This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
A total of 30 subjects will be randomly assigned to one of 3 different arms in order to evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with or without adjuvant, and the outcome compared to a placebo control group. For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following the same schedule with a placebo solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Intramuscular doses of 0.5 mL
Intramuscular doses of 0.5 mL
Intramuscular doses of 0.5 mL
WRAIR Clinical Trial Center (CTC)
Silver Spring, Maryland, United States
Occurrence and severity of adverse events
Number and severity of local site injection and general adverse events will be collected and compared between the different arms of the study
Time frame: until Day 56
Evaluation of antigen-specific antibodies between baseline (D0) and after injection for all groups.
Immunogenicity will be evaluated after the first and second injection and compared to pre-immune levels
Time frame: until Day 56
Evaluation of antigen-specific antibodies between subjects receiving the candidate vaccine with and without adjuvant
Immunogenicity will be compared between subjects receiving candidate vaccine with and without adjuvant after the first and second injection
Time frame: until Day 56
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