Dr. Nana Akosua Ansah taking the AMMREN team through the Sputnik Light vaccine trial
The Navrongo Health Research Centre (NHRC) of the Research and Development Division (RDD) under the Ghana Health Service (GHS) has begun the phase III clinical trials for the Sputnik Light Vaccine in the Kassena-Nankana Municipality of the Upper East Region.
The testing of the single-dose vaccine produced by the Gamaleya Institute of Epidemiology and Microbiology in Russia puts Ghana on the global map for the development of Covid-19 vaccines.
The trials which begun in June, 2021 has so far seen 495 residents of the Municipality partaking in the clinical exercise.
Dr. Nana Akosua Ansah
Head of Clinical Science Department of NHRC, Dr. Nana Akosua Ansah, speaking with journalists from the African Media and Malaria Research Network (AMMREN) during a field visit said already, Sputnik Light Vaccine has been tested in smaller-scale, Phase I/II clinical trials adding that the phase three trial is to demonstrate the safety and effectiveness of the new vaccine in the typical patient who is likely to use it.
Dr. Ansah explained that for this trial, participants received either the vaccine or a placebo after going through the stages of registration, consent and counseling, and medical examination.
“The recruitment started in June 2021, and currently, there are three visits. The first visit is the enrollment visit, the second visit is just a follow up, and the third visit is the final visit which would be conducted from December, 2021,” she said.
She said the study for the Sputnik Light Vaccine is expected to last for six months, explaining that after the vaccine or the placebo is administered, health officers follow up on participants on a weekly basis by phone calls for any adverse effects to be forwarded to the Food and Drugs Authority (FDA).
According to her, the NHRC had received a favourable response from the Municipality because of its long standing research credibility.
“There is a culture of research here, so we have overwhelming response with people prepared to stay the whole day just take part in the trials,” she said.
Sanofi Vaccine Trial
Dr. Ansah further noted that the centre is set to start the trial for another vaccine, Sanofi, produced by the Sanofi Pasteur S.A.
She said about 1,800 trial participants would be recruited in stage one and given the monovalent vaccine or placebo while the second stage trial would involve the use of a bivalent vaccine in addition.
She said the NHRC had so far recruited close to 500 trial participants for the stage one and explained that “For the stage one, we are looking at comparing a monovalent vaccine against placebo, and the stage two is a bivalent strain to also cater for the additional strains of Covid-19.”
“There are two doses and subsequently all the visits are to follow up and pick adverse effects just to see how safe and efficacious the vaccine is, and stage two will also follow with the same schedule.”
NHRC is part of three research centers conducting the Covid-19 vaccine trials. The other two are the Kintampo Health Research Centre (KHRC) and the Kumasi Centre for Collaborative Research (KCCR).
By Jamila Akweley Okertchiri, Navorongo