UnknownPhase 3

Booster Vaccine for Yellow Fever

750 participantsStarted 2022-05-16

Plain-language summary

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.

Who can participate

Age range

1 Year – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any child fitting the required age cohorts who has a documented record of having received a primary dose of the Institut Pasteur YF 17D vaccine between 9 and 12 months of age. * Documented evidence can be either a previous record of YF vaccination with dates in our own trial registers if the child was a previous participant or documented evidence on the Infant Welfare card. Exclusion Criteria: * Any child with a height/length for weight z-score of -3 or below. * Any child known to be immunocompromised including any child with know vertical exposure to HIV infection. * Any child with a history of serious adverse event or other contraindication to previous yellow fever vaccination. * Participants who have an acute illness including abnormal vital signs or a fever of \> 37.5°C will not be vaccinated on the day but may be invited back for rescreening when they have recovered.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with a PRNT (Plague Reduction Neutralization Testing) sero-conversion after receiving booster Yellow Fever vaccination.

Timeframe: 28 days post booster

Number of children who develop adverse events from Day 0 to D28 after receiving the booster Yellow fever vaccination

Timeframe: from Day 0 to Day 28 post booster

Trial details

NCT IDNCT05332197

SponsorLondon School of Hygiene and Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06

Contact for this trial

Ebrima K Kanteh, MD, MSc

+2207714481 ekanteh@mrc.gm

View on ClinicalTrials.gov More Yellow Fever trials