Braamfontein – Wits University has announced South Africa’s first Covid-19 vaccine trial to find medication that will prevent SARS-CoV-2 infection, the virus that causes Covid-19.
In a virtual briefing on Tuesday Wits Professor of Vaccinology and Director of the South Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Shabir Madhi, said this is a landmark moment for South Africa and Africa at this stage of Covid-19.
“As we enter winter and pressure increases on public hospitals, we need a vaccine to prevent Covid-19 infection. We began screening participants for the South African Oxford 1 Covid-19 vaccine trial last week, and the first participants will be vaccinated this week,” Madhi said.
He explained that participants will be set up in three groups.
“Group One has 50 HIV negative people; Group Two comprises 1 900 HIV negative participants; and Group Three with 50 people living with HIV. The 1 950 participants, aged between 18 to 65, and who are HIV negative, must not have tested positive for Covid-19. They also should not be pregnant or breastfeeding, or previously participated in a trial involving an adenoviral vaccine, or received any other coronavirus vaccine.”
The 50 people living with HIV are included to examine safety and see how they respond to the vaccine. Participants will need to provide written, informed consent to participate in the trial, and will remain on the trial for about a year.
Madhi added that the trial will cost R150 million, and will be carried out in metropolitan areas where the risk of SARS-CoV2 infection is high, and Covid-19 hotspots. “Our best-case scenario is that we have an answer on the outcomes for this trial vaccine by the end of the year,” he added.
Half of the participants will receive the ChAdOx1 COVID-19 (ChAdOx1-Cov19) vaccine and the other half will receive a placebo (normal saline). The participants will be given an e-diary to record any symptoms experienced for seven days after receiving the vaccine, and they will also record if they feel unwell for the following three weeks.
The participants will then go through a process of follow-ups where researchers will check participants’ observations, review the completed e-diaries, and take blood samples, to be used to assess the immune response to the vaccine. Participants who develop symptoms of the virus during the study can contact a member of the clinical team, and participants who feel unwell will be assisted in finding hospital care.
Department of Health director-general Dr Sandile Buthelezi said: “There would be no better time than today to launch this vaccine trial, as the country has reached a landmark of over 100 000 infections; and have breached a high level of deaths in the country. We are mainly depending on non-pharmaceutical interventions, if there is a way we can fast-track our road to getting the vaccine; that would be the solution.”