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

NCT06842173 | Recruiting Phase 1 DMC

• 1 other identifier: FLP-02-IB
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Avian Influenza A Virus

Keywords

Influenza A Virus Subtype H5N8; Avian Influenza; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  21 days post second vaccination

Secondary Outcomes (19)

• Safety - Percentage of participants with unsolicited adverse events

  21 days post each vaccination

• Safety - Percentage and intensity of unsolicited adverse events

  21 days post each vaccination

• Safety - Percentage of participants with unsolicited adverse reactions

  21 days post each vaccination

• Safety - Percentage and intensity of unsolicited adverse reactions

  21 days post second vaccination

• Percentage of participants with adverse events of special interest (AEI)

  the entire follow-up of the study (6 months)

Study Arms (3)

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).

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).

Biological: Monovalent influenza vaccine type A (H5N8) 15 mcg

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Monovalent influenza vaccine type A (H5N8) 15 mcg BIOLOGICAL

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

Also known as: Avian Flu vaccine

Monovalent influenza vaccine A (H5N8) 15 mcg

Placebo OTHER

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

Also known as: Control arm

Placebo

Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg BIOLOGICAL

Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total)

Also known as: Avian Flu vaccine

Monovalent Influenza Vaccine A (H5N8) 7.5 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.
• 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.

Sponsors & Collaborators

• Butantan Institute: lead
• Butantan Foundation: collaborator

Study Sites (5)

Centro de Terapias Avançadas E Inovadoras - Ct Terapias/Ufmg

Belo Horizonte, Minas Gerais, 30750-140, Brazil

NOT YET RECRUITING

Plátano Centro de Pesquisa Clínica LTDA

Recife, Pernambuco, 52011-040, Brazil

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, Brazil

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, Brazil

NOT YET RECRUITING

Centro de Pesquisas Clínicas do Hospital das Clínicas da FMUSP

São Paulo, 05403-010, Brazil

NOT YET RECRUITING

Related Publications (4)

• 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.

  PMID: 32492039 BACKGROUND

• Francis 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.

  PMID: 25110294 BACKGROUND

• Miyaki 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.

  PMID: 21684420 BACKGROUND

• Vanni 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.

  PMID: 36256646 BACKGROUND

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Double-blind clinical trial. Randomization, preparation and masking of the Product Under Investigation by an unblinded professional at the research site.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 24, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)