The University of Witswatersrand has announced that South Africa’s first COVID-19 vaccine trial is set to begin, with participants to be enrolled by the end of the week.
“This is a landmark moment for South Africa and Africa at this stage of the COVID-19 pandemic. As we enter winter in South Africa and pressure increases on public hospitals, now more than ever we need a vaccine to prevent infection by COVID-19,” Professor of Vaccinology at Wits University and Director of the South Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Shabir Madhi, says in a virtual briefing.
This new trial aims to find a vaccine that will prevent SARS-CoV-2 infection, which is the virus that causes COVID-19.
“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,” he adds.
The trial comes after South Africa recorded 101,590 positive cases on Monday night, and a further 61 deaths, taking the death toll to 1 991.
Implementation of the trial
According to Madhi, the participants will form 3 groups.
- Group One, which will comprise 50 people who are HIV negative;
- Group Two, comprising 1 900 participants who are HIV negative; and
- Group Three, comprising 50 people living with HIV.
The 1 950 participants, aged between 18 to 65 and who are HIV negative, should not have tested positive for COVID-19 and should not be pregnant or breastfeeding, nor have previously participated in a trial involving an adenoviral vaccine or received any other coronavirus vaccine, according to News 24.
50 participants living with HIV are to be enrolled in the trial in order to examine the safety and how well they respond to the vaccine. In addition, participants will need to provide written informed consent to participate in the trial and they will remain on the trail for about one year.
“Our best-case scenario is that we would have an answer [on the outcomes] for this particular vaccine by the end of the year,” Madhi added. The trial is set to cost around R150 million ($8.7 million).
The trial itself
Half of the participants will receive the ChAdOx1 COVID-19 (ChAdOx1-Cov19) vaccine and the other half (the control group) will receive a placebo (saline solution). Participants will also receive an e-diary to record any symptoms they experience over 7 days since being given the vaccine. They will have to record any symptoms and how they feel for a further three weeks.
Following vaccination, the participants will then go through a process of follow-ups where researchers will check participants’ observations, review the completed diaries, and take blood samples, which will be used to assess the immune response to the vaccine.
Reaction by South Africa’s Department of Health
The National Department of Health has pledged its support stating that the trial could not have come at a better time.
“South Africa must always lead from the front, there would be no better time than today to actually launch this vaccine trial as the country has reached a landmark of over 100,000 infections recorded last night,” Director-General, Dr Sandile Buthelezi says.
IT News Africa