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. - Trial NCT06332339
Access comprehensive clinical trial information for NCT06332339 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) and is currently Recruiting. The study focuses on HIV. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
National Institute of Allergy and Infectious Diseases (NIAID)
Timeline & Enrollment
Phase 1
Mar 15, 2024
Nov 11, 2026
Primary Outcome
Local reactogenicity signs and symptoms,Systemic reactogenicity signs and symptoms,Number of adverse events (AEs) reported for 30 days after receipt of any study product,Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation,Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation,Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation,Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation,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),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.),Response Rate 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.)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06332339
Non-Device Trial