New nasal vaccine could stop whooping cough in its tracks
NCT ID NCT05116241
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new whooping cough vaccine called BPZE1, given as a nasal spray, in healthy children aged 6 to 17. The goal was to see if it is safe and helps the body fight off whooping cough, either alone or with the standard shot vaccine Boostrix. About 368 children took part, and the study compared the nasal vaccine to a placebo and to the standard shot.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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368 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Addenbrooke's Hospital
Cambridge, United Kingdom
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Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom
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Bradford Royal Infirmary
Bradford, United Kingdom
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Bristol Royal Hospital For Children
Bristol, United Kingdom
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CSA Clinica San Augustin
San José, Costa Rica
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IICIMED Instituto de Investigacion en Ciencias Medicas
San José, Costa Rica
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Leicester Children's Hospital, Ward 14, Level 4,
Leicester, United Kingdom
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MRI, Metropolitan Research Institute
San José, Costa Rica
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Oxford Vaccine Group
Oxford, United Kingdom
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St George's Healthcare NHS Trust
London, United Kingdom
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Sydney Children's Hospital
Randwick, New South Wales, Australia
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Sydney Children's Hospital
Westmead, New South Wales, Australia
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Telethon Kids Institute
Nedlands, Western Australia, Australia
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University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
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University of Melbourne
Melbourne, Victoria, Australia
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Women's and Children's Hospital
North Adelaide, South Australia, Australia
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Other studies related to the condition(s) this trial covers.