Population
Preclinical models: male BALB/c mice (4-6 weeks old) and New Zealand White rabbits (1:1 female to male ratio).
Comparison
Inactivated, purified EV71 candidate vaccine… vs Phosphate-buffered saline with Tween 80, normal…
Design
Preclinical
Follow-up
Up to 120 days (mice) and 56 days (rabbits)
Authors
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Supports advancement to Phase 1 human trials; leaves open clinical efficacy and durability in patients.
An inactivated EV71 candidate vaccine with aluminum hydroxide adjuvant demonstrated strong immunogenicity and a favorable safety profile in preclinical models, enabling Phase 1 clinical trials.
Hwa et al. (2013) studied this question.
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