The first participants in South Africa’s first clinical trial that seeks to develop a vaccine against COVID-19 are being vaccinated this week.
The first clinical trial in South Africa and on the continent for a COVID-19 vaccine was announced today, 23 June 2020, at a virtual press conference hosted by the University of the Witwatersrand, Johannesburg (Wits).
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.
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 lockdown.
By 17 June 2020, South Africa (population: 59m) contributed to 30% of all diagnosed COVID-19 cases and 23% of all COVID-19 deaths on the African continent (population: 1.34bn). 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.
Wits University is collaborating with the University of Oxford and the Oxford Jenner Institute on the South African 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 Zeblon Vilakazi, vice principal and deputy vice-chancellor: research and post-graduate affairs at the Wits University, who facilitated the virtual press conference, said: “Wits University identified vaccinology as a key institutional flagship project in 2016. Vaccines are amongst the most powerful tools to mitigate life-threatening diseases. Without a vaccine against Covid-19, there will likely be ongoing contagion, causing severe illness and death. Wits is committed to developing a vaccine to save lives in collaboration with the University of Oxford.”
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.
South African participation in international trials
The vaccine is already being evaluated in a large clinical trial in the UK where more than 4,000 participants have already been enrolled. In addition to the South African study, similar and related studies are about to start in Brazil. An even larger study of the same vaccine of up to 30,000 participants is planned in the US.
“It is essential that vaccine studies are performed in southern hemisphere countries, including in the African region, concurrently with studies in northern hemisphere countries,” says Professor Helen Rees, chair of SAHPRA and executive director of the Wits Reproductive Health and HIV Institute (Wits RHI).
“This allows evaluation of the efficacy and safety of candidate vaccines to be assessed in a global context, failing which the introduction of many life-saving vaccines into public immunisation programmes for low-middle income countries frequently lags behind those in high-income countries.”
Rees also co-directs the Wits African Leadership in Vaccinology Excellence (ALIVE) flagship programme and is engaged in global discussions with Gavi, the Vaccine Alliance and the World Health Organisation to ensure equitable access for all countries, including those in Africa, should a successful vaccine be developed.
About the South African vaccine on 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 (develop antibodies) to the spike glycoprotein that will help stop the SARS-CoV-2 virus from entering human cells and causing COVID-19.
Local application of a global response
In addition to the more than 4,000 people already vaccinated in the UK with the ChAdOx1 nCoV-19 vaccine, other vaccines made from the ChAdOx1 virus have also been given to more than 320 people to date. These vaccines have been shown to be safe and well-tolerated, although they can cause temporary side effects, such as a temperature, headache or a sore arm.
There are currently over 100 candidate COVID vaccines in development around the world and many of South Africa’s best vaccine research institutions will soon be involved in a range of vaccine studies evaluating other types of potential COVID vaccines.
“As the world rallies to find health solutions, a South African endeavour for the development of an effective COVID-19 vaccine is testament to our commitment of supporting healthcare innovation to save lives,” says Professor Glenda Gray, president and CEO of the South African Medical Research Council.
Dr Sandile Buthelezi, the director general of health in the 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.”
The trial is one of three currently being run
South Africa, the UK and Brazil are part of the three studies related to this vaccine that are currently underway. The study in the UK is ongoing and has already enrolled more than 4 000 participants, and an even larger study of 10 000 is due to start soon. Brazil’s study is underway and has enrolled approximately 5 000 participants.
Inclusion criteria for study volunteers involved a number of factors, said Madhi, including: healthy adults aged 18–65 years; provision of written informed consent (includes an assessment of understanding of the study); documented result of not being infected with HIV. Able and willing to comply with all study requirements; for females only: a willingness to practise continuous effective contraception and a negative pregnancy test; for Groups-3 only (HIV-infected): need to have been on antiretroviral treatment for at least three months with HIV-1 viral load being <1 000 copies/ml within two weeks of randomisation.
Health24 reports that people who were excluded from participating in the study include pregnant and breastfeeding women, as well as those who expressed a willingness to become pregnant during the course of the study.
Those with a history of severe disease, substance abuse, chronic respiratory (including asthma) or cardiovascular illness, were also excluded, as well as people who presented with an onset of cough or shortness of breath within the past 30 days. Madhi further expressed that a key goal of the study is to evaluate the safety of the vaccine in people with and without HIV.
The anticipated study timeline will include the first participant being enrolled this week, with a complete enrolment taking place across multiple sites by mid-August of this year, said Madhi.
There will be planned follow-ups, up to 12 months after vaccination and participants will have fortnightly appointments to assess for any respiratory illness. They will also be investigated for COVID-19 in the event that they fulfil criteria that indicate illness.
An ongoing evaluation of safety by the Independent Data and Safety Management Committee (for UK, Brazil and South African studies) will also be part of the study, Madhi added.
[link url="http://www.wits.ac.za/covid19vaccine/"]Issued by: University of the Witwatersrand[/link]
[link url="https://www.health24.com/medical/infectious-diseases/coronavirus/6-things-you-need-to-know-about-the-first-sa-covid-19-vaccine-trial-20200623?_sp=9566b7a4-acdc-4d60-8162-a289492a1291.1592918981346"]Full Health24 report[/link]