Immunogenicity of Yellow Fever Vaccine 17D in Adults With Prior 17D Vaccination

NCT05859490 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY00025307
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Yellow Fever; Immunization; Infection

Keywords

17D; vaccination; immunity

Outcome Measures

Primary Outcomes (2)

• Neutralizing antibody titer boost following vaccination

  four-fold rise in neutralization antibody titer before and after vaccinatioin

  28 days

• vaccine viremia following vaccination

  detection of vaccine virus in subject blood

  14 days

Secondary Outcomes (1)

• CD4+ immune cell response to vaccination

  28 days

Other Outcomes (4)

• CD8+ immune cell response to vaccination

  28 days

• cytokine response to vaccination

  28 days

• vaccine virus titer

  1 day

Study Arms (1)

Vaccination arm

EXPERIMENTAL

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

Biological: 17D

Interventions

17D BIOLOGICAL

Vaccine administration in subjects previously vaccinated with 17D.

Also known as: YFVax

Vaccination arm

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Receipt of immunoglobulins and/or any blood products within the 3 months prior to enrollment or planned receipt during the trial.
• Receipt of immunostimulants within 60 days prior to screening visit
• Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months of enrollment.
• Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
• Hepatitis C virus infection.
• Genetic immunodeficiency.
• History of splenic or thymic dysfunction.
• Any serious chronic or progressive disease as assessed by the investigator (eg, neoplasm, hematologic malignancies, insulin dependent diabetes; cardiac, renal, or hepatic disease).

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Yellow Fever; Infections

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• William Messer, MD PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Messer, MD PhD

CONTACT

503-494-2185; messer@ohsu.edu

Sarah Siegel, PhD

CONTACT

541-60-0798; siegels@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All subjects receive the same intervention.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 16, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: For up to 5 years after the completion of the study.
• Access Criteria: The PI will review all sample and data requests. A request will include a scope of work and justification for the work. All approved requests will be conducted under an M/DTA.

Locations

US (1)