> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/immunogenicity-and-safety-of-bpze1-intranasal-pertussis-97009868-a889-40f1-a412-79cfd58fed5a > Record changed: 2026-10-13 # Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children NCT05116241 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) Participants 368 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) Lead sponsor ILiAD Biotechnologies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) Start date 2021-11-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) Number of sites 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Short title** Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Official title** 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™) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Dates **Completion date** 2024-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **First posted** 2021-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Registry last updated** 2025-11-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Primary completion date** 2024-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Start date** 2021-11-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Size and sites **Actual participants** 368 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Participants** 368 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Number of sites** 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Lead sponsor** ILiAD Biotechnologies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Identifiers **Registry ID** NCT05116241 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **ClinicalTrials.gov ID** NCT05116241 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Outcomes ### Primary outcomes 1. Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29 Timeframe: 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. 2. Safety: Solicited Adverse Events (AEs) Timeframe: Through 7 days following first study vaccination. Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events) ### Secondary outcomes 1. Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus Timeframe: Day 29 Serum IgG levels against diphtheria, tetanus by treatment groups (BPZE1 + Boostrix vs Boostrix) 2. Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens Timeframe: Day 29 Serum IgG levels against acellular pertussis antigens (pertussis toxin \\\[PT\\\], filamentous hemagglutinin \\\[FHA\\\], pertactin \\\[PRN\\\]) by treatment groups (BPZE1 + Boostrix vs Boostrix) 3. Mucosal Immunogenicity S-IgA GMR Timeframe: 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 4. Mucosal Immunogenicity S-IgA GMFR Timeframe: 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 5. Serum Immunogenicity IgA and IgG GMC Timeframe: 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 6. Serum Immunogenicity IgA and IgG GMFR Timeframe: 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 7. Safety: Reactogenicity and AEs Timeframe: 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). 8. Colonization (Substudy Only) Timeframe: 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Years **Maximum age** 17 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Sites - Sydney Children's HospitalRandwick, Australia - Sydney Children's HospitalWestmead, Australia - Women's and Children's HospitalNorth Adelaide, Australia - University of MelbourneMelbourne, Australia - Telethon Kids InstituteNedlands, Australia - CSA Clinica San AugustinSan José, Costa Rica - IICIMED Instituto de Investigacion en Ciencias MedicasSan José, Costa Rica - MRI, Metropolitan Research InstituteSan José, Costa Rica - Birmingham Children's Hospital NHS Foundation TrustBirmingham, United Kingdom - Bradford Royal InfirmaryBradford, United Kingdom - Bristol Royal Hospital For ChildrenBristol, United Kingdom - Addenbrooke's HospitalCambridge, United Kingdom - Leicester Children's Hospital, Ward 14, Level 4,Leicester, United Kingdom - St George's Healthcare NHS TrustLondon, United Kingdom - Oxford Vaccine GroupOxford, United Kingdom - University Hospital Southampton NHS Foundation TrustSouthampton, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05116241) ## Related records ### Drugs (1) - [Pertussis vaccine](https://trialight.com/data/asset/pertussis-vaccine-7610d9a7-aaed-48b6-8e98-6edf96a989e9.md) ### Lead sponsors (1) - [ILiAD Biotechnologies](https://trialight.com/data/company/iliad-biotechnologies-109fd89f-f83f-432a-9fab-367adccb4cc1.md) ### Conditions (1) - [Pertussis](https://trialight.com/data/condition/pertussis-810232d3-8d41-590a-8f38-1061f23d3a9f.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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