NCT06332339View on ClinicalTrials.gov

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.

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

November 11, 2026

Study Completion Date

November 11, 2026

Conditions
HIV
Interventions
BIOLOGICAL

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)

BIOLOGICAL

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)

BIOLOGICAL

Ad4-Env145NFL, 5 x 108 viral particles (vp)

to be administered intranasally (IN) (0.07 mL into 1 nostril)

Trial Locations (6)

10032

Columbia P&S CRS, New York

14642

University of Rochester HIV/AIDS CTU, Rochester

19104

University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit, Philadelphia

30030

The Hope Clinic of the Emory Vaccine Center CRS Site# 31440, Decatur

35222

Alabama CRS, Birmingham

02115

Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT06332339 - 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. | Biotech Hunter | Biotech Hunter