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PertussisPhase 1NCT01188512

First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine

A Phase 1 study testing BPZE1 in people with Pertussis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers. Read more about this study

Who is it for?
Ages 19 to 31 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pertussis
What is being tested?
BPZE1
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteSweden
Study dates
Aug 2010to Jan 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 31 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject will be included in the study if he meets all the following criteria:
  • Healthy male born between 1979 and 1991 who has not experienced clinical pertussis (lab. Verified) during the past 10 years and who has not been vaccinated with any pertussis vaccine.
  • Informed consent form signed by the subject.
  • Subject shall be able to attend all scheduled visits and to understand and comply with the study procedures (e.g. able to read and write Swedish).

Who cannot join

  • If any of the following criteria are met, the subject must not be included in the study:
  • Individuals with pertussis toxin serum IgG antibodies ≥20 units/mL.
  • Blood pressure after resting ≥ 150/90 mmHg.
  • Heart rate after resting ≥80 bpm.
  • Respiratory rate after resting ≥ 20/minute.
  • Unwillingness to refrain from the use of nicotine products from screening through day 28.
Show all 21Show fewer
  • Use of narcotic drugs/alcohol and/or a history of previous use of drug/alcohol abuse whitin the past 2 years prior to screening
  • 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.
  • Receipt of immunoglobulin, blood derived products, systemic corticosteroids or other immunosuppressant drugs within 90 days prior to day 0.
  • Use of corticosteroids in the respiratory tract(e.g. nasal steroids, inhaled steroids) whitin 30 days prior to day 0.
  • Use of herbal medications or dietary supplements within 7 days prior to day 0 at the discretion of the investigator. Unwillingness to refrain from herbal medications or dietary supplements within 30 days after day 0 at the discretion of the investigator.
  • Receipt of a vaccine within the last 30 days prior to day 0 or planned vaccination within the next 30 days after day 0.
  • Evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine.
  • Known hypersensitivity to any component of the study vaccine.
  • Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0.
  • Inability to adhere to the protocol, including plans to move from the area.
  • Family history of congenital or hereditary immunodeficiency (first degree).
  • Infection with HIV, hepatitis B or C.
  • Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  • Clinically significant abnormal laboratory values at the discretion of the investigator.
  • Person in frequent contact with children less than 1 year of age (father, childcare worker, nurse, etc…) or residence in the same household as persons with known immunodeficiency.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska University Hospital

    Solna, 171 76

Other trials in Sweden

About this study

Official title: A Phase 1, Single Centre, Dose-escalating, Placebo-controlled Study of a Genetically Modified B. Pertussis Strain Given as a Single Intranasal Dose to Healthy Adult Male Volunteers

The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers.

Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most vulnerable age group), preferably after a single administration very early in life. The successful outcome of this project would constitute an important milestone towards nasal vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our ultimate aim is to protect infants in the most vulnerable age group, before the regular vaccination schedule using already available vaccines is applied. The ultimate aim is thus not to replace current vaccination schedules with available vaccines, but to add a first nasal vaccination to protect very early in life.

Conditions
Pertussis
Being tested
BPZE1, Placebo
Keywords
Live nasal vaccine for prevention of pertussis
Medical subject headings
Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPZE1Biological

    Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).

  • PlaceboBiological

    Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).

Study groups in NCT01188512
Study groupRoleWhat they receive
BPZE1 - Low doseExperimental1,000 colony forming units (cfu) of BPZE1
Receives: Biological: BPZE1
BPZE1- middle doseExperimental100,000 colony forming units (cfu) of BPZE1
Receives: Biological: BPZE1
BPZE1 - High doseExperimental10,000,000 colony forming units (cfu) of BPZE1
Receives: Biological: BPZE1
PlaceboPlacebo comparatorFormulation buffer
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General safety and local tolerability in the respiratory tract of a single ascending dose of the genetically modified B. pertussis strain

    To determine

    • general safety, i. e. general well-being of the volunteers and any symptoms felt by the volunteers with onset within one month after vaccine administration.
    • vital signs: Blood pressure, heart rate, respiratory rate, oral temperature.
    • abnormalities in the following laboratory data: Haemoglobin, total and differential white blood cell count, platelets (thrombocytes).
    • specific side effects: Local symptoms from the respiratory tract: Sneezing, swollen nose, cough, bleeding from the nose, pain or other symptoms from the ear, symptoms from the eyes (redness, secretion).

