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Tests treatment safety and results for Avian Influenza A Virus
Official title Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
ClinicalTrials.gov ID: NCT06842173
What this study is testing
What is Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg?
Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg is an investigational medicine, being studied as a potential treatment for avian influenza a virus.
Also referred to as Avian Flu vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Males and non-pregnant females aged ≥ 18 years at the time of the first study vaccination.
- Be in good health and clinically stable (defined as having no pre-existing health condition or having a pre-existing health condition that has not...
- Agree to participate in the study and provide written informed consent prior to the initiation of any study procedures.
- Be able and willing to comply with all study procedures, including completing Participant Diaries, collecting blood samples, and being available for...
- For females of childbearing potential, have a negative pregnancy test prior to the first study vaccination.
You likely can't join if
- Having received any vaccine (including seasonal influenza) 28 days prior to the date of the first study vaccination or having any vaccination in the...
- Known hypersensitivity or allergy to eggs, chicken proteins, squalene-based adjuvants, or any other component of the investigational product.
- History of serious adverse reaction or anaphylaxis to any previous influenza vaccine (licensed or not).
- Having received any influenza A/H5 vaccine or history of exposure to avian influenza A/H5.
- Presence of a bleeding disorder or any condition that contraindicates intramuscular injection.
- Having received immunoglobulin, blood, or any blood-derived product in the 3 months prior to the date of the first study vaccination or having had...
See the full eligibility criteria
- Males and non-pregnant females aged ≥ 18 years at the time of the first study vaccination.
- Be in good health and clinically stable (defined as having no pre-existing health condition or having a pre-existing health condition that has not required a change in treatment or hospitalization for worsening of...
- Agree to participate in the study and provide written informed consent prior to the initiation of any study procedures.
- Be able and willing to comply with all study procedures, including completing Participant Diaries, collecting blood samples, and being available for scheduled study visits and contacts.
- For females of childbearing potential, have a negative pregnancy test prior to the first study vaccination.
- For women of childbearing potential, be willing to use effective contraceptive measures during the screening visit until at least 30 days after the second study vaccination.
- Having received any vaccine (including seasonal influenza) 28 days prior to the date of the first study vaccination or having any vaccination in the period from the first vaccination to the immune response assessment...
- Known hypersensitivity or allergy to eggs, chicken proteins, squalene-based adjuvants, or any other component of the investigational product.
- History of serious adverse reaction or anaphylaxis to any previous influenza vaccine (licensed or not).
- Having received any influenza A/H5 vaccine or history of exposure to avian influenza A/H5.
- Presence of a bleeding disorder or any condition that contraindicates intramuscular injection.
- Having received immunoglobulin, blood, or any blood-derived product in the 3 months prior to the date of the first study vaccination or having had immunoglobulin or blood-derived product administered during the entire...
- Having received a solid organ, bone marrow, or stem cell transplant.
- Having a history of asplenia (anatomic or functional).
- Having any confirmed or suspected immunosuppressive or immunodeficiency condition, including a history of human immunodeficiency virus (HIV) infection.
- Having a history of Guillain-Barré syndrome or other demyelinating disease.
- Having a history of neurological disease, seizures, or progressive or severe neurological disorder.
- History of malignant neoplasm or previous history of malignant neoplasm being disease-free for 5 years at the date of the first study vaccination (with the exception of basal cell carcinoma of the skin), autoimmune...
- History of significant, progressive or decompensated chronic disease in the 3 months prior to the date of the first study vaccination (complicated type 2 diabetes mellitus, liver disease, kidney disease, heart disease...
- Having received or using radiotherapy, chemotherapy, cytotoxic drugs, immunosuppressants or immunomodulators in the 6 months prior to the date of the first study vaccination.
- Use of systemic corticosteroids (oral or parenteral) in the 3 months prior to the date of the first study vaccination, at an immunosuppressive dose equivalent to a dose of ≥ 20 mg of prednisone per day for ≥ 14 days or...
- Presenting a behavioral, cognitive disorder/disorder or psychiatric illness that, in the opinion of the Investigator, may interfere with the ability to participate in the study.
- Infection with the human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Abuse of alcohol or drugs in the 12 months prior to the date of the first study vaccination, that may interfere with the ability to participate in the study.
- Body mass index (BMI) ≥ 35 kg/m2 on the date of the first study vaccination.
- Clinically significant abnormalities in the general physical examination.
- Major surgery or surgery with the use of general anaesthesia planned to occur in the period from the first vaccination to the visit to assess the immune response after the last vaccination.
- Women who are pregnant, breastfeeding or planning to become pregnant during the 30 days after the last vaccination in the study.
- Laboratory parameter values at the screening visit equal to or greater than grade 2 will be considered as a criterion for exclusion from participation in the study.
- Presenting any clinically significant condition or situation that, in the opinion of the Investigator, represents a risk to the participant health or may interfere with the evaluation of the study objectives, the...
- Having participated in another clinical trial involving an experimental product, with less than three months between the completion of that follow-up and the planned date of the first vaccination in this study, or plans...
- Institutionalized individual (people residing in long-term care, assistance or health care institutions and deprived of liberty). aa. Being related to or part of the research centre staff or employee directly involved...
The study team makes the final eligibility decision.
Where it's taking place
- Belo Horizonte, Minas Gerais, Brazil
- Recife, Pernambuco, Brazil
- São José do Rio Preto, São Paulo, Brazil
- Serrana, São Paulo, Brazil
- São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belo Horizonte, Minas Gerais, Brazil; Recife, Pernambuco, Brazil; São José do Rio Preto, São Paulo, Brazil; Serrana, São Paulo, Brazil; São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.