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Cancer Vaccine

Vaccines for HIV Prevention

Phase 1

Waitlist Available

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 through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test two different vaccines in adults without HIV to see if they are safe and well-tolerated. The study will also explore whether the vaccines can help in the development of B-cell

Who is the study for?

This trial is for adults without HIV who are interested in testing new vaccine regimens aimed at preventing HIV/AIDS. Participants must attend scheduled visits and keep a daily eDiary of symptoms.

What is being tested?

The study tests the safety and immune response to two experimental vaccines (16055 NFL delta Gly4 Env protein trimer and Trimer 4571) with an adjuvant, plus a viral particle booster (Ad4-Env145NFL).

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain, or allergic responses to components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Local reactogenicity signs and symptoms

Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.)

Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc)

+2 more

Secondary study objectives

Magnitude of serum IgG binding antibodies

Magnitude of serum antibody neutralization of HIV-1 strains

Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086)

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment 3Experimental Treatment3 Interventions

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.27 mL each) at months 0 and 2. Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.2 mL each) at month 4. Ad4-Env145NFL, 5 x 108 vp to be administered IN (0.07 mL into 1 nostril) at months 8 and 12.

Group II: Treatment 2Experimental Treatment3 Interventions

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.27 mL each) at months 0 and 2. Ad4-Env145NFL, 5 x 108 viral particles (vp) to be administered intranasally (IN) (0.07 mL into 1 nostril) at month 4. Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.2 mL each) at months 8 and 12.

Group III: Treatment 1Experimental Treatment1 Intervention

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate intramuscular (IM) injections (0.27 mL each) at months 0, 2, 4, 8, and 12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trimer 4571

2020

Completed Phase 1

~130

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