HIV Vaccine for Human Immunodeficiency Virus

Phase 1

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following any receipt of study product

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a potential HIV vaccine to see if it's safe and effective. It's the first of its kind.

Who is the study for?

This trial is for people aged 18-55 living with HIV on stable ART (antiretroviral therapy) for at least 48 weeks, with undetectable viral load and good immune health. They must be in overall good health, not pregnant or planning pregnancy, willing to use contraception, and able to complete the study. Those already in another trial need special approval.

What is being tested?

The trial tests a new vaccine candidate (426c.Mod.Core-C4b) combined with an adjuvant (3M-052-AF+Alum) designed to stimulate immune responses in HIV-positive individuals. It's a phase 1 multicenter controlled interventional study assessing safety and immune response.

What are the potential side effects?

Potential side effects are not specified but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic reactions. Since it's a phase 1 trial, part of its purpose is to identify any side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following any receipt of study product

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following any receipt of study product

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following any receipt of study product for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of Env-specific and CD4-bs-specific B cells

Frequency of VRC01-class BCR sequences of isolated CD4-bs B cells

Frequency of VRC01-class BCR sequences of isolated CD4-bs B cells, prior to ATI

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (No ATI) ControlExperimental Treatment2 Interventions

Group 2 transitions from Schedule 1 into Schedule 4, "Follow-up on ART," at the Week 14 visit, and remains on Schedule 4 through study week 64.

Group II: Group 1 (ATI)Experimental Treatment2 Interventions

Group 1 will receive 2 doses of the vaccine at Week 0 and 12. Group 1 will transition to Schedule 2 at the Week 14 visit. The Schedule 2 "ATI with Monitoring" phase can last for 24 weeks OR until any antiretroviral therapy (ART) re-initiation criteria are met, OR the ATI can continue longer with the approval of the Protocol Safety Review Team (PSRT) and the participant's primary HIV healthcare provider. Group 1 will transition to Schedule 3, the "Follow-up on ART restart" phase that lasts until study week 64, regardless of the point where it begins.

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