The Navrongo Health Research Centre has commenced the first trial of a covid-19 vaccine called the Sputnik-Light Vector Vaccine in Ghana. The vaccine was designed by the Gamaleya Scientific Research Center of Epidemiology and Microbiology in Russia. The vaccine trial began on 29th June 2021 with the recruitment of participants who volunteered at their own will at the Clinical Trials Centre of the Centre.
The trial titled “A Phase III, Randomized, Double Blind, Placebo-Controlled International Multisite Clinical Trial in Parallel Assignment to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik Light Vector
Vaccine in Adults in the SARS-CoV-2 Infection Prophylactic Treatment” is expected to be carried out in healthy individuals within the Kassena-Nankana Districts of the Upper East Region.
Prior to the commencement, the NHRC held a day’s engagement with the Paramount Chiefs of the Kassena-Nankana traditional area to solicit their views and seek their blessings to begin the education process on its intention to carry out the Covid-19 Vaccine Trial.
A welcome address during the engagement by the Acting Director of the NHRC, Dr. Patrick Ansah acknowledged the continuous and immense support of the traditional chiefs in the work of the Centre for the past decades. He informed them that, the new Covid-19 disease that has led to the loss of life of about three million people worldwide has been a source of worry for many scientists and in a search for a solution, many vaccines have been developed. He made mention that, the vaccine originating from Russia called the Sputnik Light Vector Vaccine is one of the many vaccines being tried out in order to control the deadly corona virus. The Sputnik Light Vector Vaccine is in its third phase of trial and it is expected to be carried out in some African countries to assess its safety and efficacy in adults, of which the Navrongo and Dodowa health research centres are partaking in Ghana.
In a presentation by the institution’s PI, Dr. Nana Akosua Ansah, she mentioned that the study’s Global Sponsor is planning several parallel studies of the Sputnik-Light vector vaccine across the globe including a study in Russia and possibly in other countries yet to be confirmed with the same investigational product and under similar protocols. The protocol designs would enable the participating countries in the compilation of data to confirm efficacy, immunogenicity, safety and tolerability of Sputnik-Light vector vaccine and the data from this study would be submitted to the regulatory agencies in Russia, Ghana, the UAE and possibly other jurisdictions as part of the Sponsor application to obtain Emergency Use Authorization to market the study vaccine in these countries, and subsequently Marketing Authorizations in Russia, UAE, Ghana and other jurisdictions.
She added that about 7000 healthy subjects aged between 18 and 60 years old would be recruited into the study for a period of one year on voluntary basis. These volunteers would be required to take a solution of 0.5 ml per dose of the Sputnik-Light vector vaccine for intramuscular injection at day 1. After the vaccine injection, participants would visit the clinical trial centre on prescribed dates and time for tests to be done in order for a study physician to assess their state of health and any change in personal condition. During the study period also, any study subject who experiences untoward event including but not limited to abnormal laboratory results of medical significance, the Centre would be required to report as adverse events and all serious AEs/ADRs (Related and Unrelated) would be communicated to the Sponsor or its designee within 24 hours of investigator awareness of the event, as well as the Food and Drugs Authority of Ghana.
In an interactive session, the chiefs applauded the Centre for its good works since its inception and encouraged the management and staff to continue to work hard for the improvement of Navrongo and the country at large. They pledged their support to the Centre for the successful completion of the study which would go a long way to improve the covid-19 situation in the country.
The engagement with the traditional chiefs took place at the Pe. Dr. A. B. Adda Conference Hall of the Centre on 1st June, 2021.
The trial has since commenced and the recruitment and training of qualified doctors, nurses and laboratory scientists has been done. These staff were trained from 17th-18th and 21st of June, 2021 at the Centre’s Pe. Dr. A. B. Adda Conference Hall to enable them carry out their various roles for the success of the trial. The areas of training included study protocol, identification and registration of participants, consenting process, sample taking, and testing and collation of sampled results.
The vaccine trial commenced after the Food and Drugs Authority (FDA), the Ghana Health Service (GHS) and the NHRC Institutional Review Board had given their approvals. Participation in the trial has been impressive so far and recruitment targets are on course.
