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Phase I
- Limited number of volunteers, investigation of serious adverse effects, and dose escalation/determination.
- Phase 1 is the clinical research stage aimed at demonstrating the safety of the vaccine candidate. It involves a limited number of healthy volunteers to investigate the vaccine's pharmacokinetic profile (disposition within the body), toxicity (adverse effects), and pharmacological actions.
- Studies are conducted with a small cohort of healthy volunteers, typically ranging from 20 to 80 participants.