Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects

Summary

This study is designed to investigate the safety and efficacy of a newly developed vaccine against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic adverse reactions, investigations of blood and urine, and physical exam including vital sign measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.

Timeline

Start

2009-11

Primary completion

2010-09

Completion

2010-09

Publications

• Leroux-Roels G, Maes C, Clement F, van Engelenburg F, van den Dobbelsteen M, Adler M, Amacker M, Lopalco L, Bomsel M, Chalifour A, Fleury S. Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes. PLoS One. 2013;8(2):e55438. doi: 10.1371/journal.pone.0055438. Epub 2013 Feb 20.

Drugs

Indications

No indication recorded.