Participants in South Africa’s first clinical trial for a vaccine against COVID-19 are to be vaccinated this week.
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The first clinical trial in South Africa and on the continent for a COVID-19 vaccine was announced today, 23 June, at a virtual press conference hosted by the University of the Witwatersrand, Johannesburg (Wits).
Wits University is collaborating with the University of Oxford and the Oxford Vaccine Group on the South African trial. The South African Ox1Cov-19 Vaccine VIDA-Trial aims to find a vaccine that will prevent infection by SARS-CoV-2, the virus that causes COVID-19. The technical name of the vaccine is ChAdOx1 nCoV-19, as it is made from a virus called ChAdOx1, which is a weakened and non-replicating version of a common cold virus (adenovirus). The vaccine has been engineered to express the SARS-CoV-2 spike protein.
The vaccine was developed at the University of Oxford’s Oxford Jenner Institute and is currently on trial in the UK, where over 4,000 participants are already enrolled into the clinical trial and enrolment of an additional 10, 000 participants is planned.
In South Africa, at least 80,000 people have already been diagnosed with COVID-19 and more than 1,674 have died from COVID-19 since March, when the President declared a state of disaster and national lock-down.
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.
Shabir Madhi, Professor of Vaccinology at Wits University and Director of the South Africa Medical Research Council (SAMRC) Vaccines and Infectious Diseases Analytics Research Unit (VIDA), leads the South African Ox1Cov-19 Vaccine VIDA-Trial.
“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 Madhi at the launch of the South African Ox1Cov-19 Vaccine VIDA-Trial, which is being run at multiple sites in South Africa.
“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,” says Madhi, who is also the National Research Foundation/Department of Science and Innovation SARChI (South African Research Chairs Initiative) Chair in Vaccine Preventable Diseases, based at the University of the Witwatersrand.
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University said: “We are delighted to be working with the talented team of investigators at Wits University on the first COVID-19 vaccine trial on the African continent, as researchers and scientists around the world collaborate on clinical development work with unprecedented urgency to combat the global threat to human health that is coronavirus.”
Dr Sandile Buthelezi, the Director General of Health in South Africa’s National Department of Health, said: “The National Department of Health is excited at the launch of this vaccine trial, which will go a long way to cement South Africa's leadership in the scientific space. With COVID-19 infections increasing every day, the development of the vaccine will be the last solution in the long term, and we are fully behind the team leading this trial.”
Prior to launch, the South African study was subject to rigorous review and has been approved by the South African Health Products Regulatory Authority (SAHPRA) and the Human Research Ethics Committee of the University of the Witwatersrand.
Furthermore, after eliciting and considering public comment, the Department of Agriculture, Forestry and Fisheries (DAFF) approved import of the investigational vaccine for use in the trial.
About the South African vaccine trial
The technical name of the vaccine is ChAdOx1 nCoV-19, as it is made from a virus called ChAdOx1, which is a weakened and non-replicating version of a common cold virus (adenovirus). The vaccine has been engineered to express the SARS-CoV-2 spike protein.
The vaccine was developed at the Oxford Jenner Institute and is currently on trial in the UK, where over 4,000 participants are already enrolled into the clinical trial and enrolment of an additional 10, 000 participants is planned.
The vaccine being used in the South African trial is the same as that being used in the UK and Brazil.
The vaccine was made by adding genetic material – called spike glycoprotein – that is expressed on the surface of SARS-CoV-2 to the ChAdOx1 virus.
This spike glycoprotein is usually found on the surface of the novel coronavirus and is what gives the coronavirus its distinct spiky appearance.
These spikes play an essential role in laying a path for infection by the coronavirus. The virus that causes Covid-19 uses this spike protein to bind to ACE2 receptors on human cells.
ACE2 is a protein on the surface of many cell types. It is an enzyme that generates small proteins that then go on to regulate functions in the cell. In this way, the virus gains entry to the cells in the human body and causes Covid-19 infection.
Researchers have shown that antibodies produced against sections of the spike protein after natural infection are able to neutralize (kill) the virus when tested in the laboratory.
By vaccinating volunteers with ChAdOx1 nCoV-19, scientists hope to make the human body recognise and develop an immune response (i.e., develop antibodies) to the spike glycoprotein that will help stop the SARS-CoV-2 virus from entering human cells and causing Covid-19.