Porriño, 23rd March 2021.- Two years after the first new-born baby for the MTBVAC Phase 2a trial was enrolled, the enrolment of the study has completed. Early March the last baby in the trial received a vaccination.
The South African Tuberculosis Vaccine Initiative (SATVI) conducted the study in the Western Cape of South Africa, recruiting women in the third trimester of pregnancy, following them through delivery before enrolling their newborns. Babies are followed up over a period of 12 months. In total 99 healthy, BCG naïve, HIV unexposed newborns are enrolled into this study.
The completing of the enrolment is specially celebrated due to a challenging 2020 with unexpected and unavoidable major issues, namely the COVID-19 pandemic and lockdown in South Africa.
The restrictions imposed by the COVID-19 lockdown in South Africa impacted the duration of the study. These lockdown measures were implemented, firstly, to prevent rapid spread of infection and, secondly, to assist government in preparing for a potential increase in COVID-19 admissions to hospitals causing strain on the South African health care system. Therefore, measures resulted in closure of all sectors whilst only allowing essential services to proceed until beginning October 2020.
Fortunately, the study activities resumed from October 2020, which resulted in the completion of the enrollment early March.
This trial is funded and supported by the European and Developing Countries Clinical Trials Partnership (EDCTP).

[Picture: the first new-born baby that was enrolled for the Phase 2a study in 2019 and the last baby that was enrolled for this study in 2021 with their mothers and the Satvi-team]

A Phase 3 efficacy study is planned to start for early 2022. This will be an important step with the planned MTBVAC vaccination of nearly 7 000 infants.
This large, phase 3 clinical trial is partially funded and supported by EDCTP.