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NCT06332339Recruiting

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.

A First-in-human Phase 1 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
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
HIV
Drug/Device/Intervention
16055 NFL delta Gly4 trimer
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Location
Birmingham,Atlanta,Boston,New York,Rochester,Philadelphia, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 15, 2024
End date
Nov 11, 2026
Enrollment
50 participants
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
Human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHIV disease resulting in other viral infectionsUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other specified diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06332339
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.