First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine (NCT01188512) | Clinical Trial Compass
CompletedPhase 1
First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine
Sweden48 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range19 Years – 31 Years
SexMALE
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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 s…
What they're measuring
1
General safety and local tolerability in the respiratory tract of a single ascending dose of the genetically modified B. pertussis strain