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Study of the Safety and Immunogenicity of Reduced Doses of the US Yellow Fever Vaccine

NCT05374317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-07

Study results available
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Summary

This is an open-label, randomized, exploratory study to evaluate the human immune response to reduced subcutaneous (SQ) dosing of Yellow Fever vaccine compared to the standard FDA approved subcutaneous vaccination dose. The current dose of the US FDA licensed Yellow Fever vaccine is approximately 55,000 plaque-forming unit(s) (PFU) in 0.5 mL administered SQ. Using the licensed dosage as standard, investigators are evaluating reduced doses of 1/5th (0.10 mL) and 1/10th (0.05 mL) standard Yellow Fever vaccine (YF-VAX).

Conditions

  • Yellow Fever Vaccination Reaction

Interventions

BIOLOGICAL

Yellow Fever Vaccine

Administered subcutaneously once.

Sponsors & Collaborators

  • US Army Medical Research Institute of Infectious Diseases

    lead FED

Principal Investigators

  • Phillip R Pittman, M.D., M.P.H. · US Army Medical Research Institute of Infectious Diseases

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2022-11-02
Completion
2022-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05374317 on ClinicalTrials.gov