CompletedPhase 2

Pertussis Challenge Study in Adults Vaccinated With BPZE1

United Kingdom53 participantsStarted 2022-06-20

Plain-language summary

This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Correctly answer all questions in the questionnaire provided during the consent process to ensure understanding of the study
✓. Willing to refrain from any nasal sprays (including intranasal steroid sprays) and nasal washes not part of the study for 14 days prior to vaccination (Day 0) and for 28 days following vaccination and challenge
✓. Non-smoker at the time of enrolment, has not smoked (or vaped) in the past 7 days prior to vaccination (including marijuana), and is willing not to smoke (or vape; including marijuana) from the time of vaccination throughout the challenge unit phase
✓. Sufficiently vaccinated (per site and local guidelines) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; proof of vaccination required) \>14 days prior to study vaccination
✓. Able to understand and comply with planned study procedures including admission for virulent challenge for 17 days and willingness to take the curative antibiotic regimen (azithromycin after inoculation with B. pertussis)
✓. Willing to provide written agreement to and abide by infection control rules from challenge until 1 week following completion of azithromycin eradication

✕. Body mass index \<17 or \>30 kg/m2
✕. History of being vaccinated against pertussis within 5 years of enrolment
✕. History of never being vaccinated for pertussis in lifetime
✕. A diagnosis of pertussis by laboratory confirmation or by physician diagnosis in the past 5 years
✕. Previously participated in a pertussis challenge study
✕. Screening laboratory values outside of the normal ranges
✕. Existing chronic disorders of lung, kidney, heart, liver, diabetes, immunodeficiency, autoimmune or significant neurologic condition
✕. Use of illicit drugs (excluding marijuana), evidenced by urine toxicology at Screening or a history of drug/alcohol abuse within the past 2 years

Number of Participants Colonized Following Virulent Challenge

Timeframe: Challenge Day 9, 11 or 14

NCT IDNCT05461131

SponsorILiAD Biotechnologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-25

Results submitted2024-10-24

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Correctly answer all questions in the questionnaire provided during the consent process to ensure understanding of the study
✓. Willing to refrain from any nasal sprays (including intranasal steroid sprays) and nasal washes not part of the study for 14 days prior to vaccination (Day 0) and for 28 days following vaccination and challenge
✓. Non-smoker at the time of enrolment, has not smoked (or vaped) in the past 7 days prior to vaccination (including marijuana), and is willing not to smoke (or vape; including marijuana) from the time of vaccination throughout the challenge unit phase
✓. Sufficiently vaccinated (per site and local guidelines) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; proof of vaccination required) \>14 days prior to study vaccination
✓. Able to understand and comply with planned study procedures including admission for virulent challenge for 17 days and willingness to take the curative antibiotic regimen (azithromycin after inoculation with B. pertussis)
✓. Willing to provide written agreement to and abide by infection control rules from challenge until 1 week following completion of azithromycin eradication

✕. Body mass index \<17 or \>30 kg/m2
✕. History of being vaccinated against pertussis within 5 years of enrolment
✕. History of never being vaccinated for pertussis in lifetime
✕. A diagnosis of pertussis by laboratory confirmation or by physician diagnosis in the past 5 years
✕. Previously participated in a pertussis challenge study
✕. Screening laboratory values outside of the normal ranges
✕. Existing chronic disorders of lung, kidney, heart, liver, diabetes, immunodeficiency, autoimmune or significant neurologic condition
✕. Use of illicit drugs (excluding marijuana), evidenced by urine toxicology at Screening or a history of drug/alcohol abuse within the past 2 years