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

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Brief Title

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

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

Brief 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.

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Attachment of the BPZE1 strain to the nasopharyngeal mucosa

Condition

Pertussis

Intervention

BPZE1

Study Arms / Comparison Groups

 BPZE1 - Low dose
Description:  1,000 colony forming units (cfu) of BPZE1

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

48

Start Date

August 2010

Completion Date

January 2012

Primary Completion Date

June 2011

Eligibility Criteria

        Inclusion Criteria:

        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).

        Exclusion Criteria:

        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.

          -  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.
      

Gender

Male

Ages

19 Years - 31 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Camille Locht, PhD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT01188512

Organization ID

BT06-04

Secondary IDs

2010-019936-11

Responsible Party

Sponsor

Study Sponsor

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

Collaborators

 European Union

Study Sponsor

Camille Locht, PhD, Study Director, Institut National de la Santé Et de la Recherche Médicale, France


Verification Date

January 2012