A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV - Trial NCT06033209

Timeline & Enrollment

Primary Outcome

Local reactogenicity signs and symptoms (solicited adverse events) will be collected,Systemic reactogenicity signs and symptoms (solicited adverse events) will be collected,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 AESIs leading to early participant withdrawal or permanent discontinuation,Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation,Comparison of number of reported/assessed local and systemic reactogenicity, SAE's and AESI's and medically attended adverse events at increasing doses of adjuvant at constant dose of N332-GT5 gp140,Frequency of BG18 epitope-specific B cells as determined by flow cytometry,Proportion of participants with BG18-class IgG memory B cells in peripheral blood mononuclear cell (PBMCs), measured by antigen-specific B-cell sorting, B-cell receptor (BCR) sequencing, and bioinformatic analysis,Frequency of BG18-class B cells among IgG memory B cells in PBMCs, measured by antigen-specific B-cell sorting, BCR sequencing, and bioinformatic analysis

Summary

HVTN 144 is a phase 1 clinical trial to being conducted to evaluate the safety and
 immunogenicity of an HIV envelope trimer, N332-GT5 gp140, adjuvanted with saponin/MPLA
 nanoparticles (SMNP) in adult participants without HIV. The study aims to evaluate the safety
 and tolerability of N332-GT5 gp140 adjuvanted with SMNP in adult volunteers without HIV and
 in overall good health, including identifying a safe and tolerable dose, route, and schedule
 of administration of the novel adjuvant SMNP. The study also aims to evaluate the induction
 of BG18-class immunoglobulin G (IgG) B-cell responses in memory B cells by the study regimens
 and compare the responses between the different groups.
 
 HVTN 144 will be conducted in 2 parts with 84 volunteers without HIV and in overall good
 health, aged 18 to 55 years. The study duration is 22 months which includes 8 months for
 enrollment, planned safety holds, follow-up, and Adverse Event of Special Interest (AESI)
 health contact 1 year after last vaccination.

ICD-10 Classifications