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 - Trial NCT06267872
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.
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Study Focus
Sponsor & Location
National Institute of Allergy and Infectious Diseases (NIAID)
Timeline & Enrollment
Phase 1
May 31, 2024
Jul 11, 2026
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
Data Source
ClinicalTrials.gov
NCT06267872
Non-Device Trial