAV8-VRC07 (VRC-HIVAAV070-00-GT) expressing VRC07 human monoclonal antibody with broad HIV-1 neutralizing activity in HIV-1 infected adults. It is a dose-escalation study to examine pharmacokinetics of VRC07 expression following intramuscular (IM) administration of AAV8-VRC07 in participants on anti-retroviral therapy (ARV). The hypotheses are: 1) AAV8-VRC07 will be safe for human administration and will not elicit hypersensitivity or anti-drug antibody (ADA) to VRC07; and 2) intramuscular delivery of AAV8-VRC07 will result in production of biologically active VRC07 antibody at a concentration in serum that is measurable and safe.
Description: AAV8-VRC07 was developed by VRC, NIAID, NIH, and manufactured by the Clinical Vector Core, Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania (PA). It is composed of an AAV8 recombinant vector expressing genes encoding the heavy and light chains of the VRC07 monoclonal antibody. AAV8-VRC07 was supplied at 2.84 x 10\^13 vector genomes (vg)/mL.
Participants: HIV-1 infected adult volunteers (18 to 65 years old) on a stable antiretroviral regimen for more than or equal to 3 months, with controlled viremia, under the care of a physician, and without additional clinically significant medical conditions.
Study Plan: There are 3 dose escalation groups. Sequentially enrolled participants were assigned to the dosage level being evaluated at the time of enrollment. All injections were administered intramuscularly (IM) by needle and syringe. Cumulative safety data were reviewed weekly by a Protocol Safety Review Team (PSRT) that included an Independent Safety Monitor (ISM) while injections were being administered. Safety, including reactogenicity and unsolicited adverse events (AEs), laboratory findings, pharmacokinetics, and VRC07 antibody levels in blood were assessed after the injection and summarized for an interim analysis at 4 weeks post injection. The second participant in each dose group was injected after the 4 weeks safety assessment for the first participant. Decisions regarding dose escalation and participant enrollments were based on safety data and the VRC07 concentration in blood at 4 weeks after product administration. The pharmacokinetics of VRC07 at each dose level was evaluated to determine the dose that would result in antibody production that achieves at least 50 mcg/mL VRC07 concentration in serum at 4 weeks post injection with a target set point of more than or equal to 5 mcg/mL at 12 weeks post injection.
57 studies on the registry are indexed under Viremia; 12 are open to participants now.
This study's enrollment of 10 is below the median of 87 across 45 interventional studies indexed under Viremia.
Browse Viremia studies →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.
Counted across the registry records on this site, refreshed daily.
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.
A volunteer must have met all of the following criteria:
Laboratory tests assessing individual's health will be conducted within 84 days prior to enrollment and values must meet the following criteria:
Viral Load (VL) less than or equal to 50 copies/mL and a greater than or equal to 300/mcL (microliter).
Male-Specific Criteria:
Female-Specific Criteria:
EXCLUSION CRITERIA:
A volunteer would have been excluded if one or more of the following conditions applied:
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.
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.
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.
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.
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.
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).
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.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AAV8-VRC07 (5 x 10\^10 vg/kg) administered by intramuscular (IM) injection (Day 0)
Genetic: VRC-HIVAAV070-00-GT (AAV8-VRC07)
AAV8-VRC07 (5 x 10\^11 vg/kg) administered by IM injection (Day 0)
Genetic: VRC-HIVAAV070-00-GT (AAV8-VRC07)
AAV8-VRC07 (2.5 x 10\^12 vg/kg) administered by IM injection (Day 0)
Genetic: VRC-HIVAAV070-00-GT (AAV8-VRC07)
AAV8-VRC07 is a recombinant AAV vector expressing a HIV-1 CD4 binding site-specific neutralizing antibody, VRC07
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of AAV8-VRC07 Product Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame: 7 days after AAV8-VRC07 product administration, at approximately Week 1
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of AAV8-VRC07 Product Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame: 7 days after AAV8-VRC07 product administration, at approximately Week 1
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following AAV8-VRC07 Product Administration
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) post-product administration visit. After the Day 56 (8 weeks) post-product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that require ongoing medical management (reported as a separate outcome) will be recorded through the last study visit. The relationship between a non-serious AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through 8 weeks after AAV8-VRC07 product administration
Number of Participants With Abnormal Laboratory Measures of Safety Following AAV8-VRC07 Product Administration
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, and neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine). Complete Blood Count (CBC) with differential and chemistry (ALT, AST and creatinine) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
Time frame: Day 0 through 8 weeks after AAV8-VRC07 product administration
Geometric Mean Endpoint Titer of Anti-AAV8 Antibodies
Anti-AAV8 antibodies were analyzed by enzyme-linked immunosorbent assay (ELISA) using a vector-matched AAV8 capsid as the capture agent. Group geometric means and 95% confidence intervals (CIs) for the endpoint titers for the AAV8 ELISA assay are reported at baseline, week 12 for the peak response, and week 44 for durability. Values below the lower limit of detection (LOD) were imputed to the lower LOD (30) and values above the assay upper LOD were imputed to the upper LOD (21870).
