This video explains the collaboration between KWTRP and the University of Oxford to review the ChAdOx1 nCOV-19 vaccine and conduct phase I and II trials in Kenya.
The KEMRI Wellcome Trust Research Programme is based in Kenya under the Ministry of Health, and brings together leading scientists from Kenya, from Africa and from around the world. Our work has contributed to improved health through the development and evaluation of ways to treat and prevent diseases like malaria, yellow fever, pneumonia and Ebola.
KEMRI’s research is informed and supported by community and stakeholder engagement. This engagement, combined with meeting National and international guidelines, ensures that our work meets the highest ethical standards.
Given the current COVID-19 pandemic, it is essential that Kenyan researchers play a prominent role in addressing one of the greatest health challenges of our time. Kenyan researchers from KEMRI-Wellcome Trust Research Programme are currently collaborating with researchers from the UK to evaluate a new vaccine called ChAdOx1 nCoV-19.
So how will this vaccine work and how will researchers evaluate it to see if it gives protection?
People who have never had COVID-19 can easily become infected themselves if they come into close contact with a person who has the disease. This is because they have no natural immunity, or defence to protect them against infection. Being infected may enable the body to build natural immunity which may prevent a second infection. Vaccines mimic this. When a person is vaccinated, the vaccine stimulates the body to produce an immune response, or a defence against infection.
A tremendous amount of lab work is needed to develop a vaccine and this can take many years. From the initial lab work, trial vaccines are first tested on animals, and if safe, they proceed through different stages of clinical trials with people. Initially, trials with relatively small numbers of volunteers are done to see how the body’s defense responds to the vaccine and to confirm the vaccine’s safety. Then trials are done with larger numbers of volunteers to see whether they give protection against disease. When there is strong, carefully reviewed evidence of protection, regulatory bodies give permission for the vaccines to be rolled out to large populations, but the vaccines are still monitored. The whole process of developing and evaluating a vaccine can take many years
Before any health research can be done with people in Kenya, the research must be carefully reviewed and approved by local, national and international scientific and ethical committees. These committees check that the scientific plan is strong, that the risks to participants are minimized and that their rights are guarded.
So let’s have a closer look at how the new ChAdOx1 trial vaccine is made.
This is a picture of an Adenovirus, which causes a mild flu amongst chimpanzees. It can be used to deliver the vaccine into the human body, but first, the adenovirus is modified so that it cannot cause any disease in humans.
Then, researchers carefully extract a component of genetic material from a COVID-19 virus and insert it into the genetic material of the adenovirus. This specific component stimulates the human body’s immune response. More of this modified adenovirus is made so that a vaccine can be prepared.
A similar approach was used to make the Ebola vaccines that controlled the epidemic in West Africa. The approach is also used in development of vaccines for other diseases of public health importance in Africa and Europe.
We want to find out whether this approach can be used in the new vaccine to protect people from COVID-19 infection. To do this, researchers need to compare the group receiving the ChAdOx1 trial vaccine, with a control group. Control groups enable researchers to compare how well the vaccine works against a substance which does not offer any protection at all against covid-19. In this trial, rabies vaccine is used as a control. We know that rabies vaccine doesn’t protect against COVID-19, but it will give participants protection against Rabies… as a benefit for taking part in the trial.
Forty volunteers will take part in the trial for the first month. This will enable researchers to confirm the safety of ChAdOx1. The study will be explained to them, and if they are healthy and willing to participate, they will sign a consent form. Each of 40 participants is given either the ChAdOx1 vaccine, or the control - in this case rabies - and this is decided randomly, or by chance, a bit like flipping a coin. But, participants will not know whether they have been given the ChAdOx1 vaccine, or whether they were given the control. This is to make sure that their behaviour is not influenced by the type of vaccine given to them.
Participants will be followed-up to closely monitor:
- Their health,
- The safety of the vaccine and whether participants experience vaccine reactions like mild fever, swelling or itchiness around the site of the injection,
- And how the participants bodies develop immunity in response to the vaccine
Because of the way it’s made, the vaccine can’t cause COVID-19 infection, but If a participant becomes infected through contact with an infected person in the community, then they will be treated according to the Ministry of Health guidelines. They will also be reminded to try to avoid infection through following government guidelines on hand-washing and social distancing.
When researchers are confident that the research can proceed, 360 new participants will be recruited. Again, chance will be used to decide which vaccine participants are given. Half the participants will be given ChAdOx1 and the other half will receive the control. Over the next 12 months, all the participants including the initial 40 volunteers, will be monitored and checked regularly. As new infections inevitably occur, researchers will be able to see whether the trial vaccine ChAdOx1 gives better protection than the control.
Collaboration between research institutions across the world is essential to develop and assess globally acceptable health innovations, and Kenyan researchers are at the forefront of collaborative efforts to develop and evaluate a vaccine which may offer protection from COVID-19.