Actively Recruiting
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
Led by Butantan Institute · Updated on 2026-04-02
700
Participants Needed
5
Research Sites
108 weeks
Total Duration
On this page
Sponsors
B
Butantan Institute
Lead Sponsor
B
Butantan Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and non-pregnant females aged 18 years or older at first vaccination
- In good health and clinically stable with no recent treatment changes or hospitalizations within 3 months prior to first vaccination
- Provide written informed consent and agree to participate in study procedures
- Willing to complete diaries, give blood samples, and attend scheduled visits
- For women of childbearing potential, negative pregnancy test before first vaccination
- Women of childbearing potential agree to use effective contraception until 30 days after second vaccination
You will not qualify if you...
- Received any vaccine (including seasonal flu) within 28 days prior to first vaccination or during study vaccination period
- Allergy or hypersensitivity to eggs, chicken proteins, squalene adjuvants, or vaccine components
- History of serious adverse reactions or anaphylaxis to any influenza vaccine
- Prior influenza A/H5 vaccination or exposure to avian influenza A/H5
- Bleeding disorders or conditions contraindicating intramuscular injection
- Received immunoglobulin, blood, or blood-derived products within 3 months before first vaccination or during study
- History of organ, bone marrow, or stem cell transplant
- History of asplenia
- Confirmed or suspected immunosuppressive or immunodeficiency conditions including HIV
- History of Guillain-Barré syndrome or other demyelinating diseases
- History of neurological disease, seizures, or severe neurological disorders
- History of malignant neoplasm (except basal cell carcinoma) unless disease-free for 5 years
- Autoimmune diseases including type 1 diabetes, liver cirrhosis, renal failure
- Significant chronic diseases worsening within 3 months prior to first vaccination
- Use of chemotherapy, radiotherapy, cytotoxic drugs, immunosuppressants in past 6 months
- Systemic corticosteroids at immunosuppressive doses in past 3 months
- Behavioral, cognitive, or psychiatric disorders interfering with participation
- Infection with HIV, hepatitis B or C
- Alcohol or drug abuse in past 12 months affecting participation
- Body mass index 35 kg/m2 or higher
- Clinically significant physical examination abnormalities
- Planned major surgery or general anesthesia during study
- Pregnant, breastfeeding or planning pregnancy during study vaccination period
- Laboratory values at screening equal or greater than grade 2
- Any condition or situation posing health risk or interfering with study participation
- Participation in another clinical trial with experimental product within past 3 months
- Institutionalized individuals or those deprived of liberty
- Related to or employed by study site staff directly involved in the trial
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centro de Terapias Avançadas E Inovadoras - Ct Terapias/Ufmg
Belo Horizonte, Minas Gerais, Brazil, 30750-140
Not Yet Recruiting
2
Plátano Centro de Pesquisa Clínica LTDA
Recife, Pernambuco, Brazil, 52011-040
Actively Recruiting
3
Fundação Faculdade Regional de Medicina de São Jose do Rio Preto - (Centro integrado de Pesquisa CIP)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Not Yet Recruiting
4
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
Not Yet Recruiting
5
Centro de Pesquisas Clínicas do Hospital das Clínicas da FMUSP
São Paulo, Brazil, 05403-010
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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