Time frame: Day 0 through 44 Weeks after AAV8-VRC07 product administration
Number of Participants Who Attained A 50 mcg/mL VRC07 Serum Concentration
In order to determine the optimal AAV8-VRC07 dose, participants must have attained a 50 mcg/mL VRC07 Serum Concentration. If no participants attained at least 50 mcg/mL VRC07 serum concentration, then the optimal AAV8-VRC07 dose cannot be determined.
Time frame: Day 0 through 52 Weeks after AAV8-VRC07 product administration
Geometric Mean Concentration of VRC07 Serum Antibodies (PK ELISA)
For the pharmacokinetic (PK) primary outcome analysis, PK ELISA detected VRC07 serum antibodies in mcg/mL, using the VRC01 anti-idiotype Fab specific 5C9 monoclonal antibody (mAb). Only visits that had detectable PK ELISA concentrations for any participant are reported. Results are reported in group geometric mean mcg/mL concentrations with 95% CIs. The protocol specifies that a more sensitive assay can also be used; the more sensitive Singulex assay results are reported later in the secondary outcome measure. Values below the lower limit of detection (LOD) were imputed to the lower LOD (1 mcg/mL) with no 95% CI.
Time frame: Day 0 through 52 Weeks after AAV8-VRC07 product administration
Number of Participants With Serious Adverse Events (SAEs) Following AAV8-VRC07 Product Administration
SAEs are recorded from receipt of study product through the last expected study visit at Year 5 (260 weeks). The relationship between a SAE and the study product is assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through 5 Years (260 weeks) after AAV8-VRC07 product administration
Number of Participants With New Chronic Medical Conditions Following AAV8-VRC07 Product Administration
New chronic medical conditions are recorded from receipt of study product through the last expected study visit at Year 5 (260 weeks). The relationship between a new chronic medical condition and the study product is assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through 5 Years (260 weeks) after AAV8-VRC07 product administration
Number of Participants Who Produced VRC07 Anti-drug Antibodies (ADA)
A three-tiered assay was used for ADA evaluation. The tier 1 screening assay measures specific and non-specific binding of serum proteins to VRC07 and the assay membrane. The tier 2 assay is a qualitative competition assay in which exogenously added VRC07 removes any VRC07-binding proteins from the serum prior to the binding assay. If the addition of the exogenous VRC07 results in a reduction of signal, the specificity of VRC07 binding is confirmed. The tier 3 assay is a qualitative assay that assesses the ability of VRC07-binding serum protein to prevent VRC07-mediated neutralization of an HIV pseudovirus in vitro. Only samples positive for a tier will be analyzed in subsequent tiers.
Time frame: Day 0 through 5 Years (260 weeks) after AAV8-VRC07 product administration
Geometric Mean Value of CD4 Cell Counts
The clinical effects of pAAV8-VRC07 on cluster of differentiation 4 (CD4) cell count were assessed. CD4 Cell Count (cells/mL) shown as reported by the Clinical Center serology lab. Values are reported as group geometric means and 95% CIs.
Time frame: Day 0 through 44 Weeks after AAV8-VRC07 product administration
Viral Load
The clinical effects of pAAV8-VRC07 on viral load were assessed. Viral Load is expressed in polymerase chain reaction (PCR) copies/mL, as reported by the Clinical Center serology lab. Values below the limit of quantification (\<20 copies/mL) or none detected were imputed to 10 copies/mL. Results are displayed as median(range).
Time frame: Day 0 through 44 Weeks after AAV8-VRC07 product administration
Concentration of VRC07 Serum Antibodies (Singulex Assay)
The serum concentration of VRC07 at specified time intervals for 1 year after injection was determined, and if persistent, then every 6 months as long as there is detectable antibody in serum. The PK Singulex assay utilizes a microparticle-based immunoassay coupled with a fluorescent detection system to detect serum antibodies in the ng/mL range. Values below the limit of detection or none detected were set to 0.10 ng/mL; therefore, a value of 0.10 ng/mL means that the VRC07 concentration for that assay was below the limit of detection. Results are displayed as median(range).
