THE newly-upgraded Isango Lethemba TB Research Unit, within the Jose Pearson Hospital in Gqeberha, will host the commencement of a significant phase 3 clinical trial, sponsored by the Bill and Melinda Gates Medical Research Institute (Gates MRI).
The trial will test the efficacy of the M72/AS01E tuberculosis (TB) vaccine candidate, and this initiative is deemed especially vital, given that the Eastern Cape has the highest incidence of TB in the country.
The M72/AS01E TB vaccine candidate aims at preventing pulmonary TB in adolescents and adults, the most common form of the disease.
If successful, this would be the first new vaccine to prevent TB in over a century.
The Gates MRI plans to recruit around 20 000 study participants, aged 15 to 44, across 60 trial sites in seven countries, including South Africa, Kenya, Zambia, Malawi, Mozambique, Vietnam, and Indonesia.
“If shown to be well-tolerated and effective, this TB vaccine candidate could become the first vaccine to help prevent pulmonary TB in adolescents and adults,” said Dr Alemnew Dagnew, clinical lead of the M72 programme, highlighting the importance of the trial.
“TB remains the number one killer disease in South Africa, and the Eastern Cape bears the highest TB incidence. South Africa will play its part in supporting this important trial. Our health facilities will be involved in participant recruitment,” said Miyakazi Nokwe, Acting Head of Department, on the Eastern Cape Department of Health’s enthusiasm about the project’s potential.
The Isango Lethemba TB Research Unit plays a central role in the study, supporting participant recruitment, while strengthening research capacity in the Eastern Cape.
“We need a TB vaccine to protect adolescents and adults.
“This trial will support our goal to reduce the TB burden in the region,” said Acting Deputy Director General for HIV, AIDS and STIs in the Department of Health, Ramphelane Morewane.
“TB is a complex disease which can lie dormant in the body. If the infection progresses to active TB, a person becomes ill with TB and can transmit it to others,” said Isango Lethemba TB Research Unit’s Principal Investigator, Dr Asanda Poswa. “This candidate TB vaccine aims to prevent that progression, helping to stop the spread of TB.”
The newly-refurbished Isango Lethemba TB Research Unit, a Wits Health Consortium site, has served Nelson Mandela Bay and the Eastern Cape since 2018, in collaboration with the Eastern Cape Department of Health.
Dr Thandi Dlamini Miti, Site Leader at Isango Lethemba, noted that the site has contributed to innovations in the treatment of drug-resistant TB, and is now expanding its research portfolio to include this new vaccine candidate.
The trial is funded by the Bill and Melinda Gates Foundation and Wellcome, with technical assistance and vaccine adjuvants provided by GSK.
The clinical trial welcomes participants aged 15 to 44, in good health.
Those interested in participating can call 069 990 1886 for more information.
