Avian Influenza A VirusPhase 1/2NCT06842173
Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults
A Phase 1/2 study testing Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg and Monovalent influenza vaccine type A (H5N8) 15 mcg in people with Avian Influenza A Virus, run by Butantan Institute at 5 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Avian Influenza A Virus
- What is being tested?
- Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg and Monovalent influenza vaccine type A (H5N8) 15 mcg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 5 sitesBrazil
- Study dates
- 10 Sep 2025to 10 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 disease in the 3 months prior to the date of the first study vaccination).
- 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.
Who cannot join
- 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 visit after the last vaccination.
- 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 follow-up of the study.
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- 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 disease (including type 1 diabetes mellitus), liver cirrhosis and renal failure.
- 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, advanced arteriosclerotic disease or lung disease such as oxygen-dependent chronic obstructive pulmonary disease, among others).
- 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 a cumulative dose of ≥ 280 mg. Topical use of corticosteroids (e.g., cream, eye drops, inhalation and intranasal sprays) is permitted, within the dosage indicated on the product label.
- 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 schedule of visits, participation in or completion of the study (such as planned travel or change of residence, among others).
- 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 to enter a clinical study during the period of this study.
- 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 in the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Not yet recruiting
Centro de Terapias Avançadas E Inovadoras - Ct Terapias/Ufmg
Belo Horizonte, Minas Gerais, 30750-140
Mauro MD Teixeira, PhD, (31)2520-4008, mmtex.ufmg@gmail.com
- Recruiting
Plátano Centro de Pesquisa Clínica LTDA
Recife, Pernambuco, 52011-040
Carlos MD Brito, PhD, (81)99127-7732, cbritoc@gmail.com
- Not yet recruiting
Fundação Faculdade Regional de Medicina de São Jose do Rio Preto - (Centro integrado de Pesquisa CIP)
São José do Rio Preto, São Paulo, 15090-000
Mauricio MD Nogueira, PhD, (17)98811-0550, mauricio.nogueira@edu.famerp.br
- Not yet recruiting
Centro de Pesquisas Clínicas do Hospital das Clínicas da FMUSP
São Paulo, 05403-010
Ferdinando MD Menezes, PhD, (11)98373-2290, f.menezes@hc.fm.usp.br
- Not yet recruiting
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
Marcos MD Borges, PhD, (16)98116-5608, marcosborges@fmrp.usp.br
About this study
Official title: 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
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.
Read the 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
- Being tested
- Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg, Monovalent influenza vaccine type A (H5N8) 15 mcg, Placebo
- Keywords
- Influenza A Virus Subtype H5N8, Avian Influenza, Safety, Immunogenicity
- Medical subject headings
- Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcgBiological
Also called Avian Flu vaccine
Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total)
Monovalent influenza vaccine type A (H5N8) 15 mcgBiological
Also called Avian Flu vaccine
Monovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total)
PlaceboOther
Also called Control arm
Phosphate buffered saline (PBS) (0.5 mL/dose).
| Study group | Role | What they receive |
|---|---|---|
| Monovalent Influenza Vaccine A (H5N8) 7.5 mcg | Experimental | Intervention: Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) from Instituto Butantan, containing 7.5 mcg/dose of hemagglutinin (HA) and adjuvant IB160 (0.5 mL/dose of final combined product). Receives: Biological: Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg |
| Monovalent influenza vaccine A (H5N8) 15 mcg | Experimental | Intervention: Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) from Instituto Butantan, containing 15 mcg/dose of hemagglutinin (HA) and adjuvant IB160 (0.5 mL/dose of final combined product). Receives: Biological: Monovalent influenza vaccine type A (H5N8) 15 mcg |
| Placebo | Placebo comparator | Phosphate buffered saline (PBS) (0.5 mL/dose). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Percentage of participants with solicited and unsolicited adverse events
Percentage (%) of participants with solicited (local and systemic) and unsolicited adverse events, for each intervention group, in adults and older adults.
Measured: 7 days post each vaccination.
Safety - Percentage of solicited and unsolicited adverse events by intensity degree
Percentage of solicited and unsolicited adverse events by intensity degree for each intervention group, in adults and older adults.
Measured: 7 days post each vaccination
Safety - Percentage of participants with solicited and unsolicited adverse reactions
Percentage of participants with solicited and unsolicited adverse reactions, for each intervention group, in adults and older adults.
Measured: 7 days post each vaccination
Safety - Percentage of solicited and unsolicited adverse reactions by intensity degree
Percentage of solicited and unsolicited adverse reactions by intensity degree for each intervention group, in adults and older adults.
Measured: 7 days post each vaccination
Safety - Description of solicited adverse reactions, regarding duration, time until onset and use of medication
Description of solicited adverse reactions, regarding duration, time until onset and use of medication, for each intervention group, in adults and older adults.
