Immunogenicity of Yellow Fever Vaccine 17D in Adults With Prior 17D Vaccination (NCT05859490) | Clinical Trial Compass
RecruitingPhase 1/2
Immunogenicity of Yellow Fever Vaccine 17D in Adults With Prior 17D Vaccination
United States35 participantsStarted 2023-08-01
Plain-language summary
The goal of this clinical trial is to assess the immune response to the yellow fever vaccine 17D in adults with prior 17D vaccination. The main questions this study aims to answer are:
* how does prior vaccination affect antibody responses to re-vaccination?
* how does prior vaccination affect the immune cell response to re-vaccination?
Participants will:
* have been previously vaccinated with 17D.
* be re-vaccinated with 17D.
* provide medical and travel histories.
* provide a blood sample prior to vaccination
* provide a blood sample approximately every other day for 14 days after vaccination.
* provide a blood sample approximately 28 days after vaccination.
* complete a daily diary of symptoms following vaccination for 14 days.
* report any additional symptoms after 14 days.
Who can participate
Age range
20 Years – 49 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
. Aged ≥20 to \<50 years.
. Male or female.
. In good health at the time of screening as determined by medical history, physical examination, and clinical judgement of the investigator.
. Documented history of Yellow fever vaccination 8 or more years prior. Documentation must be on a primary (not copied) vaccination card or a fully completed electronic medical record entry including date of administration and lot number administered.
. Subjects who can comply with all trial procedures and are available for the duration of follow-up.
Exclusion criteria
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
1
Neutralizing antibody titer boost following vaccination
. A clinically active infection or self-reported body temperature ≥38°C (100.4°F) within 3 days of scheduled date of vaccination (consider whether the finding is an exclusion criterion or criterion for delay of vaccination see Section 8.3).
. A known hypersensitivity or allergy to any of the trial vaccine components including eggs.
. Behavioral/cognitive impairment that, in the investigator's opinion, may interfere with the subject's ability to participate safely in the trial.
. Any history of neurologic disorder, seizure disorder or neuro-inflammatory disease.
. Any illness, or history of any illness that, in the investigator's opinion, could interfere with the trial or pose an additional risk to the subject during the trial period.
. Known or suspected impairment/alteration of immune function, including:
. Chronic use of oral steroids within 60 days prior to enrollment. Inhaled steroids are allowed.
. Receipt of parenteral steroids within 60 days prior to screening visit.