NCT06842173

Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults

Randomized, Double-Blind, Placebo-Controlled Phase I/II Clinical Trial To Evaluate The Safety And Immunogenicity Of The Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) From Instituto Butantan, In Adults And The Older Adults

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to demonstrate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults, to be developed for situations of pandemic, epidemic or outbreak of avian type A/H5 in humans, in the context of pandemic preparedness.

Detailed description

This is a clinical trial (randomized, double-blind, placebo-controlled Phase I/II) to evaluate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults. Safety will be assessed by the frequency (n, %) of participants with solicited (local and systemic) and unsolicited adverse events reported within 7 days post each vaccination; as well as the frequency of adverse reactions post causality evaluation. Immunogenicity will be assessed by seroprotection and seroconversion rates in the 21 days after the second dose.

Conditions

• Avian Influenza A Virus

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg	Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total)
BIOLOGICAL	Monovalent influenza vaccine type A (H5N8) 15 mcg	Monovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total)
OTHER	Placebo	Phosphate buffered saline (PBS) (0.5 mL/dose).

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-08-10
• Completion: 2027-10-10
• First posted: 2025-02-24
• Last updated: 2026-04-02

Locations

5 sites across 1 country: Brazil