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Trial record 3 of 3 for:    BPZE1 | Pertussis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01188512
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : January 31, 2012
Sponsor:
Collaborators:
European Union
Swedish Institute for Infectious Disease Control
Innogenetics
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE August 24, 2010
First Posted Date  ICMJE August 25, 2010
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
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 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01188512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • Attachment of the BPZE1 strain to the nasopharyngeal mucosa [ Time Frame: Up to 50 days after vaccination ]
    Detection of colonizing BPZE1 bacteria in nasopharyngeal culture
  • Immunogenicity [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pertussis
Intervention  ICMJE
  • Biological: BPZE1
    Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
  • Biological: Placebo
    Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).
Study Arms  ICMJE
  • Experimental: BPZE1 - Low dose
    1,000 colony forming units (cfu) of BPZE1
    Intervention: Biological: BPZE1
  • Experimental: BPZE1- middle dose
    100,000 colony forming units (cfu) of BPZE1
    Intervention: Biological: BPZE1
  • Experimental: BPZE1 - High dose
    10,000,000 colony forming units (cfu) of BPZE1
    Intervention: Biological: BPZE1
  • Placebo Comparator: Placebo
    Formulation buffer
    Intervention: Biological: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2010)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 31 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01188512
Other Study ID Numbers  ICMJE BT06-04
2010-019936-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE
  • European Union
  • Swedish Institute for Infectious Disease Control
  • Innogenetics
Investigators  ICMJE
Study Director: Camille Locht, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Nabil Al-Tawil, MD, PhD Karolinska Trial Alliance
Principal Investigator: Rigmor Thorstensson, PhD Swedish Institute for Infectious Disease Control
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP