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Clinical Trial Summary

The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate. The secondary objectives of the study are: - To describe the immunogenicity of the PrEP regimen in each group - To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination - To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group - To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group


Clinical Trial Description

Study duration per participant is approximately 403 to 436 days ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03700242
Study type Interventional
Source Sanofi
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Status Completed
Phase Phase 3
Start date September 26, 2018
Completion date April 8, 2020