Serrana

Researchers are evaluating the safety and immune response of two versions of a monovalent influenza vaccine candidate A (H5N8) developed by Instituto Butantan. This vaccine is inactivated, fragmented, and combined with an adjuvant called IB160. The study is designed as a Phase I/II randomized, double-blind, placebo-controlled trial involving adults and older adults to prepare for potential outbreaks or pandemics of avian influenza A/H5 in humans. Participants will receive one of three interventions: a 7.5 mcg dose of the vaccine with IB160 adjuvant, a 15 mcg dose of the vaccine with IB160 adjuvant, or a placebo (phosphate buffered saline). The study monitors safety by recording local and systemic adverse events and reactions within 7 days after each vaccination. Immunogenicity is assessed by measuring seroprotection and seroconversion rates 21 days after the second dose. During the study, participants will be closely monitored through scheduled visits and blood sample collections. Researchers track adverse reactions, their intensity, duration, and any medication used for treatment. Participants complete diaries to report symptoms and side effects. The main outcomes focus on the percentage of participants experiencing adverse events and the vaccine's ability to trigger an immune response after vaccination, with follow-up assessments conducted throughout the study period.