A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

Last updated: March 24, 2025
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Active - Recruiting

Phase

2

Condition

Hiv

Treatment

PGT121.414.LS 400mg

VRC07-523LS 400mg

PGDM1400LS 1600mg

Clinical Study ID

NCT06812494
HVTN 206/HPTN 114
39137
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants need to be between 18 and 65 years old.

  • Participants must have access to a participating clinical research site and bewilling to follow the study schedule.

  • Participants should understand the study details and be willing to give informedconsent.

  • Participants must agree not to join any other clinical trials until they finish thisstudy.

  • 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, andparticipants must commit to avoiding high-risk behaviors during the study.

  • Hemoglobin: Participant meets minimum levels depending on gender and hormone therapystatus.

  • White Blood Cells (WBC): Should be within the normal range or approved by a siteclinician.

  • 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 yourbaseline 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 72hours before starting the study.

  • Participants must agree to use effective birth control from at least 21 days beforejoining the study until the end of the study.

  • Participants must agree not to try to become pregnant through any method during thestudy.

Exclusion

Exclusion Criteria:

  • Participants cannot have had a blood transfusion within the last 120 days.

  • 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 wasa placebo, subject to Protocol Safety Review Team's approval).

  • Participants cannot have had any live vaccines within the last 14 days or non-livevaccines 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, withsome exceptions like nasal sprays or mild skin treatments.

  • Participants cannot participate if they have had serious allergic reactions to thecomponents of the study product.

  • Participants cannot have received immunoglobulin within the last 60 days.

  • Participants cannot have an autoimmune disease that requires immunosuppressivetreatment, unless it's mild and stable.

  • Participants cannot have an immune system deficiency.

  • Participants cannot have any significant medical condition or abnormal lab resultsthat could impact their health during the study.

  • Participants cannot have conditions that make repeated injections or blood drawsdifficult.

  • Participants cannot have conditions requiring active medical treatment that couldpose a risk during the study.

  • Participants cannot have conditions that could be confused with reactions to thestudy product.

  • Participants cannot have medical, social, or occupational conditions that wouldinterfere with the study.

  • Participants cannot have severe psychiatric conditions, like ongoing risk of suicideor recent history of suicide attempts.

  • Participants cannot be undergoing treatment for tuberculosis.

  • Participants cannot have severe asthma that requires frequent medication oremergency care.

  • Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or anisolated 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'sestimation, they have a reasonable assurance of sustained cure, or are unlikely toexperience recurrence of malignancy during the period of the study

  • Participants cannot have had seizures or taken seizure medications in the past 3years.

  • 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 chroniccases may be considered.

Study Design

Total Participants: 200
Treatment Group(s): 6
Primary Treatment: PGT121.414.LS 400mg
Phase: 2
Study Start date:
March 07, 2025
Estimated Completion Date:
September 15, 2027

Connect with a study center

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

    Rio De Janeiro, 21040-360
    Brazil

    Site Not Available

  • ACSA CRS

    Iquitos, Maynas 1
    Peru

    Site Not Available

  • Citbm Crs

    Callao, 15081
    Peru

    Site Not Available

  • Via Libre

    Lima, 15001
    Peru

    Site Not Available

  • Perinatal HIV Research Unit (PHRU)

    Johannesburg, Gaunteng 1862
    South Africa

    Site Not Available

  • Chatsworth CRS

    Chatsworth, KwaZulu-Natal 4030
    South Africa

    Site Not Available

  • Setshaba Research Centre

    Soshanguve - H, Soshanguve 0152
    South Africa

    Site Not Available

  • Groote Schuur HIV CRS

    Cape Town, Western Cape Province 7925
    South Africa

    Site Not Available

  • Bridge HIV, San Francisco Department of Public Health

    San Francisco, California 94102
    United States

    Active - Recruiting

  • The Hope Clinic of the Emory Vaccine Research Center; Emory University

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Fenway Health

    Boston, Massachusetts 02215-4302
    United States

    Site Not Available

  • Chapel Hill CRS

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

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