Yellow Fever Vaccine Booster Trial in Children- a Phase 3 Clinical Trial to Establish Safety and Immunogenicity of Repeated YF Vaccination in Healthy Gambian Children of Different Ages (BoVY)

NCT05332197 Phase 3 UNKNOWN

This is a phase III trial on Children. The investigators will enroll a total of 750 participants in Fajikunda Health Center (Gambia) The aims of the study are * To describe the safety and immunogenicity of a booster dose of a licensed yellow fever vaccine administered to 3 different age cohorts of children, following a documented primary dose of a yellow fever vaccine administered at nine-months of age. * To characterise the rate of yellow-fever PRNT sero-reversion (seropositive to seronegative) over a period of 9 months to 8 years following a single primary dose of yellow fever vaccine administered to Gambian infants at nine months age. * To profile the immune response to the booster dose of YF vaccine in order to explore underlying mechanisms for longevity of vaccine-induced antibody.

Details

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	Phase 3
Status	UNKNOWN
Enrolment	750
Start date	2022-05-16
Completion	2023-09

Conditions

• Yellow Fever

Interventions

• 17D Yellow fever vaccine

Primary outcomes

• Number of participants with a PRNT (Plague Reduction Neutralization Testing) sero-conversion after receiving booster Yellow Fever vaccination. — 28 days post booster
  Children will receive Yellow fever booster vaccination and different intervals of the primary dose and their blood will be collected 28days after the booster and tested for seroconversion to PRNT.
• Number of children who develop adverse events from Day 0 to D28 after receiving the booster Yellow fever vaccination — from Day 0 to Day 28 post booster
  After receiving the booster, children will be reviewed for adverse events 30 minutes to 1hour after the vaccination and followed up through home visits daily for 3days. Then they will be advised to come to the site for assessment if they develop an adverse event up to 28days after vaccination