SERVE-Kenya Study

Tittle: Social, Ethical and Regulatory implications of conducting a malaria Vaccine Efficacy trial in a human infection study in Kenya.

Duration: 36 months

Background

Malaria remains an important public health problem in many LMICs, including Kenya – necessitating alternative prevention and control strategies. Malaria human infection studies (HIS) – trials that involve the deliberate infection of healthy volunteers with malaria parasites to assess the efficacy of potential vaccine and drug candidates and to understand the innate and acquired protection against malaria parasites – have become an important approach to fast-track the development of a malaria vaccine. The KEMRI-Wellcome Trust Research Programme (KWTRP) has developed expertise in setting up and running research on malaria HIS, with two completed and two planned in the coming months. One of the planned studies is a Phase IIb malaria vaccine efficacy trial within a HIS funded by the EDCTP. While all scientific proposals at KWTRP are carefully reviewed by national and international science and ethics review bodies and are supported by a well-developed local community engagement platform, research to understand the social, ethical and regulatory issues for HIS from a grounded perspective is in early stages of development, especially in LMICs.

Given the particular opportunities provided by the KWTRP’s experience in running HIS, expertise in embedded social science research and the presence of a well-established community engagement platform, we plan to conduct a social science study within the HIS-based Phase IIb malaria vaccine trial.

Aims and purpose

We are funded by EDCTP to contribute to the development of locally responsive policies on the ethical conduct of malaria vaccine efficacy studies involving the use of a HIS in Kenya. Specifically, we first aim to explore the social, ethical and regulatory issues associated with an HIS-based malaria vaccine efficacy trial. Given the relative novelty of HIS, particularly from a wider public or community perspective, we then aim to feed the empirical findings into a series of in-depth deliberative engagement processes to explore the informed views and values of different community and research-HIS stakeholders around core emerging social and ethical issues. Drawing on the outputs of the deliberative processes and the wider international ethics literature, we will propose recommendations on the nature of responsive policies for the ethical conduct of malaria vaccine HIS.

Methodology

Overall, data will be collected from a range of HIS stakeholders, including HIS participants and their families, community members, HIS research team, ethics committees, regulatory authorities and policy makers through surveys, interviews, group discussions, participatory workshops, observations and document review. Data collection will primarily be undertaken at the sites for the main planned malaria HIS, namely: Ngerenya sublocation in Kilifi county in Kenya. Some key informants will be based in Nairobi or other sites in Kenya (i.e. ethics review committees, regulatory authorities, and health policy stakeholders).

Expected benefits

Findings from this study will contribute towards the development of recommendations around the nature of responsive policies for the ethical conduct of malaria HIS, including those involving malaria vaccine challenge models. These will be particularly useful for HIS researchers, ethics communities and regulatory authorities towards supporting the ethical conduct of HIS in Kenya.

Funding
The project has been funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) through a Career Development Fellowship to Dr. Primus C. Chi (Grant reference: TMA2019CDF-2751)

Investigators

Dr. Primus Che Chi, Ms. Esther Awuor Owino, Dr. Melissa Kapulu, Prof. Vicki Marsh, and Dr. Dorcas Kamuya