- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05116241
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
November 30, 2023 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
Active, not recruiting
Conditions
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
Interventional
Enrollment (Estimated)
360
Phase
- 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
- Name: ILiAD Biotechnologies
- Phone Number: (954) 907-6471
- Email: ClinicalTrials@iliadbiotech.com
Study Locations
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New South Wales
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Randwick, New South Wales, Australia
- Sydney Children's Hospital
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Westmead, New South Wales, Australia
- Sydney Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia
- Women's and Children's Hospital
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Victoria
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Melbourne, Victoria, Australia
- University of Melbourne
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Western Australia
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Nedlands, Western Australia, Australia
- Telethon Kids Institute
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San José, Costa Rica
- CSA Clinica San Augustin
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San José, Costa Rica
- IICIMED Instituto de Investigacion en Ciencias Medicas
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San José, Costa Rica
- MRI, Metropolitan Research Institute
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Birmingham, United Kingdom
- Birmingham Children's Hospital NHS Foundation Trust
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Bradford, United Kingdom
- Bradford Royal Infirmary
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Bristol, United Kingdom
- Bristol Royal Hospital for Children
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Cambridge, United Kingdom
- Addenbrooke's Hospital
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Leicester, United Kingdom
- Leicester Children's Hospital, Ward 14, Level 4,
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London, United Kingdom
- St George's Healthcare NHS Trust
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Oxford, United Kingdom
- Oxford Vaccine Group
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Southampton, United Kingdom
- University Hospital Southampton NHS Foundation Trust
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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
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- History of pertussis-containing vaccination or documented pertussis infection within 3 years prior to Day 1 and/or a history of Td-containing vaccination (without pertussis 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.
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 |
Intervention / Treatment |
---|---|
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.
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Live attenuated pertussis vaccine and placebo
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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).
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Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine
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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).
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Tetanus, diphtheria, and aP vaccine and placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA
Time Frame: Day 29
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Geometric mean titer (GMT) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).
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Day 29
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Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA
Time Frame: Day 29
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Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).
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Day 29
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Immunogenicity Serum IgG: proportion of subjects with antibody concentration ≥0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens
Time Frame: Day 29
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Serum IgG levels against diphtheria, tetanus and acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) by treatment groups (BPZE1 + Boostrix vs Boostrix)
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Day 29
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Colonization (substudy only)
Time Frame: Day 92 or Day 99.
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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)
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Day 92 or Day 99.
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Safety: Solicited Adverse Events (AEs)
Time Frame: Through 7 days following first study vaccination.
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Solicited AEs (local, nasal/respiratory, and systemic reactogenicity events)
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Through 7 days following first study vaccination.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mucosal Immunogenicity S-IgA
Time Frame: Day 29, Day 85, Day 169 (EOS).
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Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMT
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Day 29, Day 85, Day 169 (EOS).
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Mucosal Immunogenicity S-IgA
Time Frame: Day 29, Day 85, Day 169 (EOS).
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Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMFR
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Day 29, Day 85, Day 169 (EOS).
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Serum Immunogenicity S-IgA and IgG
Time Frame: Baseline, Day 29, Day 85, Day 169 (EOS).
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Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development using GMT
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Baseline, Day 29, Day 85, Day 169 (EOS).
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Serum Immunogenicity S-IgA and IgG
Time Frame: Baseline, Day 29, Day 85, Day 169 (EOS).
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Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development using GMFR
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Baseline, Day 29, Day 85, Day 169 (EOS).
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Safety: Reactogenicity and AEs
Time Frame: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination.
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To describe reactogenicity events during the 7 days following any study vaccination, all AEs through 28 days following study vaccination, medically-attended AEs through 84 days following study vaccination, AEs of special interest (AESIs) and serious adverse events (SAE) through Day 169 (EOS), and incidence of severe acute respiratory syndrome-corona virus-2 (SARS-CoV-2) infections or AESIs.
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Through 7 days, 28 days, and 169 days (EOS) following any study vaccination.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 28, 2021
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
October 20, 2021
First Submitted That Met QC Criteria
November 2, 2021
First Posted (Actual)
November 10, 2021
Study Record Updates
Last Update Posted (Actual)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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