Several COVID-19 vaccine trials are taking place across the world, and the University of the Witwatersrand has announced that South Africa’s first COVID-19 vaccine trial will begin this week. The announcement was made today, June 23 during a virtual press conference hosted by the university.
The South African Ox1Cov-19 Vaccine VIDA-Trial is in collaboration with the University of Oxford and the Oxford Jenner Institute. It aims to find a vaccine that will prevent SARS-CoV-2, the virus that causes COVID-19. The study will cost approximately R150-million to conduct.
“By 17 June 2020, South Africa (population: 59 million) contributed to 30% of all diagnosed Covid-19 cases and 23% of all Covid-19 deaths on the African continent (population: 1.34 billion). These statistics emphasise the urgent need for prevention of Covid-19 on the continent,” says the university.
“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,” said Professor of Vaccinology at Wits University and Director of the South Africa Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Shabir Madhi, who is leading the trial.
“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 said.
The participants will form three groups:
– Group One will comprise of 50 individuals who are HIV negative
– Group Two will comprise of 1 900 individuals who are HIV negative
– Group Three will comprise of 50 individuals who are HIV positive
This means that there will be a total of 1 950 individuals who are HIV negative participating in the trial, and they should not be pregnant or breastfeeding, and should also have tested negative for COVID-19. All participants will be aged between 18 and 65 years of age.
The trial will also have 50 persons living with HIV for the purposes of gauging safety, and also see how they react to the vaccine.
Those who wish to partake in the trial must provide written consent, and the trial will be ongoing for a year. The study will take place in various metropoles, particularly in 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 said.
Half of the participants will receive the vaccine, called ChAdOx1 COVID-19 vaccine, while the other half will receive a placebo of saline solution. Participants will be required to use an e-diary to record if they feel unwell in the three weeks following the administering of the vaccine (or placebo).
A series of follow-ups will take place and researchers will check the participant’s observations, and review the e-diaries. Blood samples will also be taken from the participants and these will be used to assess the immune response to the vaccine.
Those who develop symptoms of the virus during the study will be encouraged to contact a member of the clinical team and those who feel unwell will be assisted in finding medical care.
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