Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

NCT05116241 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IB-201P
• Study Type: interventional
• Target: 368
• Locations: 3 countries
• Sites: 16

Brief Summary

This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.

Conditions

Bordetella Pertussis, Whooping Cough

Keywords

Bordetella pertussis (B. pertussis); Whooping Cough; BPZE1; Boostrix; Vaccine; Children; Booster; Live attenuated vaccine

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29

  Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix) at Day 29.

  Day 29

• Safety: Solicited Adverse Events (AEs)

  Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events)

  Through 7 days following first study vaccination.

Secondary Outcomes (8)

• Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus

  Day 29

• Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens

  Day 29

• Mucosal Immunogenicity S-IgA GMR

  Baseline, Day 29

• Mucosal Immunogenicity S-IgA GMFR

  Day 29

• Serum Immunogenicity IgA and IgG GMC

  Baseline, Day 29

Study Arms (3)

BPZE1 intranasal and Placebo intramuscular

EXPERIMENTAL

Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.

Biological: BPZE1 pertussis vaccine and placebo

BPZE1 intranasal and Boostrix intramuscular

EXPERIMENTAL

Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis \[aP\] vaccine).

Biological: BPZE1 pertussis vaccine and Boostrix

Placebo intranasal and Boostrix intramuscular

ACTIVE COMPARATOR

Individual will receive an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).

Biological: Placebo and Boostrix

Interventions

BPZE1 pertussis vaccine and placebo BIOLOGICAL

Live attenuated pertussis vaccine and placebo

BPZE1 intranasal and Placebo intramuscular

BPZE1 pertussis vaccine and Boostrix BIOLOGICAL

Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine

BPZE1 intranasal and Boostrix intramuscular

Placebo and Boostrix BIOLOGICAL

Tetanus, diphtheria, and aP vaccine and placebo

Placebo intranasal and Boostrix intramuscular

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subject 6 to 17 years of age on Day 1.
• Subject must provide informed consent (assent, depending on age) prior to participation in study and comply with protocol requirements.
• If female, the subject is not pregnant or lactating. If female of childbearing potential, the subject must agree to either be heterosexually inactive or follow birth control methods per protocol from at least 21 days prior to enrollment and through 90 days following any study vaccination.
• Subject has a stable health status, as established by physical examination, vital sign measurements, and medical history.
• Subject (and/or legal guardian) has access to a consistent and reliable means of electronic or telephone contact, which may be in the home, workplace, school, or by personal mobile electronic device.
• Subject is willing to refrain from routine nasal sprays (including steroid sprays) or washes for at least 7 days following any study vaccination.

You may not qualify if:

• The subject has a history of whole-cell pertussis vaccination in lifetime, acellular pertussis-containing vaccination (inclusive of school vaccination programs) within 3 years prior to Day 1, documented B. pertussis infection within 3 years prior to Day 1, or a history of Td-containing vaccination (without pertussis vaccine component) within 1 month prior to Day 1.
• Chronic significant illness actively being treated or a history of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
• History of cancer (malignancy).
• Congenital, hereditary, or acquired disease or disorder classified as autoimmune, immunodeficient, coagulopathy, hepatic, renal, neurologic, or cognitive.
• Currently uses smoking products (including vaping and e-cigarettes) and is unwilling to refrain from use from Day 1 through Day 29 following study vaccination.
• Subject received immunoglobulin, blood-derived products, systemic corticosteroids (at a dose of \>10 mg per day for more than 10 days), or other immunosuppressant drugs within 90 days of Day 1.
• Chronic pulmonary disease requiring active medication or pulmonary therapies except exercise-induced bronchospasm, if currently well controlled, and willing to refrain from intense exercise for 7 days following study vaccination, or intermittent asthma classification who have not had an exacerbation requiring oral systemic corticosteroids in the past year; have an forced expiratory volume (FEV1) documented to be \>80%; do not have restrictions in normal activity due to breathing issues; and have used a short-acting beta-agonist less than or equal to 2 days per week over the past 2 months.
• History of oro/nasopharynx surgery (eg, adenoidectomy, tonsillectomy) within 60 days prior to Day 1.
• Known hypersensitivity to latex or any component of any study vaccine. Specific to Boostrix: hypersensitivity to neomycin or polymyxin; hypersensitivity after previous administration of diphtheria, tetanus, or pertussis vaccines; or has experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus.
• Subject has routine and/or repeated contact with, or is currently living in a household with, an immunocompromised individual.
• Subject resides in a residence where an infant less than 6 months of age resides or may reside.

Sponsors & Collaborators

• ILiAD Biotechnologies: lead

Study Sites (16)

Sydney Children's Hospital

Randwick, New South Wales, Australia

Location

Sydney Children's Hospital

Westmead, New South Wales, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Location

University of Melbourne

Melbourne, Victoria, Australia

Location

Telethon Kids Institute

Nedlands, Western Australia, Australia

Location

CSA Clinica San Augustin

San José, Costa Rica

Location

IICIMED Instituto de Investigacion en Ciencias Medicas

San José, Costa Rica

Location

MRI, Metropolitan Research Institute

San José, Costa Rica

Location

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, United Kingdom

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Bristol Royal Hospital For Children

Bristol, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Leicester Children's Hospital, Ward 14, Level 4,

Leicester, United Kingdom

Location

St George's Healthcare NHS Trust

London, United Kingdom

Location

Oxford Vaccine Group

Oxford, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Whooping Cough

Interventions

Boostrix

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: ILiAD Biotechnologies

contact@iliadbiotech.com

800-603-3525

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: November 11, 2021
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

CO (3); GB (8); AU (5)