Kenya has approved what may be the largest Covid 19 vaccine study in Africa in terms of regional coverage and diversity.
The study split into five arms covers all but two of the former provinces bringing Covid 19 vaccine human trials to the doorstep of most Kenyans.
The presence of the Sanofi/GSK Phase III Covid 19 vaccine study will be felt in about a dozen towns from Nairobi, Central, Coast, Nyanza, the Rift Valley, and Western Kenya.
Study sites will be in Thika, Muranga, Nairobi, Mombasa, Ganjoni, Kericho, Kombewa, Kisumu, Butere, Uasin Gishu, and Kakamega with some hosting multiple centers.
The approval published on Tuesday (3rd August 2021) by the Pharmacy and Poisons Board splits the trials into five arms overseen by multiple research organizations.
Lead organizations include the United States Army Medical Research Directorate-Kenya and its related Walter Reed Project, University of Washington, US, Aga Khan University Hospital, Kenya, Kenya Medical Research Institute, Moi University, Kenya, and the University of Nairobi.
Others include the Kenya AIDS Vaccine Initiative and the NGOs Kargeno Research Policy Hub of Kisumu and Partners in Health Research and Development which runs a major HIV programme for gays and sex workers in Nairobi.
The Kenya arm is part of a global year-long study targeting about 37,500 participants and currently recruiting in the US, Japan, Colombia, and Honduras.
The Kenya studies are, however, not specific on the targeted number of volunteers but they will be assessing the efficacy, safety, and immunogenicity of two SARS-CoV-2 vaccines in adults aged 18 years and older.
Known as VAT00008 or CoVPN 3005 the vaccines are developed by the pharmaceutical giants Sanofi Pasteur and GlaxoSmithKline. The vaccines go into Phase III trials following what Sanofi says were positive Phase II studies.
“The study will target recruitment of racial and ethnic diversity that will be representative of the countries in which the study will be conducted,” said Sanofi in a statement.
The study will allow participants with a broad range of medical conditions, including controlled HIV, Hepatitis B, and Hepatitis C, and other conditions associated with an increased risk of severe Covid19.
It will recruit both volunteers who have never been infected by Covid 19 as well as those who have recovered but in different arms of the trials.
This brings to five the number of Covid 19 vaccines being or to be tested in Kenya though this candidate has the widest geographical coverage so far.
Others include trials for the Astra Zeneca vaccine which have been completed in Kilifi County at Kenya’s Coast while Sanofi also has another paused trail registered locally.
There is also a Chinese-made candidate recently approved for local trials and the first mRna Covid 19 vaccine being coordinated by South Africans in the pipeline.
However, most of these are small single or double site studies targeting between 200 and 400 participants hence dwarfed by the Sanofi trial.
By Gatonye Gathura