Solidarity Trial Vaccine (STV) to be rolled out
Solidarity Trial Vaccines (STV) is an international Phase 3 Randomized Clinical Trial (RCT) that will test the safety and efficacy of new promising covid-19 vaccines which will soon be rolled out following approval by Kenyatta National Hospital/University of Nairobi Ethics and Review Committee, Kenya Pharmacy and Poisons Board, and the National Council for Science and Innovation.
According to the Assistant Coordinator of the STV study at Impact Research and Development Organization (IRDO), John Okanda, over 20,000 participants will be enrolled in this study. Kenya has about 10 sites, with each site targeting to enroll about 2,000 participants.
The study targets to enroll people who are 16 years and above, who have not been vaccinated against COVID-19, and who have not been infected with COVID-19. The main objective of this study is to assess the safety and efficacy of preventive candidate SARS-CoV-2 vaccines and to identify those that are likely to be appropriate for deployment to influence the course of the pandemic
During a one-on-one interview with the communication officer, the Assistant Coordinator said that currently, the vaccines that are being used on COVID-19 patients are under emergency use, pointing out that they have not gone through all the phases of a clinical trial.
He said the vaccines were rolled out through the approval of the Food Drug Administration of the United States and the World Health Organization (WHO) when the number of people who were dying from COVID 19 rose to unmanageable levels.
According to Mr. Okanda, the rise in the number of deaths is one of the reasons that prompted the need to do more research to get fully approved vaccines for preventing COVID-19. He further added that the current vaccines being used are also not enough to cater to the global demand, which leaves a gap in terms of vaccine quantities being produced and supplied.
Additionally, he added that there is a possibility the current vaccines in use only confer short-term immunity as several people have been infected or re-infected with COVID-19 after being vaccinated.
During the interview, Mr. Okanda said the study, which has been funded by WHO, will be implemented in collaboration with the ministries of health of various countries where it will be conducted. He added that in Kenya, the Ministry of Health will implement the study through Kenya AIDS Vaccine Initiative (KAVI).
Mr. Okanda revealed that in Kisumu County, the study will be conducted by IRDO at Tuungane Hospital, Nyanza Reproductive Health Society at Lumumba Hospital, Kenya Medical Research Institute’s Research Care and Treatment Program at Kar Geno Research Center, Victoria Biomedical Research Institute at Kisumu County Hospital, and Walter Reed at Kombewa. In Nairobi, the study will be conducted at KAVI and Kenyatta National Hospital, in Kericho, it will be conducted at Walter Reed, and in Kakamega County, the study will be conducted in Butere.
He said each participant will be followed for about 52 weeks after recruitment.
According to the Assistant Coordinator, IRDO is well prepared and ready to implement the trial. He said they have begun community engagement activities, for example, holding meetings with the County Health Management Teams (CHMT) of Kisumu, Siaya, Homa Bay, and Migori Counties; counties outside Kisumu will serve as satellite sites for the study, to boost enrollment. The CHMTs have approved STV to be rolled out in their respective counties.
During the interview, Mr. Okanda cited delays in the supply of pharmacy and laboratory items as some of the challenges now slowing down the rollout of the study.
In his closing remarks, Mr. Okanda said the study is timely due to the rising cases of COVID 19, and deaths that continue to occur due to the virus. “This is an indication that more vaccines are needed. Either the ones that exist already for use are not as effective or not everyone is covered, or there is a need for boosters. There is information about people being encouraged to go for boosters, meaning the current vaccines only cover individuals for a short period.”
He further said, “So we really need vaccines for COVID and we also need treatment for COVID, thus research should continue for both treatment and prevention. I think this study is timely for both those who have been affected and those who have not.”
The first Coronavirus disease (COVID-19) in Kenya was first confirmed on the 12th of March 2020, almost three months following the outbreak in China in December 2019.