Condition: Cholera Vaccination · Sponsor: Albert B. Sabin Vaccine Institute
Background: Despite efforts to control cholera, outbreaks continue to occur in Kenya. Oral cholera vaccines (OCVs) are a critical tool in cholera prevention strategies. This study evaluates the immunogenicity of extended dosing intervals for Euvichol-S, a WHO-prequalified OCV, in a Phase IV non-inferiority trial. Overview Design: This trial is a parallel-group, open-label, randomized, non-inferiority study. It aims to compare the immune response of three dosing schedules of the Euvichol-S OCV: a standard 2-week interval, a 2-month interval, and a 12-month interval. The study will enroll 1071 participants, stratified by age into three groups (1-4 years, 5-14 years, 15+ years. The primary endpoint is the plasma vibriocidal geometric mean titer (GMT) measured two weeks after the second dose. Primary Objective: To assess and compare the immune response to Euvichol-S measured by vibriocidal GMT two weeks after the second vaccine dose across different dosing intervals. Study Sites: The study will be conducted in the Mukuru informal settlement in Nairobi, Kenya, a high-priority cholera hotspot area. The Kenya Medical Research Institute (KEMRI) will manage the study, leveraging its established relationship with the community. Study Population: Inclusion criteria include residents of Mukuru ≥1 year, who are healthy as determined by medical history and physical examination. Exclusion criteria include pregnant women, severe malnutrition, and non-HIV immunosuppressive conditions or s…
This description comes directly from the study's public registry record.
Samuel Kariuki, BVM, PhD · +254 722232467 · samkariuki2@gmail.com
Cecilia Mbae, PhD · +254 722485819 · cmkathure@gmail.com
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| KEMRI | Nairobi, Kenya | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07487077