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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
88
Administered subcutaneously once.
United States Army Medical Research Institute of Infectious Diseases
Frederick, Maryland, United States
Adverse Events
Incidence of Adverse Events of fractional doses vs standard dose of YF-VAX as determined by subject diary and clinical history and physical examination. The incidence of solicited and unsolicited adverse events will be analyzed.
Time frame: Up to one year following vaccination.
Neutralizing Antibody Response
Compare the neutralizing antibody response rate and mean of each ARM as determined by PRNT obtained at several time points. Fractional doses will be compared to the standard dose of YF-VAX. The primary data point is post vaccination day 28.
Time frame: Up to one year following vaccination.
Viremia
Compare the incidence and level of viremia and mean viral load by RT-PCR (copies/mL) of fractional doses vs standard dose.
Time frame: First 14 days following vaccination.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.