Aeras has announced encouraging findings from its Phase II trial that examined Bacille Calmette-Guerin (BCG) revaccination in combination with H4:IC31 vaccination for treatment of tuberculosis (TB).
The trial was designed to examine BCG and H4:IC31 for safety, immunogenicity and their ability to prevent initial and sustained TB infections among healthy adolescents.
A total of 990 HIV-negative, healthy adolescents aged between 12 and 17 years who had been vaccinated as infants with BCG were enrolled for the randomised, placebo-controlled prevention-of-infection trial.
During the trial, the subjects were randomised equally into three study groups including placebo, H4:IC31, or BCG revaccination.
All subjects were screened to ensure they were not infected with Mycobacterium tuberculosis (Mtb) before receiving vaccination in the study.
In the beginning of the proof-of-concept study, statistical significance was set at one-sided p<0.1 to favour the risk of observing a false positive efficacy signal rather than a false negative.
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Findings from the trial have revealed that both vaccines appeared to be safe and produced an immune response in the participants.
The most common vaccine-related adverse event reported in the event was injection site swelling in BCG revaccinated participants, which is typical for BCG vaccination. Other than that, the study did not find any vaccine-related adverse events.
The trial was carried out at the University of Cape Town’s South African Tuberculosis Vaccine Initiative (SATVI) and at the Emavundleni Research Centre, which is a part of Desmond Tutu HIV Centre).
University of Cape Town SATVI director and principal investigator of the study Mark Hatherill said: “While neither vaccine proved to be statistically significant in preventing an initial TB infection, we are extremely encouraged by the signals observed for both vaccines in preventing sustained TB infections.
“We believe the results from this novel trial design will provide significant scientific benefit to the field in understanding TB infection, and based on this positive signal, we look forward to testing the potential of such vaccines to prevent TB disease among uninfected adolescents in a larger, more traditional prevention-of-disease clinical trial.”
H4:IC31 is an investigative subunit vaccine currently under development by a partnership of Aeras and Sanofi Pasteur, the vaccines business of Sanofi, and Statens Serum Institut.
BCG is a licensed tuberculosis vaccine available globally.