Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06332339
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 16055 NFL delta Gly4 trimer — BIOLOGICAL
    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)
  • Trimer 4571 — BIOLOGICAL
    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)
  • Ad4-Env145NFL, 5 x 108 viral particles (vp) — BIOLOGICAL
    to be administered intranasally (IN) (0.07 mL into 1 nostril)

Study Details

The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV. The main question\[s\] it aims to answer are: * Are these vaccine regimens safe and well tolerated? * Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses? Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary.

Key Dates

First listed
Mar 27, 2024
Start date
Mar 15, 2024
Status verified
Nov 2024
Primary completion
Nov 11, 2026
Completion
Nov 11, 2026

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment 1
    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.
  • Experimental: Treatment 2
    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.
  • Experimental: Treatment 3
    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.

Primary Outcome Measure

Local reactogenicity signs and symptoms [ Time Frame: 2 weeks following any injection ]

Locations (6)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35222-
The Hope Clinic of the Emory Vaccine Center CRS Site# 31440DecaturGeorgia30030-
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)BostonMassachusetts02115-
Columbia P&S CRSNew YorkNew York10032-
University of Rochester HIV/AIDS CTURochesterNew York14642-
University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials UnitPhiladelphiaPennsylvania19104-

Find similar trials in Birmingham, AL

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Alabama CRS· Birmingham, ALThe Hope Clinic of the Emory Vaccine Center CRS· Decatur, GABrigham and Women's Hospital Vaccine CRS (BWH VCRS)· Boston, MAColumbia P&S CRS· New York, NYUniversity of Rochester HIV/AIDS CTU· Rochester, NYUniversity of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit· Philadelphia, PA

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