Immunogenicity of Yellow Fever Vaccine 17D in Adults With Prior 17D Vaccination
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-49
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
17D
Biological/VaccineVaccine administration in subjects previously vaccinated with 17D.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Vaccination armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neutralizing antibody titer boost following vaccination
four-fold rise in neutralization antibody titer before and after vaccinatioin
Time frame
28 days2
vaccine viremia following vaccination
detection of vaccine virus in subject blood
Time frame
14 daysSecondary outcomes
1
CD4+ immune cell response to vaccination
Frequency of CD4+ cell populations on day 0, 2, 8, 14, and 28 post vaccination
Time frame
28 daysOther outcomes
1
CD8+ immune cell response to vaccination
Frequency of CD8+ cell populations on day 0, 2, 8, 14, and 28 post vaccination
Time frame
28 days2
cytokine response to vaccination
Cytokine levels measured on days 0, 1, 2, 8, 14, and 28 days post vaccination
Time frame
28 days3
vaccine virus titer
quantity of vaccine virus in vaccine vial on vaccination day 0
Time frame
1 day4
Memory B cell response to vaccination
YFV specific memory B cell frequency on days 1, 2, 8, 14 and 28 days post vaccination
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov