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Cancer Vaccine

Treatment 1 for HIV/AIDS

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 through study completion, an average of 1 year
Awards & highlights

Study 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.Check my eligibility
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).See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.)
Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation
+7 more
Secondary outcome measures
Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM)
Flow cytometry analysis of the frequency of Env-specific IgG+ B cells
Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination
+16 more

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,277 Previous Clinical Trials
5,487,403 Total Patients Enrolled
~33 spots leftby Nov 2026
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