Time frame: Day 0 through 52 weeks after AAV8-VRC07 product administration
Volunteers were recruited for the study at the NIH Clinical Center in Bethesda, Maryland, USA. Adults who were HIV infected but in general good health and had been taking the same HIV medicine for at least 3 months were enrolled.
| Milestone | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Started | 3 | 3 | 4 |
| Received study product | 3 | 3 | 4 |
| Completed | 3 | 3 | 4 |
| Not completed | 0 | 0 | 0 |
| Milestone | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Started | 3 | 3 | 4 |
| Completed | 2 | 0 | 0 |
| Not completed | 1 | 3 | 4 |
| Withdrew: Long term follow up ongoing | 1 | 2 | 4 |
| Withdrew: Death | 0 | 1 | 0 |
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
| Participants | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Pain/Tenderness — None | 3 | 3 | 0 |
| Pain/Tenderness — Mild | 0 | 0 | 4 |
| Pain/Tenderness — Moderate | 0 | 0 | 0 |
| Pain/Tenderness — Severe | 0 | 0 | 0 |
| Swelling — None | 3 | 3 | 4 |
| Swelling — Mild | 0 | 0 | 0 |
| Swelling — Moderate | 0 | 0 | 0 |
| Swelling — Severe | 0 | 0 | 0 |
| Redness — None | 3 | 3 | 4 |
| Redness — Mild | 0 | 0 | 0 |
| Redness — Moderate | 0 | 0 | 0 |
| Redness — Severe | 0 | 0 | 0 |
| Any Local Symptom — None | 3 | 3 | 0 |
| Any Local Symptom — Mild | 0 | 0 | 4 |
| Any Local Symptom — Moderate | 0 | 0 | 0 |
| Any Local Symptom — Severe | 0 | 0 | 0 |
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
| Participants | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Malaise — None | 3 | 3 | 4 |
| Malaise — Mild | 0 | 0 | 0 |
| Malaise — Moderate | 0 | 0 | 0 |
| Malaise — Severe | 0 | 0 | 0 |
| Myalgia — None | 3 | 2 | 3 |
| Myalgia — Mild | 0 | 1 | 1 |
| Myalgia — Moderate | 0 | 0 | 0 |
| Myalgia — Severe | 0 | 0 | 0 |
| Headache — None | 3 | 3 | 2 |
| Headache — Mild | 0 | 0 | 2 |
| Headache — Moderate | 0 | 0 | 0 |
| Headache — Severe | 0 | 0 | 0 |
| Chills — None | 3 | 3 | 4 |
| Chills — Mild | 0 | 0 | 0 |
| Chills — Moderate | 0 | 0 | 0 |
| Chills — Severe | 0 | 0 | 0 |
| Nausea — None | 3 | 3 | 4 |
| Nausea — Mild | 0 | 0 | 0 |
| Nausea — Moderate | 0 | 0 | 0 |
| Nausea — Severe | 0 | 0 | 0 |
| Temperature (Fever) — None | 3 | 3 | 4 |
| Temperature (Fever) — Mild | 0 | 0 | 0 |
| Temperature (Fever) — Moderate | 0 | 0 | 0 |
| Temperature (Fever) — Severe | 0 | 0 | 0 |
| Joint Pain — None | 3 | 3 | 4 |
| Joint Pain — Mild | 0 | 0 | 0 |
| Joint Pain — Moderate | 0 | 0 | 0 |
| Joint Pain — Severe | 0 | 0 | 0 |
| Any Systemic Symptom — None | 3 | 2 | 2 |
| Any Systemic Symptom — Mild | 0 | 1 | 2 |
| Any Systemic Symptom — Moderate | 0 | 0 | 0 |
| Any Systemic Symptom — Severe | 0 | 0 | 0 |
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) post-product administration visit. After the Day 56 (8 weeks) post-product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that require ongoing medical management (reported as a separate outcome) will be recorded through the last study visit. The relationship between a non-serious AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
| Participants | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Related to Study Product | 1 | 0 | 1 |
| Unrelated to Study Product | 1 | 2 | 1 |
| Total Number of Participants who had One or More Non-Serious Unsolicited AE after AAV8-VRC07 Given | 2 | 2 | 2 |
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, and neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine). Complete Blood Count (CBC) with differential and chemistry (ALT, AST and creatinine) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
| Participants | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Aspartate aminotransferase (AST) | 2 | 0 | 0 |
| Creatinine | 1 | 0 | 2 |
| Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 1 | 0 | 1 |
| Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 1 | 0 | 1 |
| Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 2 | 0 | 2 |
Anti-AAV8 antibodies were analyzed by enzyme-linked immunosorbent assay (ELISA) using a vector-matched AAV8 capsid as the capture agent. Group geometric means and 95% confidence intervals (CIs) for the endpoint titers for the AAV8 ELISA assay are reported at baseline, week 12 for the peak response, and week 44 for durability. Values below the lower limit of detection (LOD) were imputed to the lower LOD (30) and values above the assay upper LOD were imputed to the upper LOD (21870).
