Kenya’s Pharmacy and Poisons Board has approved clinical trials for a Chinese Covid 19 vaccine developed from the fall armyworms.
On Friday the board posted the approval indicating 400 volunteers will be recruited for the trials at KAVI Institute of Clinical Research of the University of Nairobi. “We hope to start the trials sometime next month,” said Prof Walter Jaoko, the Principal Investigator.
Prof Jaoko is the director at KAVI Institute of Clinical Research of the University of Nairobi and has a long history in the search for an HIV vaccine globally.
He said they are in the process of preparing the testing sites at Kenyatta National Hospital, Nairobi, Kemri Welcome Trust in Kilifi and Moi Teaching and Referral Hospital in Eldoret.
The trial No: PACTR202103845381761, has already been listed with a World Health Orgsanisation recognized registry, initially expected to start this month and end in 2022.
This brings to three the number of Covid 19 vaccine candidates seeking tests in Kenya.
Others are the University of Oxford/Astra Zeneca trials going on in Kilifi and a Sanofi/GlaxoSmithKline candidate which might start later this year.
The Phase III clinical trials, of the Chinese vaccine, Prof Jaoko said will be carried out among 40, 000 participants globally aged over 18 years with Kenya the only participating country in Africa. Other countries include China, Indonesia, and Kazakhstan.
Technically known as recombinant COVID-19 vaccine (Sf9 cells), the trials are being sponsored by its developer, West China Hospital of Sichuan University, China.
Human clinical trials for the vaccine have been approved in China with phase I and II involving volunteers aged over 18 years initiated last year.
The human trials were approved after the vaccine was found efficacious, and safe in mice, rabbits, and non-human primates.
A study published in the journal Nature in July showed the vaccine to induce protection against Covid 19 without any obvious side effects.
The vaccine is developed using cells from the insect Spodoptera frugiperda, also called fall armyworm. Locally, in Kenya the fall armyworm which has caused huge crop losses since 2016 is also known as ‘viwavi jeshi’.
The technology of using insects as factories for human vaccine development started way back in the 1980s. It has been used successfully in making key cervical cancer and influenza vaccines already in use globally.
Trial participants will receive three doses of the vaccine three weeks apart within 42 days. Volunteers should not have been infected by Covid 19 though living in conditions where there is a risk of infection.
Persons who have received any Covid 19 experimental or licensed vaccine will not be eligible. Both participating males and females are expected to shelve plans to make babies during the study period and commit to using effective contraceptives.
Females of childbearing potential however must be willing to use effective contraception for 90 days after completion of the three vaccine doses.
“Males participating in this study must agree to practice adequate contraception and refrain from donating sperm for 90 days after receiving the study vaccination,” says the study protocol.
By Gatonye Gathura