Actively Recruiting
A Randomized, Double Blind, Controlled Phase 2 Trial Evaluating Safety, Tolerability, Pharmacokinetics, and Neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adults Without HIV
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-07
200
Participants Needed
22
Research Sites
34 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and neutralization of three broadly neutralizing monoclonal antibodies—VRC07-523LS, PGT121.414.LS, and PGDM1400LS—administered intravenously in adults without HIV. This phase 2, randomized, double-blind, controlled clinical trial aims to study these antibodies in about 200 participants over eighteen months to understand their effects and safety profile. Participants receive one of two dose combinations of the three antibodies given sequentially via intravenous infusion at the start of the study and again at six months. The first group receives 400mg of each antibody, while the second group receives higher doses: 3200mg of VRC07-523LS, 1600mg of PGT121.414.LS, and 1600mg of PGDM1400LS. These infusions are carefully monitored to assess how the antibodies behave in the body and their safety. During the study, participants undergo regular evaluations including monitoring for local and systemic adverse events at specific days, blood tests to track liver and kidney function, complete blood counts, and testing for antidrug antibodies. Researchers also measure pharmacokinetic parameters such as concentration and elimination of the antibodies over time. The total participation spans 18 months, with ongoing safety assessments and early termination options if needed.
CONDITIONS
Brief Title
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 18 and 65 years old.
- Must have access to a participating research site and agree to follow the study schedule.
- Must understand the study and be willing to give informed consent.
- Must agree not to join other clinical trials during this study.
- Must be willing to receive HIV test results.
- Must be open to discussing HIV prevention.
- Assessed as having low risk for HIV and committed to avoiding high-risk behaviors during the study.
- Must meet minimum hemoglobin levels based on gender and hormone therapy status.
- White blood cell counts must be within normal range or approved by a clinician.
- Platelet count must be at least 100,000 cells/mm³.
- Alanine aminotransferase (ALT) must be less than 5 times the upper normal limit.
- Creatinine must be less than 1.8 times the upper normal limit or less than 1.5 times baseline.
- Must test negative for HIV-1 and HIV-2.
- Urine protein must be negative or trace.
- Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting.
- Must agree to use effective birth control from 21 days before joining until study end.
- Must agree not to try to become pregnant during the study.
You will not qualify if you...
- Cannot have had a blood transfusion within the last 120 days.
- Cannot have received experimental treatments within the last 30 days.
- Cannot weigh less than 35 kg (about 77 lbs).
- Cannot plan to join another clinical trial during this study.
- Cannot be pregnant or breastfeeding.
- Cannot have received an HIV vaccine in a previous trial unless placebo with approval.
- Cannot have had live vaccines within 14 days or non-live vaccines within 7 days.
- Cannot have had humanized or human monoclonal antibodies recently, except certain HIV antibodies over 12 months ago.
- Cannot have had allergy shots within the last 14 days.
- Cannot have taken immunosuppressive drugs in the last 30 days except some nasal sprays or mild skin treatments.
- Cannot have serious allergic reactions to study product components.
- Cannot have received immunoglobulin within the last 60 days.
- Cannot have autoimmune diseases requiring immunosuppressive treatment unless mild and stable.
- Cannot have immune system deficiencies.
- Cannot have significant medical conditions or abnormal labs that may affect health during the study.
- Cannot have conditions that make repeated injections or blood draws difficult.
- Cannot have conditions requiring active medical treatment posing risk during the study.
- Cannot have conditions that could mimic reactions to the study product.
- Cannot have medical, social, or occupational conditions interfering with the study.
- Cannot have severe psychiatric conditions or recent suicide risk.
- Cannot be undergoing tuberculosis treatment.
- Cannot have severe asthma needing frequent medication or emergency care.
- Cannot have diabetes mellitus (except well-controlled Type 2 or isolated gestational diabetes).
- Blood pressure must be below 160/110 mmHg.
- Cannot have diagnosed bleeding disorders.
- Cannot have active cancer unless reasonable assurance of sustained cure or unlikely recurrence.
- Cannot have seizures or seizure medications in past 3 years.
- Cannot have severe allergic reactions unless well-controlled for 5 years.
- Cannot have acute or unstable hepatitis B or C; stable chronic cases may be considered.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive intravenous infusions of broadly neutralizing monoclonal antibodies at Month 0 and Month 6.
2 infusion visits (in-person) at Month 0 and Month 6
Duration - Up to 48 weeks after first infusion
Participants are monitored for safety, tolerability, and pharmacokinetics with clinical assessments and blood tests.
Multiple visits at Days 1, 4, 7, 29, 57, 169, 173, 225, and 337 for assessments and blood draws
Trial Site Locations
Total: 22 locations
1
Alabama CRA (Site #31788)
Birmingham, Alabama, United States, 35222
Actively Recruiting
2
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
Actively Recruiting
3
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States, 30030
Actively Recruiting
4
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States, 02115-6110
Actively Recruiting
5
Fenway Health
Boston, Massachusetts, United States, 02215-4302
Actively Recruiting
6
BIDMC VCRS (Site ID# 32077)
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Columbia P&S CRS
New York, New York, United States, 10032
Actively Recruiting
8
University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
Rochester, New York, United States, 14642
Actively Recruiting
9
Chapel Hill CRS (Site #3201)
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
10
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
University of Pittsburgh CRS (Site 1001)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Seattle Vaccine and Prevention CRS (Site ID# 30331)
Seattle, Washington, United States, 98104
Actively Recruiting
14
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil, 21040-360
Actively Recruiting
15
ACSA CRS
Iquitos, Maynas, Peru, 1
Not Yet Recruiting
16
CITBM CRS (Site ID 31970)
Callao, Peru, 15081
Actively Recruiting
17
Via Libre (Site ID 31909)
Lima, Peru, 15001
Actively Recruiting
18
San Miguel CRS (Site #11302)
Lima, Peru, 32-15088
Actively Recruiting
19
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gaunteng, South Africa, 1862
Not Yet Recruiting
20
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa, 4030
Not Yet Recruiting
21
Setshaba Research Centre
Soshanguve-H, Soshanguve, South Africa, 0152
Not Yet Recruiting
22
Groote Schuur HIV CRS
Cape Town, Western Cape, South Africa, 7925
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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