Bordetella Pertussis, Whooping Cough Clinical Trial
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™)
Verified date | November 2023 |
Source | ILiAD Biotechnologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 360 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | 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. 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. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | University of Melbourne | Melbourne | Victoria |
Australia | Telethon Kids Institute | Nedlands | Western Australia |
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | Sydney Children's Hospital | Westmead | New South Wales |
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 | San José | |
United Kingdom | Birmingham Children's Hospital NHS Foundation Trust | Birmingham | |
United Kingdom | Bradford Royal Infirmary | Bradford | |
United Kingdom | Bristol Royal Hospital For Children | Bristol | |
United Kingdom | Addenbrooke's Hospital | Cambridge | |
United Kingdom | Leicester Children's Hospital, Ward 14, Level 4, | Leicester | |
United Kingdom | St George's Healthcare NHS Trust | London | |
United Kingdom | Oxford Vaccine Group | Oxford | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton |
Lead Sponsor | Collaborator |
---|---|
ILiAD Biotechnologies |
Australia, Costa Rica, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA | Geometric mean titer (GMT) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control). | Day 29 | |
Primary | Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA | Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control). | Day 29 | |
Primary | Immunogenicity Serum IgG: proportion of subjects with antibody concentration =0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens | 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) | Day 29 | |
Primary | Colonization (substudy only) | 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. | |
Primary | Safety: Solicited Adverse Events (AEs) | Solicited AEs (local, nasal/respiratory, and systemic reactogenicity events) | Through 7 days following first study vaccination. | |
Secondary | Mucosal Immunogenicity S-IgA | Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMT | Day 29, Day 85, Day 169 (EOS). | |
Secondary | Mucosal Immunogenicity S-IgA | Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMFR | Day 29, Day 85, Day 169 (EOS). | |
Secondary | Serum Immunogenicity S-IgA and IgG | 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 | Baseline, Day 29, Day 85, Day 169 (EOS). | |
Secondary | Serum Immunogenicity S-IgA and IgG | 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 | Baseline, Day 29, Day 85, Day 169 (EOS). | |
Secondary | Safety: Reactogenicity and AEs | 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. | Through 7 days, 28 days, and 169 days (EOS) following any study vaccination. |
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