Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in H… (NCT03942406) | Clinical Trial Compass
CompletedPhase 2
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
United States300 participantsStarted 2019-06-15
Plain-language summary
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose (prime + boost) to a single (prime) Boostrix or Boostrix prime + BPZE1 boost.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Is a male or nonpregnant female 18 to 50 years of age, inclusive, on Day 1 (primary vaccination).
✓. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
✓. Female subjects must be nonpregnant and nonlactating and meet 1 of the following criteria:
✓. Postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause or documented plasma follicle-stimulating hormone level in the postmenopausal range);
✓. Is of childbearing potential (defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal), agrees to be heterosexually inactive from at least 21 days prior to enrollment and through 3 months after the boosting vaccination or agrees to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 3 months after the boosting vaccination:
✓. Has a stable health status as assessed by the investigator, as established by physical examination, vital sign measurements, and medical history.
✓. Has access to a consistent and reliable means of telephone contact, which may be in the home, workplace, or by personal mobile electronic device.
Exclusion criteria
✕. History of being vaccinated in the past 5 years against pertussis.
What they're measuring
1
Number of Participants With Nasal Mucosal Seroconversion (Immunoglobulin A [IgA])
Timeframe: Days 29 and 113
2
Safety - Number of Participants With Nasal/Respiratory Solicited Adverse Events (AEs)
Timeframe: Through 7 Days Following Day 1 Vaccination
3
Safety - Number of Participants With Local Solicited AEs
Timeframe: Through 7 Days Following Day 1 Vaccination
4
Safety - Number of Participants With Systemic Solicited AEs
Timeframe: Through 7 Days Following Day 1 Vaccination
. Any significant past reaction to any component of Boostrix (at the discretion of the investigator).
✕. Subject reported diagnosis of pertussis in the past 10 years (must be laboratory confirmed or physician diagnosed from medical records).
✕. Vital signs by FDA toxicity scoring \>1 (may be repeated once during the screening period to allow for inclusion and the most recent measurement taken at baseline).
✕. Chronic illness being treated actively and with evidence of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator).
✕. The subject has a history of active cancer (malignancy) in the last 10 years (exception is subjects with adequately treated non melanomatous skin carcinoma, who may participate in the study).
✕. Current use of any smoking products and unwillingness to refrain from the use of any smoking products from screening through 28 days after the boosting vaccination.
✕. Use of narcotic drugs, evidenced by urine toxicology screen or a history of drug/alcohol abuse within the past 2 years.