SAMRC and DSI invest R10 million into the first Covid-19 vaccine trial in South Africa
Cape Town | The South African Medical Research Council (SAMRC) and Department of Science and Innovation (DSI) have provided R10 million funding into the first Covid-19 South African vaccine trial. The South African Ox1Cov-19 Vaccine VIDA-Trial was announced on 23 June 2020 at a virtual press conference hosted by the University of the Witwatersrand (Wits).
The clinical trial, which aims to find a vaccine that will prevent infection by SARS-CoV-2, the virus that causes Covid-19, will be conducted by Wits in collaboration with Oxford University and the Oxford Jenner Institute – with the first participants being vaccinated this week.
The country has at least 100,000 people who have already been diagnosed with and more than 2,000 have died from Covid-19 since the first reported positive case in March. By 17 June 2020, South Africa had contributed to 30% of all diagnosed Covid-19 cases and 23% of all deaths related to it on the continent – calling for an urgent need for prevention interventions in Africa.
According to SAMRC President and CEO, Prof Glenda Gray, there are currently over 100 candidate Covid-19 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-19 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,” Gray said.
She added that the SAMRC is looking at two more vaccine trials for Covid-19 later this year as part of developing local vaccine solutions and innovations. “Multiple successful vaccines will help in making wide-scale and rapid immunisation a reality.”
SAMRC continues to champion health research amidst Covid-19
Since the advent of Covid-19, the SAMRC has been instrumental in the country’s response not only by actively participating in monitoring the outbreak – the organisation has heeded the call from the beginning through laboratory investigations, clinical research and public health studies on this pandemic.
To support health care innovation across these research streams, approximately R95 million has been ringfenced by the SAMRC and the Department of Science and Innovation (DSI) to catapult research and innovation on Covid-19. R56 million of this already committed to projects covering epidemiology, disease surveillance, treatment and diagnostics. The funds include a contribution of R5 million from the Technology Innovation Agency (TIA), specifically for diagnostics and medical devices to be funded through the SAMRC.
As the fight against Covid-19 intensifies, the SAMRC has been at the forefront when it comes to public health research. Through our intramural research units we are engaged in a broad spectrum of studies looking into health impacts of Covid-19 and the lockdown across research streams, from Gender Based Violence (GBV), Covid-19 and the Impact on Substance Use, among other public health studies.
Through our extramural research units, we are contributing to knowledge on Covid-19 with experts based at universities and collaborating centres of excellence. The SAMRC’s investments and research and development coordination activities are designed to directly support national efforts to curtail and respond to the pandemic.
More about the trial
Shabir Madhi, Director of the SAMRC/WITS Vaccines and Infectious Diseases Analytics Research Unit (VIDA) and Professor of Vaccinology at Wits, who leads the Trial said: “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.”
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. 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 USA.
According to Prof Helen Rees, Chair of SAHPRA and Executive Director of the Wits Reproductive Health and HIV Institute (Wits RHI), it is essential that vaccine studies are performed in southern hemisphere countries, including in the African region, concurrently with studies in the northern hemisphere countries. “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 immunization programmes for low-middle income countries frequently lags behind those in high-income countries.” Rees said.
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 Organization to ensure equitable access for all countries, including those in Africa, should a successful vaccine be developed.
NOTE TO THE EDITOR:
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.
Research sites
Researchers at sites in Gauteng will begin testing the Covid-19 vaccine in human volunteers on Wednesday, 24 June 2020. The study is being undertaken in urban metropoles where the risk of SARS-CoV2 infection is high, and which are likely to be Covid-19 hotspots. The study may be extended to sites in Cape Town over the next few weeks.
Participants
The study aims to enrol 1,950 adult volunteers aged 18-65 years and who are HIV negative. They should not have tested positive for Covid-19 and should not be pregnant or breast-feeding, nor have previously participated in a trial with an adenoviral vaccine or received any other coronavirus vaccine.
The trial will also enrol a smaller number (50) of people living with HIV to examine the safety and how well they respond to the vaccine.
Participants will need to provide written informed consent to participate in the trial and they will remain on the trial for approximately one year.
Trial implementation
Half of the participants will receive the ChAdOx1 COVID-19 (ChAdOx1-Cov19) vaccine and the other half (the control group) will receive a placebo (normal saline).
The random grouping of participants to receive either the vaccine or the placebo helps researchers understand participants’ response to ChAdOx1-Cov19, its safety, and whether the vaccine protects against Covid-19.
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 dose used in this trial was chosen based on previous experiences with other ChAdOx1-based vaccines and the study currently underway in the UK.
Niether participants or investigators will not know until the end of the trial whether the participants received the CHADOX1-Cov19 vaccine or the control.
Participants will be given an E-diary to record any symptoms experienced for seven days after receiving the vaccine. They will also record if they feel unwell for the following three weeks.
Following vaccination, participants will attend a series of follow-up visits. During these visits, 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.
If participants develop Covid-19 symptoms during the study, they can contact a member of the clinical team who will assess them for infection. Should a participant become particularly unwell, they will be assisted to seek hospital care.
Results
To assess whether the vaccine works to protect from Covid-19, statisticians in the research team will compare the number of infections in the placebo group with the number of infections in the vaccinated group. For this purpose, it is necessary for a small number of participants to contract Covid-19.
How quickly researchers reach the numbers required will depend on the levels of virus transmission in the community. If transmission remains high, enough data may become available in a couple of months to see if the vaccine works. If transmission levels drop, however, this could take up to six months or longer.
Outcome
Although there are more than 100 COVID-19 vaccines currently in development, a significant proportion of vaccines that are tested in clinical trial are found not to be suitable for further development. The ChAdOx1-Cov19 vaccine is one of only five vaccines that are currently in the clinical development phase in humans, with the studies mainly being done in China, USA, UK, Australia and Europe.
If this trial in South Africa is unable to show that the vaccine protects against COVID-19, or that it is not safe, progress will be reviewed and alternative approaches explored. The study is monitored intensely by an independent Data, Safety and Management Committee, which includes a leading South African scientist.