drugset / Trial / NCT05470400

A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults

NCT05470400

RandomizedSequentialOpen-labelPrevention

Summary

This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.

Timeline

Start
2022-08-15
Primary completion
2024-01-24
Completion
2024-01-24

Drugs

EvaluationDrugModalityDoseRoute
Subject FP conjugate vaccine Unknown 25 ug Intramuscular
Subject FP conjugate vaccine Unknown 200 ug Intramuscular
Subject Trimer 4571 Vaccine 100 ug Intramuscular
Subject Trimer 4571 Vaccine 200 ug Intramuscular
Subject Trimer 6931 Unknown 100 ug Intramuscular
Subject Trimer 6931 Unknown 200 ug Intramuscular