Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine

Summary

The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the immunisation is to induce mucosal and systemic binding and neutralizing antibodies against HIV in order to block the virus on the mucosal surface and neutralise the viral particles that may eventually succeed in crossing the mucosal barrier. This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in humans. Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but its ability to induce meaningful protection against HIV will not be known before Phase 3 efficacy trials are completed, as correlates of protection against HIV are not yet clearly defined. Consequently, there is no direct benefit to volunteers. They will be reimbursed for their time and travel.

Timeline

Start

2013-04

Primary completion

2013-11

Completion

2014-02

Drugs

Indications