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Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine

Phase Ib (High Dose), Single Centre, Dose-escalating, Placebo-controlled, Randomized Study of a Live Attenuated B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Volunteers

NCT02453048•Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

Summary

This study evaluates the safety and immunogenicity of a higher dose formulation of a new live attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal colonization and pertussis disease, and investigates whether higher doses of BPZE1 induce the live vaccine to colonize subjects' nasopharynx. The study is a Phase Ib (high dose), single centre, dose-escalating, placebo-controlled study of the live attenuated B. pertussis strain BPZE1 given as a single intranasal dose to healthy adult volunteer.

Eligibility

Age

18 - 32 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy individual between 18 and 32 years of age, vaccinated or unvaccinated with acellular pertussis vaccine.
•2. Female subject of child bearing potential must be willing to ensure that they use a highly efficient method of contraception during the study (e.g. contraceptive pill, intrauterine contraceptive device).
•3. Informed consent form (ICF) signed by the subject.
•4. Subject shall be able to attend all scheduled visits and to understand and comply with the study procedures.

Exclusion Criteria

•1. Individual with PT and/or PRN serum IgG antibodies ≥20 International units/ml (IU/ml). NOTE! One control group with PRN serum IgG antibodies ≥ 20 IU/ml will be included.
•2. Vaccinated with the study vaccine in the Child Innovac study (EudraCT number 2010-019936-11).
•3. Pregnant or lactating women. Pregnancy not planned and to be avoided during the study by use of effective contraceptive methods.
•4. Blood pressure after resting ≥ 150/90 mm Hg at screening.
•5. Heart rate after resting ≥ 80 bpm at screening.
•6. Respiratory rate after resting ≥ 20/minute at screening.
•7. Unwillingness to refrain from the use of nicotine products from screening through day 28.
•8. Use of narcotic drugs and/or a history of drug/alcohol abuse with in the past 2 years prior to screening
•9. The subject has donated blood or suffered from blood loss of at least 450 ml (1 unit of blood) within 60 days prior to screening or donated plasma within 14 days prior to screening.
•10. Receipt of immunoglobulin, blood derived products, systemic corticosteroids or other immunosuppressant drugs within 90 days prior to day 0.
+13 more criteria

Locations (1)

Karolinska University Hospital

Huddinge, Stockholm County, Sweden

Key Dates

Start Date

September 1, 2015

Primary Completion Date

March 1, 2017

Completion Date

December 1, 2017

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

PertussisWhooping Cough

Interventions

BPZE1

BIOLOGICAL

Placebo

OTHER

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine

Inclusion Criteria

Exclusion Criteria

Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

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Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy

A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)