The overarching aim of WP1 is to conduct a two arm, phase IIIb clinical trial to evaluate the safety and immunogenicity of a CHIKV vaccine in two populations: healthy adults (arm 1) and adults living with HIV under successful ART (arm 2), in Kenya and Tanzania.
The overarching aim of WP1 is to conduct a two arm, phase IIIb clinical trial to evaluate the safety and immunogenicity of a CHIKV vaccine in two populations: healthy adults (arm 1) and adults living with HIV under successful ART (arm 2), in Kenya and Tanzania.
1. Primary objectives: to assess vaccine safety in both populations and to measure humoral immunity one month post vaccination, using CHIKV neutralising antibody titres ≥150 in a validated assay as a surrogate of protection.
2. Secondary objectives: to characterise broader immunogenicity through comprehensive immune profiling (see WP2).
3. Acceptability: to evaluate acceptability among HIV positive and HIV negative participants, caregivers, healthcare providers, and Community Advisory Board (CAB)–linked community members via embedded site level surveys, generating rapid, summarised insights to optimise trial operations and support dissemination (WP5).
By integrating rigorous clinical evaluation with community centred insights, WP1 aims to advance evidence that is relevant for public health decision making across diverse settings.