A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
NCT ID: NCT06812494
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-03-07
2027-09-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1 (400 mg + 400 mg +400 mg)
VRC07-523LS 400mg + PGT121.414.LS 400mg + PGDM1400LS 400mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
VRC07-523LS 400mg
Intravenous infusion (IV)
PGT121.414.LS 400mg
IV infusion
PGDM1400LS 400mg
IV infusion
Group 2 (3200 mg + 1600 mg +1600 mg)
VRC07-523LS 3200mg + PGT121.414.LS 1600mg + PGDM1400LS 1600mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
VRC07-523LS 3200mg
IV infusion
PGT121.414.LS 1600mg
IV infusion
PGDM1400LS 1600mg
IV infusion
Interventions
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VRC07-523LS 400mg
Intravenous infusion (IV)
PGT121.414.LS 400mg
IV infusion
PGDM1400LS 400mg
IV infusion
VRC07-523LS 3200mg
IV infusion
PGT121.414.LS 1600mg
IV infusion
PGDM1400LS 1600mg
IV infusion
Eligibility Criteria
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Inclusion Criteria
* Participants must have access to a participating clinical research site and be willing to follow the study schedule.
* Participants should understand the study details and be willing to give informed consent.
* Participants must agree not to join any other clinical trials until they finish this study.
* Participants must be willing to receive HIV test results.
* Participants should be open to discussing HIV prevention.
* Clinic staff should assess participants as having a low risk of getting HIV, and participants must commit to avoiding high-risk behaviors during the study.
* Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status.
* White Blood Cells (WBC): Should be within the normal range or approved by a site clinician.
* Platelets: At least 100,000 cells/mm³.
* Alanine aminotransferase (ALT): Less than 5 times the upper normal limit.
* Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times your baseline level.
* Participants must test negative for HIV-1 and HIV-2.
* Participants urine protein must be negative or trace.
Reproductive Status:
* Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting the study.
* Participants must agree to use effective birth control from at least 21 days before joining the study until the end of the study.
* Participants must agree not to try to become pregnant through any method during the study.
Exclusion Criteria
* Participants cannot have received experimental treatments within the last 30 days.
* Participants cannot weigh less than 35 kg (about 77 lbs).
* Participants cannot plan to join another clinical trial during this study.
* Participants cannot be pregnant or breastfeeding.
* Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval).
* Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days.
* Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago.
* Participants cannot have had allergy shots within the last 14 days.
* Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments.
* Participants cannot participate if they have had serious allergic reactions to the components of the study product.
* Participants cannot have received immunoglobulin within the last 60 days.
* Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable.
* Participants cannot have an immune system deficiency.
* Participants cannot have any significant medical condition or abnormal lab results that could impact their health during the study.
* Participants cannot have conditions that make repeated injections or blood draws difficult.
* Participants cannot have conditions requiring active medical treatment that could pose a risk during the study.
* Participants cannot have conditions that could be confused with reactions to the study product.
* Participants cannot have medical, social, or occupational conditions that would interfere with the study.
* Participants cannot have severe psychiatric conditions, like ongoing risk of suicide or recent history of suicide attempts.
* Participants cannot be undergoing treatment for tuberculosis.
* Participants cannot have severe asthma that requires frequent medication or emergency care.
* Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary).
* Participants blood pressure must be below 160/110 mmHg.
* Participants cannot have any diagnosed bleeding disorders.
* Participants cannot have active cancer but may be eligible if, in the investigator's estimation, they have a reasonable assurance of sustained cure, or are unlikely to experience recurrence of malignancy during the period of the study
* Participants cannot have had seizures or taken seizure medications in the past 3 years.
* Participants cannot have a history of severe allergic reactions like anaphylaxis, unless it has been well-controlled for at least 5 years.
* Participants cannot have acute or unstable hepatitis B or C, but stable chronic cases may be considered.
18 Years
65 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Department of Health and Human Services
FED
Dale and Betty Bumpers Vaccine Research Center (VRC)
UNKNOWN
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Locations
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Alabama CRA (Site #31788)
Birmingham, Alabama, United States
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health
Boston, Massachusetts, United States
BIDMC VCRS (Site ID# 32077)
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
Chapel Hill CRS (Site #3201)
Chapel Hill, North Carolina, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS (Site 1001)
Pittsburgh, Pennsylvania, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS (Site ID# 30331)
Seattle, Washington, United States
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, , Brazil
ACSA CRS
Iquitos, Maynas, Peru
CITBM CRS (Site ID 31970)
Callao, , Peru
Via Libre (Site ID 31909)
Lima, , Peru
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gaunteng, South Africa
Chatsworth CRS
Chatsworth, KwaZulu-Natal, South Africa
Setshaba Research Centre
Soshanguve-H, Soshanguve, South Africa
Groote Schuur HIV CRS
Cape Town, Western Cape, South Africa
Countries
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Facility Contacts
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Heather Logan, ANP
Role: primary
Emily Schaeffer
Role: primary
Emily Claire Osborne
Role: primary
Jose Licona
Role: primary
Kevin Smith
Role: primary
Audrey Nathanson, RN
Role: primary
Anyelina Cantos
Role: primary
Erin Hoffman
Role: primary
Debora Dunbar
Role: primary
Stacey Edick
Role: primary
Shonda Sumner, B.S.N.
Role: primary
Jennifer Han
Role: primary
Brenda Hoagland
Role: primary
Ana Rimachi
Role: primary
Fanny Rosas Benancio
Role: primary
Carlos Anton
Role: primary
Ravindre Panchia
Role: primary
Kerusha Chunderduri
Role: primary
Enough Mbatsane
Role: primary
Doerieyah Reynolds
Role: primary
Related Links
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Other Identifiers
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39137
Identifier Type: OTHER
Identifier Source: secondary_id
HVTN 206/HPTN 114
Identifier Type: -
Identifier Source: org_study_id