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

January 27, 2012 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Solna, Sweden, 171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 31 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Formulation buffer
Biological: Placebo
Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).
Experimental: BPZE1 - Low dose
1,000 colony forming units (cfu) of BPZE1
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).
Experimental: BPZE1- middle dose
100,000 colony forming units (cfu) of BPZE1
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).
Experimental: BPZE1 - High dose
10,000,000 colony forming units (cfu) of BPZE1
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 50 days after vaccination
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

European Union
Swedish Institute for Infectious Disease Control
Innogenetics

Investigators

  • Principal Investigator: Nabil Al-Tawil, MD, PhD, Karolinska Trial Alliance
  • Study Director: Camille Locht, PhD, Institut National de la Santé Et de la Recherche Médicale, France
  • Principal Investigator: Rigmor Thorstensson, PhD, Swedish Institute for Infectious Disease Control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT06-04
  • 2010-019936-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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