Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine
Condition: Pertussis; Whooping Cough
MeSH terms: Whooping Cough
Intervention: BPZE1; Placebo
Intervention description: Intranasal live, attenuated vaccine; Diluent
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 32 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pertussis; Colonization; Vaccine; Immune response; BPZE1; Infection; Bordetella pertussis; B. pertussis; respiratory Tract Infection

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 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.