- South Africa will be testing a new experimental Covid-19 vaccine
- This trial will form part of a larger study taking place in nine countries overall
- The trial will initially focus on people between the ages of 18 and 60 and will include people living with HIV
The Desmond Tutu Health Foundation, the South African Medical Research Council and pharmaceutical company Johnson & Johnson recently launched the Ensemble study.
This clinical trial will research an experimental Covid-19 vaccine that scientists hope will protect people from becoming infected with the new coronavirus or developing serious Covid-19.
The experimental vaccine has already been given to more than 800 participants in a smaller study in Belgium and the United States, which showed it was safe to use.
The vaccine will now be part of a much larger study in nine countries, including the United States, Argentina and South Africa.
As part of the research, people over the age of 18 will be randomly assigned to either get the experimental vaccine or a placebo, in this case, a simple saltwater solution.
Neither patients nor doctors will know if they have been given the real vaccine or not.
Because patients in the trial are randomised to receive either the vaccine or the placebo, any factors such as age or clinical history should be equally divided between both groups, which means that the study will be better able to show cause and effect than non-randomised studies.
The new experimental coronavirus vaccine will – like many others – use a common virus called adenovirus to help deliver proteins into the body and hopefully trigger an immune system response. Adenoviruses occur naturally and have been used safely for decades in vaccine research for illnesses such as malaria, Ebola and HIV.
To date, over 90 000 subjects have received Adenovirus-based vaccines, including more than 76 000 participants in an ongoing Ebola vaccine study in the Democratic Republic of the Congo
A research review undertaken by Johnson & Johnson of almost 5 000 adults and children found the most common temporary side effects of receiving an adenovirus-based vaccine were feeling generally unwell or tired, experiencing headaches, and some muscle pain.
People living with HIV included
South Africa’s latest Covid-19 vaccine trial is expected to take three years and joins two other trials already in progress.
Initially, the latest trial will focus on people between the ages of 18 and 60 and will include people living with HIV. As researchers and independent monitors of the study learn more about how the vaccine works, the Ensemble trial will expand to include people over the age of 60 and those with underlying health conditions such as hypertension, obesity and diabetes.
Clinical research conducted in South Africa must include people living with HIV – more than one in 10 South Africans according to the country’s latest HIV household survey.
Studies conducted in South Africa have to produce medical solutions that work for South Africans and the continent, including people living with HIV.
Today, we know that people who are older and who have underlying health conditions such as diabetes and hypertension are most at risk of dying from Covid-19.
A recent study published in the South African Medical Journal found that people with HIV and tuberculosis may also face a heightened risk of death from Covid-19.
Meaningful community engagement
The Ensemble study’s decision to include those in our society most vulnerable to Covid-19 is a brave but necessary move.
Should the Ensemble trial work, Johnson & Johnson has committed to providing an affordable Covid-19 vaccine to the public on a not-for-profit basis, according to a September statement.
The first batches could be available in early 2021 if the vaccine works. The company has also committed to transparency, releasing the Ensemble study’s full protocol, which outlines in detail how the trial will be carried out.
However, reading through the Ensemble study protocol, it is concerning that the phrase “community engagement” does not appear in the document.
Whether it is within the context of new diseases such as Covid-19 or more familiar epidemics such as HIV, the World Health Organization (WHO) and bodies such as UNAIDS have repeatedly called on clinical trials to include meaningful community engagement. This not only to ensure the ethical and scientific quality of studies but also their relevance to, and acceptance by, communities that stand to benefit from interventions.
Community representatives must have a voice
Each clinical trial site for the Ensemble study in South Africa has an existing community advisory board. Community advisory boards are comprised of community members, local leaders and civil society organisations meant to ensure that communities’ interests are protected during clinical trials.
Still, it is unclear how communities will be meaningfully engaged, given the glaring absence of the phrase “community engagement" in the protocol.
The world desperately needs effective vaccines and medicines to treat Covid-19, and the quest to develop these has pushed science to find new and expedited ways of developing them.
Phases of clinical research that once might have run one after the other are now being combined or run in parallel under the watchful eyes of independent reviewers, ethics bodies and national regulators.
But in the rush to find effective solutions to Covid-19, we cannot afford to leave communities behind.
Community engagement cannot only be an afterthought once ethics review committees and regulatory bodies have approved trials. Community representatives should have a voice right from the start including in the design of trials.
Power of civil society
Ensuring that communities are not left behind or ignored is crucial to maintaining trust in the research that will one day produce new immunisations and treatments.
South African activists have decades of experience in advocating for meaningful community engagement in clinical research. Professor Linda-Gail Bekker, the Ensemble Co-Chair, echoed this in a recent podcast conducted with activists on the launch of the trial.
“We have seen the power of civil society and advocacy groups saying that these minimum standards [for community engagement] cannot be transgressed,” she said. “It does not matter how strong the political pressure… [or the] power struggles that come in; we have to maintain them.
"[Scientists and civil society] can watch each other in that regard.”
As this landmark Covid-19 trial is launched, civil society, now more than ever, needs to be aware, strategic and unrelenting in how we hold our governments, researchers, regulators and funders to account.
Tian Johnson is founder and lead strategist of the African Alliance, member and convener of the Vaccine Advocacy Resource Group and founder of the Global Covid-19 Civil Society Platform for Research & Advocacy. They are also the International Civil Society Observer of the Robert Carr Fund – the world's leading international fund focused on funding regional and global networks led by and involving and serving inadequately served populations (ISPs).