Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine in adults in Kenya: a phase 1/2 single-blind, randomised controlled trial.

Background: There are limited data on the immunogenicity of coronavirus disease 2019 (COVID-19) vaccines in African populations. Here we report the immunogenicity and safety of the ChAdOx1 nCoV-19 (AZD1222) vaccine from a phase 1/2 single-blind, randomised, controlled trial among adults in Kenya conducted as part of the early studies assessing vaccine performance in different geographical settings to inform Emergency Use Authorisation.

Methods: We recruited and randomly assigned (1:1) 400 healthy adults aged ≥18 years in Kenya to receive ChAdOx1 nCoV-19 or control rabies vaccine, each as a two-dose schedule with a 3-month interval.

Fourth Controlled Human Infection Model (CHIM) meeting - CHIMs in endemic countries, May 22-23, 2023.

Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used.

[A global core outcome measurement set for snakebite clinical trials].

Background: Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation.

Method: A globally representative group of key stakeholders came together to reach consensus on a globally relevant set of core outcome measurements. Outcome domains and outcome measurement instruments were identified through searching the literature and a systematic review of snakebite clinical trials.

A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies.

Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during recent PHEs. Design features of these trials may have implications for engagement and/or informed consent processes.

A global core outcome measurement set for snakebite clinical trials.

Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. A globally representative group of key stakeholders came together to reach consensus on a globally relevant set of core outcome measurements. Outcome domains and outcome measurement instruments were identified through searching the literature and a systematic review of snakebite clinical trials.

Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt.

Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are "controlled" by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases.

What Does "Good" Community and Public Engagement Look Like? Developing Relationships With Community Members in Global Health Research.

Community and public engagement (CPE) is increasingly becoming a key component in global health research. The National Institute for Health Research (NIHR) is one of the leading funders in the UK of global health research and requires a robust CPE element in the research it funds, along with CPE monitoring and evaluation. But what does "good" CPE look like? And what factors facilitate or inhibit good CPE? Addressing these questions would help ensure clarity of expectations of award holders, and inform effective monitoring frameworks and the development of guidance.

Always leave the audience wanting more: An entertaining approach to stimulate engagement with health research among publics in coastal Kenya through 'Magnet Theatre'.

Magnet Theatre (MT), a form of participatory community theatre, is one of several public engagement approaches used to facilitate engagement between KEMRI-Wellcome Trust Research Programme (KWTRP) researchers and public audiences in Coastal Kenya. We describe how we used MT as an entertaining forum where audiences learn about research, and where researchers learn about how the public views research. Drama scripts depicting community interaction with different aspects of research were developed iteratively with research staff, a theatre company and community members.

Proceedings of an expert workshop on community agreement for gene drive research in Africa - Co-organised by KEMRI, PAMCA and Target Malaria.

Gene drive research is progressing towards future field evaluation of modified mosquitoes for malaria control in sub-Saharan Africa. While many literature sources and guidance point to the inadequacy of individual informed consent for any genetically modified mosquito release, including gene drive ones, (outside of epidemiological studies that might require blood samples) and at the need for a community-level decision, researchers often find themselves with no specific guidance on how that decision should be made, expressed and by whom. Target Malaria, the Kenya Medical Research Institute and the Pan African Mosquito Control Association co-organised a workshop with researchers and practitioners on this topic to question the model proposed by Target Malaria in its research so far that involved the release of genetically modified sterile male mosquitoes and how this could be adapted to future studies involving gene drive mosquito releases for them to offer reflections about potential best practices.

Effective engagement and involvement with community stakeholders in the co-production of global health research.

argue that small changes as well as larger system-wide changes can strengthen citizens’ contribution to knowledge in health research

Evolution of a programme to engage school students with health research and science in Kenya.

Facilitating mutually-beneficial educational activities between researchers and school students is an increasingly popular way for research institutes to engage with communities who host health research, but these activities have rarely been formally examined as a community or public engagement approach in health research. The KEMRI-Wellcome Trust Research Programme (KWTRP) in Kilifi, Kenya, through a Participatory Action Research (PAR) approach involving students, teachers, researchers and education stakeholders, has incorporated 'school engagement' as a key component into their community engagement (CE) strategy. School engagement activities at KWTRP aim at strengthening the ethical practice of the institution in two ways: through promoting an interest in science and research among school students as a form of benefit-sharing; and through creating forums for dialogue aimed at promoting mutual understanding between researchers and school students.

Engaging religious leaders to support HIV prevention and care for gays, bisexual men, and other men who have sex with men in coastal Kenya.

In Kenyan communities, religious leaders are important gatekeepers in matters of health and public morality. In a context that is generally homophobic, religious leaders may aggravate or reduce stigmatization of sexual minorities such as gay and bisexual men, and other men who have sex with men (GBMSM). Literature indicates mixed results in efforts to encourage religious leaders to work effectively and sensitively with issues regarding HIV and sexuality.