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Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine

HIV Clinical Trial

Official title:
Phase 1 Randomised, Single-centre, Observer-blind, Placebo-controlled Trial of Safety and Immunogenicity of EN41-UGR7C HIV Vaccine Candidate Administered Intramuscularly in Healthy Female Volunteers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01827397
Study type Interventional
Source PX'Therapeutics
Contact
Status Completed
Phase Phase 1
Start date April 2013
Completion date February 2014
View Details
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