RecruitingPhase 1Phase 2NCT06842173

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

Sponsor

Butantan Institute

Enrollment

700 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Avian Influenza A Virus

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg, a biological treatment called Monovalent influenza vaccine type A (H5N8) 15 mcg, and others for people with avian influenza a virus. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMonovalent 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)

BIOLOGICALMonovalent influenza vaccine type A (H5N8) 15 mcg

Monovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total)

OTHERPlacebo

Phosphate buffered saline (PBS) (0.5 mL/dose).

Locations(5)

Centro de Terapias Avançadas E Inovadoras - Ct Terapias/Ufmg

Belo Horizonte, Minas Gerais, Brazil

Plátano Centro de Pesquisa Clínica LTDA

Recife, Pernambuco, Brazil

Fundação Faculdade Regional de Medicina de São Jose do Rio Preto - (Centro integrado de Pesquisa CIP)

São José do Rio Preto, São Paulo, Brazil

Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preta da Universidade de São Paulo - (Centro de Pesquisa Clínica - S)

Serrana, São Paulo, Brazil

Centro de Pesquisas Clínicas do Hospital das Clínicas da FMUSP

São Paulo, Brazil

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NCT06842173