AP09CP01 is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study which is conducted in Australia. The main purpose of this research study is to evaluate the safety, side effects, and immune response of APL-10456-Vaccine, a Rhinovirus (RV) Vaccine, when compared with a placebo in Younger and Older Healthy Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
144
3 cohorts are planned for Part A and Part B
Placebo (a saline) is comparator to study vaccine
To evaluate the safety and reactogenicity of APL-10456-Vaccine in healthy volunteers (HVs)
Collecting AEs in Part A: HVs from 18 to 54 years of age, inclusive and Part B: HVs ≥ 55 years of age. Incidence, severity, relationship and outcome of Adverse Events (AE)
Time frame: Through Study Completion (Approx 365 days)
To assess the immunogenicity of a single dose of APL-10456-Vaccine in Part A and B, and a prime/boost administration of APL-10456-Vaccine in Part B
serotype-specific anti-APL-10456 antibody (IgG) titers and seroconversion rates in serum samples
Time frame: Day 8 and Day 29 in Part A and approximately monthly visits up to Day 365 in Part B
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