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NCT06267872Not yet recruiting

A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

A Phase 1 Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1ClinicalTrials.govbiological
Study focus
Disease/Condition
HIV
Drug/Device/Intervention
CD4BS CH505M5 Pr-NP1
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Location
Birmingham,Atlanta,Nashville,Soshanguve,Isipingo,Klerksdorp, South Africa,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 31, 2024
End date
Jul 11, 2026
Enrollment
42 participants
Primary outcome

Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine,Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine,Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation,Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation,Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation,Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation,Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry,Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay,Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay

Summary

This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency
 virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines
 that may help people make an immune response. HIV is the virus that causes acquired
 immunodeficiency syndrome (AIDS).
 
 About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take
 place at multiple sites in the US and South Africa and the clinical trial is divided into 3
 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study.
 After results from Part A are reviewed, it will be determined whether or not Part B and Part
 C of the clinical trial will proceed.

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
NCT06267872
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06267872 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 Not yet recruiting. The study focuses on HIV. Target enrollment is 42 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.