    Measured: 6 months

Secondary outcomes (2)

  1. Attachment of the BPZE1 strain to the nasopharyngeal mucosa

    Detection of colonizing BPZE1 bacteria in nasopharyngeal culture

    Measured: Up to 50 days after vaccination

  2. Immunogenicity

    Immune responses will be determined by serum IgG and IgA, IgG and IgA in saliva and nasopharyngeal aspirate, cytokines and numbers of effector and memory T and B cells after stimulation with the various B. pertussis antigens.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJun 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01188512
Sponsor's protocol ID
BT06-04
Other IDs
2010-019936-11
Status last verified
Jan 2012
First submitted
24 Aug 2010
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Mielcarek N, Debrie AS, Raze D, Bertout J, Rouanet C, Younes AB, Creusy C, Engle J, Goldman WE, Locht C. Live attenuated B. pertussis as a single-dose nasal vaccine against whooping cough. PLoS Pathog. 2006 Jul;2(7):e65. doi: 10.1371/journal.ppat.0020065.

    PubMed 16839199

  • Feunou PF, Ismaili J, Debrie AS, Huot L, Hot D, Raze D, Lemoine Y, Locht C. Genetic stability of the live attenuated Bordetella pertussis vaccine candidate BPZE1. Vaccine. 2008 Oct 23;26(45):5722-7. doi: 10.1016/j.vaccine.2008.08.018. Epub 2008 Aug 30.

    PubMed 18762220

  • Mielcarek N, Debrie AS, Mahieux S, Locht C. Dose response of attenuated Bordetella pertussis BPZE1-induced protection in mice. Clin Vaccine Immunol. 2010 Mar;17(3):317-24. doi: 10.1128/CVI.00322-09. Epub 2010 Jan 27.

    PubMed 20107007

  • Kavanagh H, Noone C, Cahill E, English K, Locht C, Mahon BP. Attenuated Bordetella pertussis vaccine strain BPZE1 modulates allergen-induced immunity and prevents allergic pulmonary pathology in a murine model. Clin Exp Allergy. 2010 Jun;40(6):933-41. doi: 10.1111/j.1365-2222.2010.03459.x. Epub 2010 Feb 22.

    PubMed 20184606

  • Skerry CM, Cassidy JP, English K, Feunou-Feunou P, Locht C, Mahon BP. A live attenuated Bordetella pertussis candidate vaccine does not cause disseminating infection in gamma interferon receptor knockout mice. Clin Vaccine Immunol. 2009 Sep;16(9):1344-51. doi: 10.1128/CVI.00082-09. Epub 2009 Jul 22.

    PubMed 19625486

  • Thorstensson R, Trollfors B, Al-Tawil N, Jahnmatz M, Bergstrom J, Ljungman M, Torner A, Wehlin L, Van Broekhoven A, Bosman F, Debrie AS, Mielcarek N, Locht C. A phase I clinical study of a live attenuated Bordetella pertussis vaccine--BPZE1; a single centre, double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally to healthy adult male volunteers. PLoS One. 2014 Jan 8;9(1):e83449. doi: 10.1371/journal.pone.0083449. eCollection 2014.

    PubMed 24421886

  • Jahnmatz M, Amu S, Ljungman M, Wehlin L, Chiodi F, Mielcarek N, Locht C, Thorstensson R. B-cell responses after intranasal vaccination with the novel attenuated Bordetella pertussis vaccine strain BPZE1 in a randomized phase I clinical trial. Vaccine. 2014 Jun 5;32(27):3350-6. doi: 10.1016/j.vaccine.2014.04.048. Epub 2014 Apr 29.

    PubMed 24793938

  • Schnoeller C, Roux X, Sawant D, Raze D, Olszewska W, Locht C, Openshaw PJ. Attenuated Bordetella pertussis vaccine protects against respiratory syncytial virus disease via an IL-17-dependent mechanism. Am J Respir Crit Care Med. 2014 Jan 15;189(2):194-202. doi: 10.1164/rccm.201307-1227OC.

    PubMed 24261996

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BPZE1 in people with Pertussis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General safety and local tolerability in the respiratory tract of a single ascending dose of the genetically modified B. pertussis strain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01188512, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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