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

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ClinicalTrials.gov Identifier: NCT02453048
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pertussis Whooping Cough Biological: BPZE1 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BPZE1 - 10,000,000 cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 or Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).
 Biological: BPZE1
Intranasal live, attenuated vaccine

Other: Placebo
Diluent
Experimental: BPZE1 - 100,000,000 cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 or Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).
 Biological: BPZE1
Intranasal live, attenuated vaccine

Other: Placebo
Diluent
Experimental: BPZE1 - 1,000,000,000 cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 or Placebo at a Dose 2 x 0.4 mL (0.4 mL per nostril).
 Biological: BPZE1
Intranasal live, attenuated vaccine

Other: Placebo
Diluent
Experimental: BPZE1 - High Antibody 1,000,000,000 cfu
Individuals will be vaccinated once intranasally with the designated dose of BPZE1 at a Dose 2 x 0.4 mL (0.4 mL per nostril).
 Biological: BPZE1
Intranasal live, attenuated vaccine


Outcome Measures
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Primary Outcome Measures :
  1. The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28 [ Time Frame: 28 days ]

    Percentage is based on subjects experiencing at least one of the following events:

    • Cough and spasmodic cough of grade 2 or higher
    • Other respiratory tract AE related or possibly related to vaccination of grade 3 or higher
    • Any other AE related or possibly related to vaccination of grade 3 or higher


Secondary Outcome Measures :
  1. Proportion of Subjects With BPZE1 Colonization [ Time Frame: 28 days ]
    To assess the proportion of subjects having positive colonization of the human respiratory tract by live attenuated B. pertussis strain BPZE1 per group at any time period measured at 4, 7, 11, 14, 21 and 28 days post vaccination.

  2. The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination [ Time Frame: 6 months ]

    To assess the number of immune responders and levels of Immunoglobulin G/Immunoglobulin A (IgG/IgA) antibodies to pertussis toxin (PT), filamentous haemagglutinin adhesin (FHA), Pertactin (PRN), and fimbriae 2/3 in serum and nasopharyngeal aspirate.

    A positive antibody response after vaccination is defined as at least 100% increase from pre- to post-vaccination, to at least 4 times minimum level of detection (MLD) for PT, FHA, PRN, and fimbriae 2/3 in the post-vaccination sample. The 4 antigens described are the standard 4 antigens historically used to describe a serum immunological response to B. pertussis. The absolute serum antibody titers have not shown a correlation of protection in previous pertussis vaccine studies of the current acellular vaccine and there is no known serum antigen threshold of protection for pertussis.

    Antibodies are measured before vaccination and at 4, 7, 11, 14, 21, 28 days, 6-months and 12-months post-vaccination.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  11. Asthma or other chronic respiratory problems.
  12. Use of corticosteroids in the respiratory tract (e.g. nasal steroids, inhaled steroids) with in 30 days prior to day 0.
  13. Receipt of a vaccine within the last 30 days prior to day 0 or planned vaccination with in the next 30 days after day 0.
  14. Known hypersensitivity to any component of the study vaccine.
  15. 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.
  16. Inability to adhere to the protocol, including plans to move from the area.
  17. Family (first degree) history of congenital or hereditary immunodeficiency.
  18. Past or present infection with HIV, hepatitis B or C.
  19. Chronic conditions requiring ongoing active medical interventions, such as diabetes mellitus or cardiovascular disease.
  20. Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic).
  21. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might affect the safety of the individual, e.g. evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine, hospitalization due to major depression or history of suicidal attempt.
  22. Abnormal laboratory values outside the limit of normal values for the screening laboratory with clinical significance at the discretion of the investigator.
  23. Person in frequent contact with children less than 1 year of age (parent, childcare worker, nurse, etc) or residence in the same household as persons with known immunodeficiency including persons on immunosuppressant therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453048


Locations
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Sweden
Karolinska University Hospital
Huddinge, Stockholm, Sweden, 141 86
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Nabil Al-Tawil, MD, PhD Karolinska University Hospital
  Study Documents (Full-Text)

Documents provided by Institut National de la Santé Et de la Recherche Médicale, France:
Study Protocol and Statistical Analysis Plan  [PDF] May 9, 2016

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02453048    
Other Study ID Numbers: C14-80
2015-001287-20 ( EudraCT Number )
First Posted: May 25, 2015    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Pertussis
Colonization
Vaccine
Immune response
BPZE1
 Infection
Bordetella pertussis
B. pertussis
respiratory Tract Infection
Additional relevant MeSH terms:
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Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Respiratory Tract Diseases