ChAdOx1 nCOV-19 Vaccine Trial – Frequently Asked Questions about the Trial

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 which works in one population does not necessarily work in all populations, therefore it’s important 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 know if this vaccine works in our population, for GoK to decide whether to invest in the vaccine or not. The government of Kenya, through MoH, will be able to initiate discussions with vaccine manufacturers and donors, to find ways of making this vaccine accessible to Kenyans at a subsidized cost. Globally, there are discussions between global vaccine initiatives such as GAVI (the Vaccine Alliance) and governments, to reach an agreement on how effective vaccines will be distributed among citizens.

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 easier in a Demographic Surveillance System, which we have in Kilifi.

7. How many people will be recruited into this trial? A total of 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, security personnel among others, over the age of 18 years.

9. What are the phases of this vaccine trial? The study involves two phases. In the first phase 40 participants will be recruited; followed by 360 volunteers recruited in the second phase of the study.

10. Is this vaccine safe? 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 8000 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 which allows an independent body to investigate the cause of an illness that has occurred in a trial volunteer. While the trial was paused, no participant recruitment was happening 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 with 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. The committee members are drawn from different parts of the world. Their work is to closely monitor safety data coming out of clinical trials. The DSBM for this Vaccine trial includes expert scientists from Kenya. The Kenyan approving authorities continue to be updated regarding all safety matters in the international trials.

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. They will be followed up for 12 months after getting the trial vaccine.

16. Are people being paid to participate in this vaccine trial? Individuals who agree to volunteer in this trial will be reimbursed costs of participation such as refund of travel costs. They will also be compensated for other study related costs they may incur, on a standardized rate as outlined in our payment guidelines. Reimbursing volunteer costs is an ethical requirement in research.

17. What are the possible benefits for those participating? Participants will benefit by 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 demonstrates 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 developed this vaccine? The vaccine was developed by researchers at the University of Oxford, UK in partnership with AstraZeneca.

20. How will the trial results be shared with the public? Summaries of the outcomes of the trial will be provided during community meetings in the areas from which participants are recruited. In addition, information to all stakeholders will be provided through the relevant communication and engagement channels.

21. What capacity does KWTRP have to conduct this trial? KWTRP researchers have conducted large vaccine trials over the last 2 decades such as a Malaria RTSS vaccine trial and Ebola vaccine trial.

22When will the trial start? The date provided for the start of the trial is prospective and not a definite date. It is a procedural requirement to indicate (intended) start date when developing trial/study protocols. However, the actual start date occurs only when all regulatory requirements have been obtained. Currently we have obtained regulatory approvals from the KEMRI Scientific Ethics Review committee, the Pharmacy and Poisons Board, and the National Commission for Science, Technology and Innovation (NACOSTI). We are currently awaiting additional approvals from the relevant local approving authorities at the study sites. The vaccine trial will start once these approvals are obtained, and participants are engaged/informed about the trial.

23Is the Vaccine candidate in the Kenyan trials the same as the one in the UK and US? The vaccine candidate under trial in the UK, Brazil, and South Africa is the same as what will be used in Kenya and is the same currently in use in the phase III trials in South Africa.

24How will the knowledge gained from the Kenya trials be used? The knowledge gained from this clinical trial will be relevant in informing us how this vaccine performs in our population. This is the main reason for clinical trials, to use the knowledge for the improvement of new and existing health interventions.

25. How will you ensure transparency in trial communication to the public  As is standard practice in conduct of all clinical trials (not just this trial)– we are 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 both to the general public and to potential (and actual study) participants. Part of the publicity and information sharing (required) includes publishing the protocol when it is being submitted for review – and updating the published version every time amendments are done. We have continued to do this and in addition, updating 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 will participate – what are your usual rates in such an exercise? The compensation is fixed so that volunteers are not out of pocket as a result of their participation. The rate is dependent on various factors including transportation, the time required to participate, and other expenses incurred by the volunteer.

27. Who is funding this trial? The trial is being funded by the Wellcome Trust and Oxford University as the sponsor.

28. When do we expect results for this trial? We already have a lot of information on safety and how well the vaccine works, it’s unclear when we will determine if the vaccine prevents disease. This will depend on the pandemic, as cases fall it’s harder to demonstrate that the vaccine prevents disease.