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 range20 Years – 49 Years
SexALL
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
✕. 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.
What they're measuring
1
Neutralizing antibody titer boost following vaccination
✕. 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.