Actively Recruiting
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-07
200
Participants Needed
22
Research Sites
131 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
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
CONDITIONS
Official 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 clinical research site and be willing to follow the study schedule.
- Must understand study details and be willing to provide informed consent.
- Must agree not to join other clinical trials during this study.
- Must agree to receive HIV test results.
- Must be open to discussing HIV prevention.
- Must be assessed by clinic staff as having a low risk of HIV infection and commit to avoiding high-risk behaviors during the study.
- Must meet minimum hemoglobin levels based on gender and hormone therapy status.
- White Blood Cell counts should be within normal range or approved by site 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 must have a negative pregnancy test within 72 hours before starting.
- Must agree to use effective birth control from at least 21 days before joining until the end of the study.
- Must agree not to attempt pregnancy during the study.
You will not qualify if you...
- Blood transfusion within the last 120 days.
- Receipt of experimental treatments within the last 30 days.
- Weigh less than 35 kg (about 77 lbs).
- Plan to join another clinical trial during this study.
- Currently pregnant or breastfeeding.
- Received an HIV vaccine in a previous trial (unless placebo and approved).
- Had live vaccines within the last 14 days or non-live vaccines within the last 7 days.
- Received humanized or human monoclonal antibodies recently, except certain HIV antibodies more than 12 months ago.
- Had allergy shots within the last 14 days.
- Taken immunosuppressive drugs within the last 30 days, except some nasal sprays or mild skin treatments.
- History of serious allergic reactions to study product components.
- Received immunoglobulin within the last 60 days.
- Have autoimmune disease requiring immunosuppressive treatment unless mild and stable.
- Have immune system deficiency.
- Have significant medical conditions or abnormal labs that could affect health during study.
- Conditions making repeated injections or blood draws difficult.
- Conditions requiring active treatment posing risk during study.
- Conditions that could be confused with study product reactions.
- Medical, social, or occupational conditions interfering with study.
- Severe psychiatric conditions including ongoing suicide risk or recent attempts.
- Undergoing tuberculosis treatment.
- Severe asthma requiring frequent medication or emergency care.
- Diabetes mellitus (except well-controlled Type 2 or isolated gestational).
- Blood pressure above 160/110 mmHg.
- Diagnosed bleeding disorders.
- Active cancer unless reasonably assured cured or unlikely to recur during study.
- Seizures or seizure medications in past 3 years.
- History of severe allergic reactions like anaphylaxis not well-controlled for at least 5 years.
- 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
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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