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The Safety and Immunogenicity of a Potential HIV Vaccine

HIV Infections Clinical Trial

Official title:
A Phase 1 Open-Labelled Trial to Evaluate the Safety and Immunogenicity of CN54gp140 in HIV-Uninfected, Healthy Volunteers

Clinical Trial Summary

The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous formulation (GLA-AF).

We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response stimulated by the vaccine) when it is given in two different dose regimens:

Group A: vaccinations at Months 0, 1, 2 and 6Íž and Group B: vaccinations at Months 0, 1, 2 and 12.

Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5 micrograms of GLA-AF.

We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the vaccine by monitoring the occurrence of adverse events in the participants. We will assess the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood and in genital mucosal secretion samples.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01966900
Study type Interventional
Source Imperial College London
Contact
Status Completed
Phase Phase 1
Start date October 2013
Completion date November 2015
View Details
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