A first in human clinical trials to test live biotherapeutic interventions
In early March, CAPRISA hosted officials from the Gates Foundation and the Vaginal Microbiome Research Consortium. In collaboration with the Bill and Melinda Gates Foundation, the CAPRISA Vulindlela Research site will be one of two global research sites – the other is Massachusetts General Hospital in the US conducting a first in human clinical trial assessing the safety, tolerability and colonisation kinetics of a vaginally administered, live biotherapeutic intervention containing multiple strains of Lactobacillus crispatus. Preparations for the clinical trial, titled: “Vaginally Inserted Live Biotherapeutic Randomized Trial – VIBRANT”, are underway and is expected to commence in September 2023, led by Country PI and Vulindlela Research site Director, Dr Disebo Potloane.
The officials also visited the CAPRISA headquarters and met with Senior Scientist Dr Sinaye Ngcapu, and post docs Drs Andile Mtshali, and Gugulethu Mzobe. The delegation had an opportunity to visit the main laboratory where the first in human vaginal microbiome live biotherapeutic product will be tested. “The visit to the CAPRISA clinic and laboratories provided a unique opportunity to learn more about the research being conducted in South Africa, which is critical to advancing our understanding of the vaginal microbiome and developing new therapies that can benefit women worldwide, “explained Dr Ngcapu.