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

Yellow Fever Vaccination Reaction Clinical Trial

Official title: An Exploratory, Pilot Study of the Safety and Immunogenicity of Reduced Doses of the US Yellow Fever Vaccine

Status Completed

Clinical Trial 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) Yellow Fever vaccine (YF-VAX).

Clinical Trial Description

Up to 150 individuals will be screened in order to randomize 90 eligible individuals to one of three groups: Group 1- YF-VAX® standard dose 0.5 mL SQ = 30 subjects; Group 2-0.10 mL (1/5th) SQ = 30 subjects; Group 3-0.05 mL (1/10th) SQ = 30 subjects. ;

Related Conditions & MeSH terms

• Fever
• Yellow Fever
• Yellow Fever Vaccination Reaction

• NCT number: NCT05374317
• Study type: Interventional
• Source: US Army Medical Research Institute of Infectious Diseases
• Status: Completed
• Phase: Phase 4
• Start date: June 7, 2021
• Completion date: November 2, 2022