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

October 23, 2025 updated by: ILiAD Biotechnologies

Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multi-center, randomized, placebo- and active-comparator-controlled study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease. Healthy school-age children will be randomly assigned to 1 of 3 different study treatment groups to receive the intranasal BPZE1 vaccine, the intramuscular Boostrix vaccine, or both. Subjects will first receive the intranasal vaccine (BPZE1 or placebo) using a small, cone-shaped device that attaches to a syringe and sprays the vaccine into the nose. After a 10-minute waiting period, subjects will receive the intramuscular vaccine (Boostrix or placebo) in the upper arm. As this is the first study in school-age children, a staggered enrollment is planned with the first 45 subjects in the older age group of 11-17 years designated as the safety lead-in cohort. After reactogenicity results from the first 7 days after vaccination of the safety lead-in cohort are reviewed by the safety monitoring committee, the remainder of the subjects will be enrolled. Subjects who choose to take part in a small sub-study of revaccination/attenuated challenge will receive BPZE1 intranasal vaccine (open-label) 3 months after the first vaccination. Safety will be monitored for 6 months after the first vaccination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
368

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia
        • Sydney Children's Hospital
      • Westmead, New South Wales, Australia
        • Sydney Children's Hospital
    • South Australia
      • North Adelaide, South Australia, Australia
        • Women's and Children's Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • University of Melbourne
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Telethon Kids Institute
  • Costa Rica
      • San José, Costa Rica
        • CSA Clinica San Augustin
      • San José, Costa Rica
        • IICIMED Instituto de Investigacion en Ciencias Medicas
      • San José, Costa Rica
        • MRI, Metropolitan Research Institute
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Children's Hospital NHS Foundation Trust
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Bristol, United Kingdom
        • Bristol Royal Hospital for Children
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Leicester, United Kingdom
        • Leicester Children's Hospital, Ward 14, Level 4,
      • London, United Kingdom
        • St George's Healthcare NHS Trust
      • Oxford, United Kingdom
        • Oxford Vaccine Group
      • Southampton, United Kingdom
        • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  1. Male or female subject 6 to 17 years of age on Day 1.
  2. Subject must provide informed consent (assent, depending on age) prior to participation in study and comply with protocol requirements.
  3. 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.
  4. Subject has a stable health status, as established by physical examination, vital sign measurements, and medical history.
  5. 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.
  6. Subject is willing to refrain from routine nasal sprays (including steroid sprays) or washes for at least 7 days following any study vaccination.

Key Exclusion Criteria:

  1. 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.
  2. Chronic significant illness actively being treated or a history of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
  3. History of cancer (malignancy).
  4. Congenital, hereditary, or acquired disease or disorder classified as autoimmune, immunodeficient, coagulopathy, hepatic, renal, neurologic, or cognitive.
  5. 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.
  6. 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.
  7. 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.
  8. History of oro/nasopharynx surgery (eg, adenoidectomy, tonsillectomy) within 60 days prior to Day 1.
  9. 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.
  10. Subject has routine and/or repeated contact with, or is currently living in a household with, an immunocompromised individual.
  11. Subject resides in a residence where an infant less than 6 months of age resides or may reside.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BPZE1 intranasal and Placebo intramuscular
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
Live attenuated pertussis vaccine and placebo
Experimental: BPZE1 intranasal and Boostrix intramuscular
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
Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine
Active Comparator: Placebo intranasal and Boostrix intramuscular
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
Tetanus, diphtheria, and aP vaccine and placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29
Time Frame: 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)
Time Frame: Through 7 days following first study vaccination.
Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events)
Through 7 days following first study vaccination.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus
Time Frame: Day 29
Serum IgG levels against diphtheria, tetanus by treatment groups (BPZE1 + Boostrix vs Boostrix)
Day 29
Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens
Time Frame: Day 29
Serum IgG levels against acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) by treatment groups (BPZE1 + Boostrix vs Boostrix)
Day 29
Mucosal Immunogenicity S-IgA GMR
Time Frame: Baseline, Day 29
Induction of normalized S-IgA against WCE, PT, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development (fimbriae serotype 2 and 3; FIM 2/3) using GMR
Baseline, Day 29
Mucosal Immunogenicity S-IgA GMFR
Time Frame: Day 29
Induction of normalized S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development (FIM 2/3) using GMFR
Day 29
Serum Immunogenicity IgA and IgG GMC
Time Frame: Baseline, Day 29
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development (FIM 2/3) using GMC
Baseline, Day 29
Serum Immunogenicity IgA and IgG GMFR
Time Frame: Baseline, Day 29
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development (FIM 2/3) using GMFR
Baseline, Day 29
Safety: Reactogenicity and AEs
Time Frame: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination respectively
To describe reactogenicity events during the 7 days following any study vaccination (7 days after Day 1 study vaccination and 7 days after Day 85 attenuated challenge with open-label BPZE1), all AEs through 28 days following Day 1 study vaccination and Day 85 attenuated challenge with open-label BPZE1, medically-attended AEs (MAAE) through 84 days following Day 1 study vaccination and Day 85 attenuated challenge with open-label BPZE1, AEs of special interest (AESIs) and serious adverse events (SAE) through Day 169 (EOS).
Through 7 days, 28 days, and 169 days (EOS) following any study vaccination respectively
Colonization (Substudy Only)
Time Frame: Day 92 or Day 99.
Proportion of subjects with positive B. pertussis by culture or polymerase chain reaction [PCR]) following re-vaccination/attenuated challenge (BPZE1, BPZE1 + Boostrix, BPZE1 and BPZE1 + Boostrix, Boostrix control)
Day 92 or Day 99.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ILiAD Biotechnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IB-201P

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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