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Aeras 402 Vaccine Protocol 018

Aeras 402 Vaccine Protocol 018

Title:

Phase I Double-blind Randomized Controlled Dose Escalation Study to Evaluate Safety and Immunogenicity of AERAS-402 in BCG vaccinated, HIV-negative
Infants at Least 6 Months of Age without Evidence of Tuberculosis.

Study description:

The objective of the study is to test the safety and immunogenicity of the Aeras 402 vaccine in infants.

The study used a double-blind, randomised, placebo-controlled dose escalation methodology, amongst 54 BCG-vaccinated, HIV negative infants between 6-12 months of age.

The study timeline is between 2009 and 2010.

Principal Investigator: Michele Tameris

Partner: Aeras Global TB Vaccine Foundation