1. What is the ChAdOx1 Vaccine Trial? This trial aims to assess whether the ChAdOx1 vaccine is safe, effective and provides immunity against COVID-19 in adults aged 18 years and above.
2. How long will the vaccine trial run? After starting, the trial will run for 24 months.
3. Why conduct the trial in Kenya? A vaccine that works in one population does not necessarily work in all populations, therefore it’s essential to find out whether the trial vaccine works among Kenyan populations to ensure that Kenyans can benefit from the vaccine if it proves to be successful.
4. How will Kenya benefit from participating in this vaccine trial? We need to determine if the vaccine works in our population for GOK’s investment decision. The Kenyan government, through MOH, can negotiate with vaccine manufacturers and donors for subsidized vaccine availability to Kenyans. The effective distribution of vaccines is to be agreed on globally. Global vaccine initiatives like GAVI (the Vaccine Alliance) are in discussions with governments to reach agreements.
5. Where will the trial take place? The initial recruitment site will be Kilifi and recruitment outside Kilifi County will be responsive to the epidemic and may include Mombasa.
6. Why is the trial being conducted in Kilifi? Effective follow-up is very critical in a phase 1 and 2 trial, and this follow up is more accessible in a Demographic Surveillance System, which we have in Kilifi.
7. How many people will be recruited for this trial? 400 adult volunteers will be recruited for both Phase 1b and Phase 2.
8. Who can participate in this trial? This trial will only enrol frontline workers in key service areas such as healthcare workers, truck drivers, and security personnel among others, over the age of 18 years.
9. What are the phases of this vaccine trial? The study and recruitment involve two phases of study.
10. Is this vaccine safe? The potential risk to participants is low and is mainly related to collecting blood samples and vaccination.
11. Is this Vaccine safe? This trial vaccine has so far been given to over 8,000 volunteers in the UK, South Africa and Brazil, and no significant safety concerns have been seen.
12. The vaccine trial was stopped in other countries, why are you testing it in Kenya? The trial was temporarily paused when one volunteer developed an unexpected illness. Trial pausing is a standard procedure for an independent investigation of illness in a trial volunteer. Pausing the trial means no recruitment of participants happens in Kenya.
13. Has the vaccine trial been completely stopped? Following independent reviews of the cause of the trial volunteer’s illness and finding that it may not have been related to the trial vaccine, the Data Safety and Monitoring Board (DSMB), has allowed the trial to proceed.
14. What is a DSMB? This is an independent committee made up of experts in biomedical research. Members from different parts of the world are the committee members. Their work is to closely monitor safety data coming out of clinical trials. The DSBM for this Vaccine trial includes expert scientists from Kenya. A continued update regarding all safety matters in the international trials is provided to the Kenyan approving authorities.
15. How will you ensure the safety of participants? Participants will be closely monitored during the trial to ensure that they are healthy, and any effects of the vaccine are addressed. After getting the trial vaccine, the follow up will be up to 12 months.
16. Are people being paid to participate in this vaccine trial? Individuals who agree to volunteer in this trial will be reimbursed for costs of participation such as a refund of travel costs. We will compensate other study-related costs based on a standardized rate per our payment guidelines. Reimbursing volunteer costs is an ethical requirement in research.
17. What are the possible benefits for those participating? Participants will benefit from knowledge of their general health status, including whether they are infected with SARS-CoV-2 (the virus that causes COVID-19).
18. Will participants access this vaccine for free if it is found effective? If global data demonstrate the safety and efficacy of this trial vaccine, the control group that received a rabies vaccine will be offered the ChAdOx1 nCOV-19 vaccine, once all appropriate protocols have been followed.
19. Who develops this vaccine? Researchers from the University of Oxford, UK, in partnership with AstraZeneca, developed the vaccine.
20. How does the research team share the trial results with the public? Provide summaries of the outcome of the trial during community meetings. In addition, information to all stakeholders will be provided through the relevant communication and engagement channels.
21. What is KWTRP’s capacity for this trial? They have conducted large vaccine trials, including Malaria RTSS and Ebola, over the last 2 decades.
22. When does the trial start? The provided date is prospective and not definite. It is a procedural requirement to indicate the (intended) start date when developing trial/study protocols. After obtaining all regulatory requirements, that is when the actual start date occurs. We have obtained regulatory approvals from KEMRI’s Scientific Ethics Review Committee, the Pharmacy and Poisons Board, and NACOSTI. We are currently awaiting additional approvals from the relevant local approving authorities at the study sites. After obtaining the approvals and engaging/informing participants about the trial, then the vaccine trial starts.
23. Is the Vaccine candidate in the Kenyan trials the same as the one in the UK and USA? Kenya will be using the same vaccine candidate under trial in the UK, Brazil, and South Africa. Phase III trials in South Africa are currently using the same.
24. How the knowledge gained from the Kenya trials is used? The knowledge gained from this clinical trial is relevant in informing us how this vaccine performs in our population. The main reason for clinical trials is to improve new and existing health interventions.
25. How to ensure transparency in trial communication to the public? As it is standard practice in the conduct of all clinical trials (not just this trial)– it is bound by various regulatory policies, guidelines and requirements in the various stages of development and conduct of clinical trials.
These requirements include publicity and information sharing to the general public and potential (and actual study) participants. Part of the publicity and information sharing (required) includes publishing the protocol.
We have continued to do this and update the highlights on our website and social media platforms. We shall continue providing information through our website and social media updates throughout the trial.
26. What is the actual monetary reimbursement (compensation) rate for those who participate – what are the usual rates in such an exercise? As a result of participation, the compensation is fixed so that volunteers are not out of pocket.
The rate depends on factors like transportation, participation time, and other volunteer expenses.
27. Who is funding this trial? The trial is being funded by the Welcome Trust and Oxford University as the sponsor.
28. When will the trial results be available? While we have ample safety and efficacy information, determining the vaccine’s disease-preventing capabilities remains uncertain.. This will depend on the pandemic, as cases fall it’s harder to demonstrate that the vaccine prevents disease.
