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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Enrolling; Phase 2

Conditions: HIV

Treatments: Biological: PGDM1400LS 1600mg; Biological: PGDM1400LS 400mg; Biological: VRC07-523LS 3200mg; Biological: PGT121.414.LS 1600mg; Biological: VRC07-523LS 400mg; Biological: PGT121.414.LS 400mg

Study type: Interventional

Funder types: Other U.S. Federal agency; Other; NIH

Identifiers

NCT06812494

HVTN 206/HPTN 114

39137

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Group 1 (400 mg + 400 mg +400 mg)

Experimental group

Description:

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

Treatment:

Biological: PGT121.414.LS 400mg

Biological: VRC07-523LS 400mg

Biological: PGDM1400LS 400mg

Group 2 (3200 mg + 1600 mg +1600 mg)

Experimental group

Description:

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

Treatment:

Biological: PGT121.414.LS 1600mg

Biological: VRC07-523LS 3200mg

Biological: PGDM1400LS 1600mg