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Article History

Received: 8 April 2025

Accepted: 3 February 2026

First Online: 13 February 2026

Declarations

:

: This study protocol has been reviewed and approved by Rwanda National Ethics Committee (reference RNEC589/2024) and the University of Birmingham (reference ERN_3084). The study will be conducted in accordance with the principles of the Declaration of Helsinki and relevant regulations of the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice. All amendments to the protocol will be discussed with RNEC. The sponsor is University of Birmingham, who can be contacted on adm-researchgov@adf.bham.ac.uk and provide indemnity or compensation for harm arising as a consequence of the research subjects’ participation in the trial. All participants will provide documented informed consent to participate. Participation in the trial is strictly voluntary, and withdrawal can occur at any point in the trial.

: There was no public involvement in development of the research question or study design. However, the planned semi-structured interviews or focus groups with study participants and healthcare workers will address PPI aspects to the project.

: Not applicable.

: CAG has worked as a Principal Investigator with many commercial vaccine manufacturers including, and not restricted to, AstraZeneca, Pfizer/BNT, Moderna, Johnson&Johnson, CureVac, Novovax, Valneva, Gritstone. None of these present a conflict of interest in this study but are declared in the spirit of full transparency. All other others have no competing interests to declare.