By Priscilla Oye Ofori, GNA
Accra, June 23, GNA- The Dodowa Health Research Centre on Wednesday, engaged stakeholders on the trial of the Sputnik Light Vaccine, a single dose COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia.
The meeting, held at Dodowa in the Shai Osudoku District of the Greater Accra Region, was on the theme: “A Phase III, Randomised, Double Blind, Placebo- Controlled International Multisite Clinical Trial in Parallel Assignment to Evaluate Efficacy, Immunogenecity and Safety of the Sputnik Light Vector Vaccine in Adults in the SARS- COV-2 Infection Prophylactic Treatment.”
Dr Alberta Amu, Principal Investigator for the Sputnik Light Project, said the goal of the trials was to assess the efficacy, tolerability, safety and Immunogenicity of the Sputnik-Light vector vaccine against SARS-CoV-2-induced coronavirus infection compared to placebo.
She said the data from the 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 the countries, and subsequently Marketing Authorizations in Russia, UAE, Ghana and other jurisdictions.
Dr Amu, also a Clinical Research Scientist at the Dodowa Research Centre, said the trial, which would begin on June 28, 2021, and end in January next year, would be conducted on 500 community members in the Shai Osudoku and the Ningo Prampram Districts.
She said the exercise would allow the country to get the vaccines easier.
“The risk of variants means vaccinations against COVID-19 should be expedited. Only one shot assures compliance and it is cost-effective,” she said.
The participants in the trials would be screened, vaccinated and observed for about 42 days with daily phone call follow-ups post-vaccination for 21 days.
The follow-ups would then be reduced to weekly phone calls to ensure there were no complications.
Dr Amu said the criteria for participation in the trials included, adults who were 18 years and above, willing to sign the study informed consent form (1CF) before performing any study-specific procedure.
Participants must also not have COVID-19, which would be confirmed with negative test result and had no acute infectious and or respiratory diseases within at least 14 days before the enrolment.
She said people, including those who had been vaccinated or immunised within 30 days before the enrolment and any planned vaccination within 30 days after enrolment were not qualified to undertake the trial, as well as people who had COVID-9 vaccination or planned vaccination against COVID-19 with another vaccine.
Dr Amu said participants would have insurance cover- health and life for the period of the study, reimbursement for transport and time used in attending the clinic.
The Principal Investigator said they would sensitise community members by visiting places of worship, markets, community groups and other stakeholders before the trials commenced.
Dr John Williams, Director of the Dodowa Health Center, said vaccines played important role in the protection of humans from infectious diseases but unfortunately Africa stayed out of the trials for COVID-19 vaccines making it difficult for its Governments to get enough for the people.
He, therefore, encouraged the locals to participate in the trials to protect themselves and others.
Dr Williams stressed the need for all to continue to adhere to the COVID-19 safety protocols because, “The country has been caught up in a difficult situation and must not let our guards down.”
He urged stakeholders to support the trials by educating community members on its importance.