New nasal vaccine could stop whooping cough in its tracks

NCT ID NCT05116241

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

368 people

The number who actually took part.

Started

Nov 2021

Finished

May 2024

Lead sponsor

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

6 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Addenbrooke's Hospital

    Cambridge, 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

  • CSA Clinica San Augustin

    San José, Costa Rica

  • IICIMED Instituto de Investigacion en Ciencias Medicas

    San José, Costa Rica

  • Leicester Children's Hospital, Ward 14, Level 4,

    Leicester, United Kingdom

  • MRI, Metropolitan Research Institute

    San José, Costa Rica

  • Oxford Vaccine Group

    Oxford, United Kingdom

  • St George's Healthcare NHS Trust

    London, United Kingdom

  • Sydney Children's Hospital

    Randwick, New South Wales, Australia

  • Sydney Children's Hospital

    Westmead, New South Wales, Australia

  • Telethon Kids Institute

    Nedlands, Western Australia, Australia

  • University Hospital Southampton NHS Foundation Trust

    Southampton, United Kingdom

  • University of Melbourne

    Melbourne, Victoria, Australia

  • Women's and Children's Hospital

    North Adelaide, South Australia, Australia

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