Measured: 7 days post each vaccination
Immunogenicity - Seroconversion rate post second vaccination
Seroconversion rate after the second vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: 21 days post second vaccination
Immunogenicity - Seroprotection rate post second vaccination
Seroprotection rate after the second vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: 21 days post second vaccination
Secondary outcomes (19)
Safety - Percentage of participants with unsolicited adverse events
Percentage of participants with unsolicited adverse events, for each intervention group, in adults and older adults.
Measured: 21 days post each vaccination
Safety - Percentage and intensity of unsolicited adverse events
Percentage and intensity of unsolicited adverse events, for each intervention group, in adults and older adults.
Measured: 21 days post each vaccination
Safety - Percentage of participants with unsolicited adverse reactions
Percentage of participants with unsolicited adverse reactions, for each intervention group, in adults and older adults.
Measured: 21 days post each vaccination
Safety - Percentage and intensity of unsolicited adverse reactions
Percentage and intensity of unsolicited adverse reactions,, for each intervention group, in adults and older adults.
Measured: 21 days post second vaccination
Percentage of participants with adverse events of special interest (AEI)
Percentage of participants with adverse events of special interest (AEI), for each intervention group, in adults and older adults.
Measured: the entire follow-up of the study (6 months)
Safety - Percentage and intensity of the participants with adverse events of special interest (AEI)
Percentage and intensity of the participants with adverse events of special interest (AEI), for each intervention group, in adults and older adults.
Measured: The entire follow-up of the study (6 months)
Safety - Percentage of participants with serious adverse events (SAE)
Percentage of participants with serious adverse events (SAE), for each intervention group, in adults and older adults.
Measured: Entire follow-up of the study (6 months)
Safety - Percentage and intensity of serious adverse events (SAE)
Percentage and intensity of serious adverse events (SAE), for each intervention group, in adults and older adults.
Measured: entire follow-up of the study (6 months)
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Ratio between the Geometric Mean Titers (rGMT) of antibodies compared to that of pre-vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: 21 days post the first vaccination
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Ratio of the Geometric Mean Titers (rGMT) of antibodies, post second vaccination about that of pre-vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: 21 days post the second vaccination
Immunogenicity - Seroconversion rate
Seroconversion rate (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: 21 days post the first vaccination
Immunogenicity - Geometric Mean Titers (GMT)
Geometric Mean Titers (GMT) pre and post-vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: pre-vaccination, 21 days post the first vaccination and 21 days post the second vaccination.
Immunogenicity - Seroprotection rate
Seroprotection rate pre and post-vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Measured: pre-vaccination and 21 days post first vaccination
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Ratio between the Geometric Mean Titers (rGMT) of antibodies, pre and post-vaccination (by microneutralization test - MN), for each intervention group, in adults and older adults.
Measured: 21 days post the first vaccination
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Ratio between the Geometric Mean Titers (rGMT) of antibodies, pre and post-vaccination (by microneutralization test - MN), for each intervention group, in adults and older adults.
Measured: 21 days post the second vaccination
Immunogenicity - Seroconversion rate pre and post vaccination
Seroconversion rate 21 days post the first vaccination and 21 days post the second vaccination (by microneutralization test - MN), for each intervention group, in adults and older adults.
Measured: 21 days post the first vaccination and 21 days post the second vaccination.
Immunogenicity - Seroprotection rate pre and post-vaccination
Seroprotection rate pre-vaccination, 21 days after the first vaccination and 21 days after the second vaccination (by microneutralization test - MN), for each intervention group, in adults and older adults.
Measured: pre-vaccination, 21 days post the first vaccination and 21 days post the second vaccination
Immunogenicity - Geometric Mean Titers (GMT) pre and post-vaccination
Geometric Mean Titers (GMT) pre vaccination, 21 days post the first vaccination and 21 days after the second vaccination (by the microneutralization test - MN), for each intervention group, in adults and older adults.
Measured: pre vaccination, 21 days post the first vaccination and 21 days post the second vaccination.
Immunogenicity - Estimation of rGMT between the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) containing 7.5 mcg of HA/dose compared to that containing 15 mcg of HA/dose
Estimation of rGMT between the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) containing 7.5 mcg of HA/dose compared to that containing 15 mcg of HA/dose (by the hemagglutination inhibition test - HI)
Measured: 21 days post the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start10 Sep 2025
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Avian Influenza A VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind clinical trial. Randomization, preparation and masking of the Product Under Investigation by an unblinded professional at the research site.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Collaborators
- Butantan Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842173
- Sponsor's protocol ID
- FLP-02-IB
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akamatsu MA, Sakihara VA, Carvalho BP, de Paiva Abrantes A, Takano MAS, Adami EA, Yonehara FS, Dos Santos Carneiro P, Rico S, Schanoski A, Meros M, Simpson A, Phan T, Fox CB, Ho PL. Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. PLoS One. 2020 Jun 3;15(6):e0233632. doi: 10.1371/journal.pone.0233632. eCollection 2020.
