Yellow Fever Clinical Trial
Official title:
Randomized, Double Blind, Controlled Phase I Trial of the Safety, Tolerability,and Immunogenicity of Graded Doses of XRX-001 Yellow Fever 17D, Inactivated Vaccine, Alum Adsorbed in Healthy Adults.
The Phase 1 trial is a single-center, randomized, double blind, placebo-controlled,
dose-ranging out-patient study designed to provide the first clinical data on the safety,
tolerability and immunogenicity of XRX-001 inactivated yellow fever vaccine in 60 healthy
male and female volunteers, 18-49 years of age. Subjects will receive two inoculations of
one of two dose levels of XRX-001 vaccine. A control group will receive placebo.
Safety will be determined by the incidence and severity of adverse events in each treatment
group and in the combined cohorts in the double blind treatment period up to 42 days
post-vaccination. Subjects will also be followed-up at 3, 6 and 12 months to determine
severe adverse events (SAEs) and changes in health status.
Efficacy will be assessed by neutralizing antibody response to the vaccine. The co-primary
immunogenicity endpoints will be the dose-response analysis of seroconversion rates
(fourfold or greater increase in neutralizing antibody titer between baseline and Day 42)
and of the 50% plaque reduction neutralization test (PRNT50) geometric mean titers (GMT) at
Day 42.
Secondary immunogenicity endpoints will include:
1. The seroconversion rates and GMT neutralizing antibody titers for all dose groups
combined on Days 21 and 42.
2. The reverse cumulative distribution curve of antibody titers on Days 21 and 42 for each
dose group and for all dose groups combined
3. The duration of antibody titers displaying the seroconversion rate and GMT across all
time-points to Month 12, by treatment group and for both dose groups combined.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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