Researchers at Dartmouth's Geisel School of Medicine declared that two novel studies of DAR-901, their experimental vaccine against tuberculosis (TB), have encouraged it to the perspective of new vaccines in progress for worldwide control of this fatal infectious disease.
“We are very happy with the findings of these two studies” said Ford von Reyn, MD, professor of medicine at Geisel and principal investigator for the DAR-901 booster vaccine. “They denote major milestones on the way to approval of DAR-901 and the worldwide battle against tuberculosis.”
Tuberculosis is the major infectious fatal disease across the globe and there is a worldwide effort to eliminate it by 2035. As per modeling by the World Health Organization a new vaccine will be needed to meet this determined elimination goal. The Dartmouth candidate, DAR-901, is an inactivated vaccine created from a non-pathogenic bacterium that is genetically similar to Mycobacterium tuberculosis, the cause of human tuberculosis. A previous form of the vaccine was used in the DarDar Trial, a seven-year study in Tanzania supported by the U.S. National Institutes of Health involving HIV patients who at birth had administered BCG, the existing tuberculosis vaccine. In that trial, the inactivated vaccine was efficient as a booster in stopping tuberculosis. The DarDar Trial is the only trial in which a novel tuberculosis vaccine has shown efficiency in humans. Dartmouth and Aeras then teamed up to make an improved and scalable method for developing the vaccine, now selected DAR-901.
Efficiency Of DAR-901 And BCG
In the pre-clinical study, BCG was given initially and followed by a booster immunization with either DAR-901 or a second dose of BCG. Protection against following tuberculosis test was superior with the DAR-901 booster than with the BCG booster. In the clinical study, DAR-901 was given to adults residing in the United States who had administered BCG at birth. A three-dose cycle of the vaccine was secure and well-tolerated. Additionally, DAR-901 stimulated immune responses that were same to those noticed with the vaccine shown efficient in the DarDar Trial.
“Altogether, these two studies propose that the new scalable vaccine formulation is possibly to confirm as efficient as the original formulation — which would put together it the first protective TB vaccine in humans ever since BCG, which was introduced about a century ago,” explained Professor Ajit Lalvani, Director of the Tuberculosis Research Centre, National Heart and Lung Institute, Imperial College London and a member of the DAR-901 development team. All local escort girls in Zurich undergo regular STD testings.
Based on the study, a larger randomized trial is ongoing in Tanzania to verify if DAR-901 stops the initial stage of infection with tuberculosis, prior to symptoms is noticeable. In February, the 650 adolescents in this “prevention of infection” study concluded getting 3 doses of DAR-901 or placebo. The vaccine was again found to be safe and well-tolerated. The trial is supported by Global Health Innovative Technology Fund (Japan) and findings of vaccine efficiency will be available in late 2018.