PubMed 32492039Francis DP, Du YP, Precioso AR. Global vaccine supply. The increasing role of manufacturers from middle income countries. Vaccine. 2014 Sep 15;32(41):5259-65. doi: 10.1016/j.vaccine.2014.07.069. Epub 2014 Aug 8.
PubMed 25110294Miyaki C, Meros M, Precioso AR, Raw I. Influenza vaccine production for Brazil: a classic example of successful North-South bilateral technology transfer. Vaccine. 2011 Jul 1;29 Suppl 1:A12-5. doi: 10.1016/j.vaccine.2011.04.127.
PubMed 21684420Vanni T, Thome BC, Sparrow E, Friede M, Fox CB, Beckmann AM, Huynh C, Mondini G, Silveira DH, Viscondi JYK, Braga PE, Silva AD, Salomao MDG, Piorelli RO, Santos JP, Gattas VL, Lucchesi MBB, Oliveira MMM, Koike ME, Kallas EG, Campos LMA, Coelho EB, Siqueira MAM, Garcia CC, Miranda MD, Paiva TM, Timenetsky MDCST, Adami EA, Akamatsu MA, Ho PL, Precioso AR. Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial. PLoS One. 2022 Oct 18;17(10):e0274943. doi: 10.1371/journal.pone.0274943. eCollection 2022.
PubMed 36256646
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06842173
- Acronym / sponsor ID
- FLP-02-IB
- Conditions
- Avian Influenza A Virus
- Keywords
- Influenza A Virus Subtype H5N8, Avian Influenza, Safety, Immunogenicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Butantan InstituteOther government
- Collaborators
- Butantan Foundation
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind clinical trial. Randomization, preparation and masking of the Product Under Investigation by an unblinded professional at the research site.
| Arm | Type | Receives |
|---|---|---|
| Monovalent Influenza Vaccine A (H5N8) 7.5 mcg | Experimental | Biological: Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcgIntervention: Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) from Instituto Butantan, containing 7.5 mcg/dose of hemagglutinin (HA) and adjuvant IB160 (0.5 mL/dose of final combined product). |
| Monovalent influenza vaccine A (H5N8) 15 mcg | Experimental | Biological: Monovalent influenza vaccine type A (H5N8) 15 mcgIntervention: Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) from Instituto Butantan, containing 15 mcg/dose of hemagglutinin (HA) and adjuvant IB160 (0.5 mL/dose of final combined product). |
| Placebo | Placebo comparator | Other: PlaceboPhosphate buffered saline (PBS) (0.5 mL/dose). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 disease in the 3 months prior to the date of the first study vaccination).
- 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.
Key exclusion criteria (27 listed)
- 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 visit after the last vaccination.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcgAlso: Avian Flu vaccineMonovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total) | Biological | Monovalent Influenza Vaccine A (H5N8) 7.5 mcg |
| Monovalent influenza vaccine type A (H5N8) 15 mcgAlso: Avian Flu vaccineMonovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total) | Biological | Monovalent influenza vaccine A (H5N8) 15 mcg |
| PlaceboAlso: Control armPhosphate buffered saline (PBS) (0.5 mL/dose). | Other | Placebo |
Primary outcome
Safety - Percentage of participants with solicited and unsolicited adverse events
Time frame: 7 days post each vaccination.
Percentage (%) of participants with solicited (local and systemic) and unsolicited adverse events, for each intervention group, in adults and older adults.
Safety - Percentage of solicited and unsolicited adverse events by intensity degree
Time frame: 7 days post each vaccination
Percentage of solicited and unsolicited adverse events by intensity degree for each intervention group, in adults and older adults.
Safety - Percentage of participants with solicited and unsolicited adverse reactions
Time frame: 7 days post each vaccination
Percentage of participants with solicited and unsolicited adverse reactions, for each intervention group, in adults and older adults.
Safety - Percentage of solicited and unsolicited adverse reactions by intensity degree
Time frame: 7 days post each vaccination
Percentage of solicited and unsolicited adverse reactions by intensity degree for each intervention group, in adults and older adults.
Safety - Description of solicited adverse reactions, regarding duration, time until onset and use of medication
Time frame: 7 days post each vaccination
Description of solicited adverse reactions, regarding duration, time until onset and use of medication, for each intervention group, in adults and older adults.
