A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS‑404 When Administered as a Single Adjuvant Amount with Different Antigen Amounts in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection.
The objective of the study is to test the safety and immunogenicity of the Aeras 404 vaccine.
The study used a Randomised, placebo-controlled, double-blind trial. 4 groups of 10 healthy BCG vaccinated, HIV negative adult participants , with an antigen dose-escalation after each group. Each participant will receive 2 vaccinations of the same dose 56 days apart.
The study timeline is between 2008 and 2010.
Principal Investigators: Hassan Mahomed Partner: Aeras Global TB Vaccine Foundation