The University of the Witwatersrand has announced South Africa’s first Covid-19 vaccine trial and its first participants will be enrolled this week.
This comes as the country breaches 100 000 cases of Covid-19. Participants are to be divided in three groups – two groups include HIV-negative participants and one group includes people living with HIV.
The trial aims to find a vaccine that will prevent SARS-CoV-2 infection, which is the virus that causes Covid-19.
“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, said in a virtual briefing on Tuesday.
“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 added.
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.
According to Madhi, participants will form part of three groups: Group One, which will comprise 50 people who are HIV negative;Group Two, comprising 1 900 participants who are HIV negative; andGroup 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.
The trial will also enrol 50 persons living with HIV to examine the safety and see 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 trial for about one year.
The study, which will come at a cost of R150m, will take place in “urban metropoles where the risk of SARS-CoV2 infection is high, and which are likely to be Covid-19 hotspots”.
“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 will be implemented through half of the participants who will receive the ChAdOx1 COVID-19 (ChAdOx1-Cov19) vaccine and the other half (the control group) will receive a placebo (normal saline).
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.
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.
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 seeking hospital care.
According to the institution, the objective of the trial is to investigate if the ChAdOx1-Cov19 vaccine will protect against Covid-19, doesn’t cause unacceptable side effects, and if it induces satisfactory immune responses.
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 said.
“We have also breached a high level of deaths in the country . We currently mainly depending on no -pharmaceutical interventions so if there is any way we can fast track out road to getting the vaccine, that will be the long-lasting solution that we have as a country,” he concluded.(allafrica.com)