TBRU’s mission for clinical trials includes potential interventions such as new vaccines, prophylactics or therapeutic regimens, using developed surrogate markers of M. tuberculosis infection, tuberculosis progression and/or host protection to validate the usefulness of these markers in clinical trials and evaluate safety, reactogenicity and efficacy of new regimens. This includes Phase I, and II clinical trials using potential new surrogate markers, evaluation of new assays for the rapid diagnosis of tuberculosis and drug susceptibility testing, and developing and implementing strategies for long-term follow-up. In addition investigators work closely with the trials sites and staff to also support TBRU pilot immunological and microbiological studies focusing on novel surrogate markers of response to TB treatment and correlates of protective immunity.
TBRU currently has three primary clinical trial sites located at Mulago Hospital, Makerere University, Kampala, the South African Tuberculosis Vaccine Initiative, University of Cape Town, Cape Town, South Africa (including the SATVI Brewelskloof Tuberculosis Hospital, Worcester, South Africa), and TASK Applied Sciences, Cape Town, South Africa.
Organization and Operation
New clinical trials are identified, considered, and developed with the Scientific Working Groups and the NIH sponsor. Dr. Henry Boom and Dr. John L. Johnson, at CWRU lead these new initiatives and development as indicated for TBRU clinical trials. Once a specific trial is determined for TBRU, a protocol team of investigators and staff from CWRU, the clinical field site, as well as additional TBRU investigators are convened for development and implementation of the final trial protocol. Clinical trials protocol teams work closely with the sponsor office during the development period and thereafter to assure all regulatory issues are appropriately addressed for these new studies.
Active and completed Clinical Trials
Below is a listing of active and completed clinical trials conducted by TBRU. For further details on these trials, please click the links provided in the short study title.