Immunogenicity - Seroconversion rate post second vaccination
Time frame: 21 days post second vaccination
Seroconversion rate after the second vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
Immunogenicity - Seroprotection rate post second vaccination
Time frame: 21 days post second vaccination
Seroprotection rate after the second vaccination (by the hemagglutination inhibition test - HI), for each intervention group, in adults and older adults.
19 secondary outcomes
Safety - Percentage of participants with unsolicited adverse events
Time frame: 21 days post each vaccination
Safety - Percentage and intensity of unsolicited adverse events
Time frame: 21 days post each vaccination
Safety - Percentage of participants with unsolicited adverse reactions
Time frame: 21 days post each vaccination
Safety - Percentage and intensity of unsolicited adverse reactions
Time frame: 21 days post second vaccination
Percentage of participants with adverse events of special interest (AEI)
Time frame: the entire follow-up of the study (6 months)
Safety - Percentage and intensity of the participants with adverse events of special interest (AEI)
Time frame: The entire follow-up of the study (6 months)
Safety - Percentage of participants with serious adverse events (SAE)
Time frame: Entire follow-up of the study (6 months)
Safety - Percentage and intensity of serious adverse events (SAE)
Time frame: entire follow-up of the study (6 months)
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Time frame: 21 days post the first vaccination
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Time frame: 21 days post the second vaccination
Immunogenicity - Seroconversion rate
Time frame: 21 days post the first vaccination
Immunogenicity - Geometric Mean Titers (GMT)
Time frame: pre-vaccination, 21 days post the first vaccination and 21 days post the second vaccination.
Immunogenicity - Seroprotection rate
Time frame: pre-vaccination and 21 days post first vaccination
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Time frame: 21 days post the first vaccination
Immunogenicity - Ratio between the Geometric Mean Titers (rGMT) of antibodies
Time frame: 21 days post the second vaccination
Immunogenicity - Seroconversion rate pre and post vaccination
Time frame: 21 days post the first vaccination and 21 days post the second vaccination.
Immunogenicity - Seroprotection rate pre and post-vaccination
Time frame: pre-vaccination, 21 days post the first vaccination and 21 days post the second vaccination
Immunogenicity - Geometric Mean Titers (GMT) pre and post-vaccination
Time frame: pre vaccination, 21 days post the first vaccination and 21 days post the second vaccination.
Immunogenicity - Estimation of rGMT between the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) containing 7.5 mcg of HA/dose compared to that containing 15 mcg of HA/dose
Time frame: 21 days post the second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 32492039Akamatsu MA, Sakihara VA, Carvalho BP, de Paiva Abrantes A, Takano MAS, Adami EA, Yonehara FS, Dos Santos Carneiro P, Rico S, Schanoski A, Meros M, Simpson A, Phan T, Fox CB, Ho PL. Preparedness against pandemic influenza: Production of an oil-in-water emulsion adjuvant in Brazil. PLoS One. 2020 Jun 3;15(6):e0233632. doi: 10.1371/journal.pone.0233632. eCollection 2020.
- Background: PubMed 25110294Francis DP, Du YP, Precioso AR. Global vaccine supply. The increasing role of manufacturers from middle income countries. Vaccine. 2014 Sep 15;32(41):5259-65. doi: 10.1016/j.vaccine.2014.07.069. Epub 2014 Aug 8.
- Background: PubMed 21684420Miyaki C, Meros M, Precioso AR, Raw I. Influenza vaccine production for Brazil: a classic example of successful North-South bilateral technology transfer. Vaccine. 2011 Jul 1;29 Suppl 1:A12-5. doi: 10.1016/j.vaccine.2011.04.127.
- Background: PubMed 36256646Vanni T, Thome BC, Sparrow E, Friede M, Fox CB, Beckmann AM, Huynh C, Mondini G, Silveira DH, Viscondi JYK, Braga PE, Silva AD, Salomao MDG, Piorelli RO, Santos JP, Gattas VL, Lucchesi MBB, Oliveira MMM, Koike ME, Kallas EG, Campos LMA, Coelho EB, Siqueira MAM, Garcia CC, Miranda MD, Paiva TM, Timenetsky MDCST, Adami EA, Akamatsu MA, Ho PL, Precioso AR. Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial. PLoS One. 2022 Oct 18;17(10):e0274943. doi: 10.1371/journal.pone.0274943. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centro de Terapias Avançadas E Inovadoras - Ct Terapias/Ufmg
Belo Horizonte, Brazil
Fundação Faculdade Regional de Medicina de São Jose do Rio Preto - (Centro integrado de Pesquisa CIP)
São José do Rio Preto, Brazil
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg and Monovalent influenza vaccine type A (H5N8) 15 mcg in people with Avian Influenza A Virus, run by Butantan Institute at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Percentage of participants with solicited and unsolicited adverse events (time frame: 7 days post each vaccination.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06842173, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.