| titer | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Baseline, Week 0 (Visit 02) | 30 (NA to NA) | 30 (NA to NA) | 156 (84 to 290) |
| Week 12 (Visit 14) | 5055 (2466 to 10361) | 10514 (5129 to 21552) | 21870 (21870 to 21870) |
| Week 44 (Visit 25) | 5055 (1203 to 21238) | 7290 (2103 to 25272) | 21870 (21870 to 21870) |
In order to determine the optimal AAV8-VRC07 dose, participants must have attained a 50 mcg/mL VRC07 Serum Concentration. If no participants attained at least 50 mcg/mL VRC07 serum concentration, then the optimal AAV8-VRC07 dose cannot be determined.
| Participants | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Number of Participants Who Attained A 50 mcg/mL VRC07 Serum Concentration | 0 | 0 | 0 |
For the pharmacokinetic (PK) primary outcome analysis, PK ELISA detected VRC07 serum antibodies in mcg/mL, using the VRC01 anti-idiotype Fab specific 5C9 monoclonal antibody (mAb). Only visits that had detectable PK ELISA concentrations for any participant are reported. Results are reported in group geometric mean mcg/mL concentrations with 95% CIs. The protocol specifies that a more sensitive assay can also be used; the more sensitive Singulex assay results are reported later in the secondary outcome measure. Values below the lower limit of detection (LOD) were imputed to the lower LOD (1 mcg/mL) with no 95% CI.
| mcg/mL | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Week 28 (Visit 21) | 1 (NA to NA) | 1.10 (0.89 to 1.34) | 1 (NA to NA) |
| Week 36 (Visit 23) | 1 (NA to NA) | 1.08 (0.92 to 1.25) | 1 (NA to NA) |
| Week 44 (Visit 25) | 1 (NA to NA) | 1.04 (0.96 to 1.12) | 1 (NA to NA) |
| Week 52 (Visit 27) | 1 (NA to NA) | 1.42 (0.41 to 2.82) | 1 (NA to NA) |
SAEs are recorded from receipt of study product through the last expected study visit at Year 5 (260 weeks). The relationship between a SAE and the study product is assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Results for this outcome have not been posted.
New chronic medical conditions are recorded from receipt of study product through the last expected study visit at Year 5 (260 weeks). The relationship between a new chronic medical condition and the study product is assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Results for this outcome have not been posted.
A three-tiered assay was used for ADA evaluation. The tier 1 screening assay measures specific and non-specific binding of serum proteins to VRC07 and the assay membrane. The tier 2 assay is a qualitative competition assay in which exogenously added VRC07 removes any VRC07-binding proteins from the serum prior to the binding assay. If the addition of the exogenous VRC07 results in a reduction of signal, the specificity of VRC07 binding is confirmed. The tier 3 assay is a qualitative assay that assesses the ability of VRC07-binding serum protein to prevent VRC07-mediated neutralization of an HIV pseudovirus in vitro. Only samples positive for a tier will be analyzed in subsequent tiers.
Results for this outcome have not been posted.
The clinical effects of pAAV8-VRC07 on cluster of differentiation 4 (CD4) cell count were assessed. CD4 Cell Count (cells/mL) shown as reported by the Clinical Center serology lab. Values are reported as group geometric means and 95% CIs.
| cells/mL | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Baseline, Week 0 (Visit 02) | 499 (447 to 557) | 599 (339 to 1057) | 551 (404 to 750) |
| Week 12 (Visit 14) | 519 (446 to 604) | 595 (389 to 908) | 557 (463 to 669) |
| Week 25 (Visit 44) | 574 (402 to 820) | 629 (547 to 723) | 548 (412 to 729) |
The clinical effects of pAAV8-VRC07 on viral load were assessed. Viral Load is expressed in polymerase chain reaction (PCR) copies/mL, as reported by the Clinical Center serology lab. Values below the limit of quantification (\<20 copies/mL) or none detected were imputed to 10 copies/mL. Results are displayed as median(range).
