Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine (NCT02453048) | Clinical Trial Compass
CompletedPhase 1
Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine
Sweden54 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range18 Years – 32 Years
SexALL
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Inclusion criteria
✓. Healthy individual between 18 and 32 years of age, vaccinated or unvaccinated with acellular pertussis vaccine.
✓. 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).
✓. Informed consent form (ICF) signed by the subject.
✓. Subject shall be able to attend all scheduled visits and to understand and comply with the study procedures.
Exclusion criteria
✕. 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.
✕. Vaccinated with the study vaccine in the Child Innovac study (EudraCT number 2010-019936-11).
✕. Pregnant or lactating women. Pregnancy not planned and to be avoided during the study by use of effective contraceptive methods.
✕. Blood pressure after resting ≥ 150/90 mm Hg at screening.
✕. Heart rate after resting ≥ 80 bpm at screening.
✕. Respiratory rate after resting ≥ 20/minute at screening.
✕. Unwillingness to refrain from the use of nicotine products from screening through day 28.
✕
What they're measuring
1
The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28