Yellow Fever Vaccine 17D Immunogenicity for Yellow Fever

Overseen By Sarah Siegel, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Oregon Health and Science University

Must not be taking: Oral steroids, Immunoglobulins

Disqualifiers: Neurologic disorder, Immunodeficiency, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

35 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

William Messer, MD PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

Adults aged 20-49 who are in good health and have been previously vaccinated with the yellow fever vaccine (17D) at least 8 years ago. They must be able to follow trial procedures, provide a detailed medical history, and not plan to travel to yellow fever endemic areas during the trial.

Inclusion Criteria

I am either male or female.

I am between 20 and 49 years old.

I have an original record of a Yellow fever vaccination given over 8 years ago.

Exclusion Criteria

I am able to have children, sexually active, and haven't used birth control for 2 months.

Behavioral/cognitive impairment that, in the investigator's opinion, may interfere with the subject's ability to participate safely in the trial

I have a history of neurological disorders or seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Vaccination

Participants receive a standard dose of the yellow fever vaccine 17D (YFVax®), 0.5mL suspension in normal saline administered subcutaneously once.

1 day

1 visit (in-person)

Monitoring

Participants provide blood samples approximately every other day for 14 days after vaccination and complete a daily diary of symptoms following vaccination for 14 days.

14 days

Multiple visits (in-person)

Follow-up

Participants provide a blood sample approximately 28 days after vaccination and report any additional symptoms after 14 days.

28 days

1 visit (in-person)

Treatment Details

Interventions

• 17D

Trial Overview The study is testing how well adults respond to a re-vaccination of the yellow fever vaccine (17D). It looks at antibody responses and immune cell reactions after getting another dose of the same vaccine they received before.

Participant Groups

Group I: Vaccination arm Experimental Treatment 1 Intervention

Participants will receive a standard dose of of the yellow fever vaccine 17D (YFVax(r)), 0.5mL suspension in normal saline administered subcutaneously once.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+