| copies/mL | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Baseline, Week 0 (Visit 02) | 10 (NA to 23) | 10 (NA to NA) | 10 (NA to NA) |
| Week 12 (Visit 14) | 10 (NA to NA) | 10 (NA to NA) | 10 (NA to NA) |
| Week 44 (Visit 25) | 10 (NA to NA) | 10 (NA to 30) | 10 (NA to 29) |
The serum concentration of VRC07 at specified time intervals for 1 year after injection was determined, and if persistent, then every 6 months as long as there is detectable antibody in serum. The PK Singulex assay utilizes a microparticle-based immunoassay coupled with a fluorescent detection system to detect serum antibodies in the ng/mL range. Values below the limit of detection or none detected were set to 0.10 ng/mL; therefore, a value of 0.10 ng/mL means that the VRC07 concentration for that assay was below the limit of detection. Results are displayed as median(range).
| ng/mL | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Baseline, Week 0 (Visit 02) | 0.10 (0.10 to 20.26) | 0.10 (0.10 to 1.06) | 9.69 (0.10 to 13.62) |
| Week 6 (Visit 08) | 281.29 (71.06 to 401.70) | 216.71 (36.20 to 598.53) | 304.93 (37.04 to 1221.45) |
| Week 24 (Visit 20) | 374.63 (48.62 to 375.06) | 34.30 (5.85 to 413.50) | 908.01 (550.89 to 1265.14) |
| Week 52 (Visit 27) | 316.29 (127.49 to 350.34) | 9.24 (0.10 to 711.83) | 354.26 (39.39 to 2469.31) |
Collected over Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) visit. After the Day 56 visit, only serious AEs (SAEs) and new chronic medical conditions (NCMCs) that require ongoing medical management will be recorded through the last expected LTFU visit at Year 5 (260 weeks). After all data are collected, the data reported now for the Day 56 Time Frame will be updated to reflect all post-Day 56 SAEs and NCMCs.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | 1/3 (33.3%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Event | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| OverdoseInjury, poisoning and procedural complications | 0/3 | 1/3 | 0/4 |
| Event | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) |
|---|---|---|---|
| Administration site painGeneral disorders | 0/3 | 0/3 | 4/4 |
| Aspartate aminotransferase increasedInvestigations | 2/3 | 0/3 | 0/4 |
| Blood creatinine increasedInvestigations | 1/3 | 0/3 | 2/4 |
| HeadacheNervous system disorders | 0/3 | 0/3 | 2/4 |
| DiarrhoeaGastrointestinal disorders | 1/3 | 0/3 | 0/4 |
| Upper respiratory tract infectionInfections and infestations | 0/3 | 1/3 | 0/4 |
| Diabetes mellitusMetabolism and nutrition disorders | 0/3 | 1/3 | 0/4 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/3 | 1/3 | 1/4 |
Population included all enrolled participants.
| Age, Continuous(years) | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) | Total |
|---|---|---|---|---|
| Mean | 50.7 ± 12.9 | 34.7 ± 15.5 | 43.0 ± 12.8 | 42.8 ± 13.7 |
| Age, Customized(Participants) | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) | Total |
|---|---|---|---|---|
| 21-30 years | 0 | 2 | 0 | 2 |
| 31-40 years | 1 | 0 | 2 | 3 |
| 41-50 years | 0 | 0 | 0 | 0 |
| 51-60 years | 2 | 1 | 2 | 5 |
| Sex: Female, Male(Participants) | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 2 | 2 |
| Male | 3 | 3 | 2 | 8 |
| Race/Ethnicity, Customized(Participants) | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) | Total |
|---|---|---|---|---|
| Black or African American | 1 | 1 | 3 | 5 |
| White | 2 | 2 | 1 | 5 |
| Hispanic/Latino | 0 | 0 | 1 | 1 |
| Non-Hispanic/Latino | 3 | 3 | 3 | 9 |
| Weight (kg)(kg) | Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) | Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) | Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) | Total |
|---|---|---|---|---|
| Mean | 75.5 ± 8.6 | 74.5 ± 1.6 | 83.1 ± 8.8 | 78.2 ± 7.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) is not shared because it has limited value in a small phase 1 trial. We instead report non-IPD data as required in ClinicalTrials.gov.
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 ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Allergy and Infectious Diseases (NIAID) →