- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05461131
Pertussis Challenge Study in Adults Vaccinated With BPZE1 (CHAMPION-1)
February 20, 2024 updated by: ILiAD Biotechnologies
A Phase 2b, Placebo-Controlled, Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy Adults to Assess Protection Against Colonization Following Challenge With Virulent Wild-Type Bordetella Pertussis
This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This Phase 2b challenge study will investigate colonisation rates, immunologic response, and the safety of BPZE1 vaccination to potentially protect against colonising, virulent wild-type B. pertussis infection in healthy adults using a virulent challenge model.
Consenting, eligible participants will receive a single dose of BPZE1 or placebo.
2-4 months later they will be challenged with B. pertussis and admitted to a challenge unit.
Participants will remain in the challenge unit for a total of 17 days and 16 nights during which time they will be monitored closely.
If a participant develops symptoms of pertussis (per investigator discretion), antibiotic (azithromycin) will be started and the participant will remain in the unit for 3 additional days of observation before discharge.
If symptoms of pertussis do not develop, then participants will receive antibiotic (azithromycin) from Days 14-16 of the challenge unit stay.
Participants will undergo safety follow-up for at least 6 months post-vaccination and at least 3 months post-challenge, for a total follow-up of 6-7 months.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ILiAD Biotechnologies
- Phone Number: (954) 907-6471
- Email: ClinicalTrials@iliadbiotech.com
Study Locations
-
-
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Oxford, United Kingdom
- Oxford Vaccine Group
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Southampton, United Kingdom
- University Hospital Southampton
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-
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Key Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- History of active cancer (malignancy) in the last 10 years (except for adequately treated non-melanomatous skin carcinoma)
- History of Guillain-Barré syndrome (genetic/congenital or acquired)
- History of head trauma with potential of cribriform plate fracture within 1 year prior to Day 0
- History of nasal or sinus surgery within 6 months or receipt of facial cosmetic fillers within 3 months prior to Day 0 or diagnosis of nasal polyps
- Received immunosuppressive therapy or other immune-modifying drugs (including but not limited to systemic corticosteroids, biologics and methotrexate) in the past 6 months, is on scheduled immunosuppressive therapy or is planning to start immunosuppressive therapy during the trial.
- Received immunoglobulins or any blood products within 3 months prior to study vaccine administration or planned receipt during the study
- Lives in the same home or has routine contact (face to face <2 meters) with persons with known immunodeficiency including persons on immunosuppressant therapy, from study vaccination to challenge and for 1 week after exiting the challenge unit
- Resides in the same home, works regularly with, or has contact (face to face <2 meters), with infants less than 1 year of age, partially immunised infants or pregnant women, adults >65 years of age who have not received a dose of acellular pertussis vaccine (e.g. Tdap) within the past 10 years from study vaccination to challenge and for 1 week after exiting the challenge unit
- Known hypersensitivity to any component of the study vaccine
- Contraindications or allergic to azithromycin, erythromycin or other macrolide antibiotics
- Taking medication that may interact with azithromycin (e.g., nelfinavir, warfarin, digoxin and phenytoin)
- Inability to adhere to the protocol, visit schedule or sample collection needs (including housing in the challenge unit)
- Participation in any other clinical trial for the testing of an unlicensed product during the previous 3 months or planned during the study conduct
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 |
---|---|
Experimental: BPZE1
Participants will receive an intranasal dose of BPZE1 via the mucosal atomization device followed by a dose of the challenge strain (B.
Pertussis strain 1917) approximately 60-120 days later.
Participants will receive azythromycin for 3 days beginning 14 days after after administration of the challenge strain.
|
Antibiotic
Live attenuated vaccine
Challenge Strain
|
Placebo Comparator: Placebo
Participants will receive an intranasal dose of placebo via the mucosal atomization device followed by a dose of the challenge strain (B.
Pertussis strain 1917) approximately 60-120 days later.
Participants will receive azythromycin for 3 days beginning14 days after after administration of the challenge strain.
|
Placebo
Antibiotic
Challenge Strain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants colonized following virulent challenge
Time Frame: Day 9 - 14
|
Participants by treatment group (BPZE1 and placebo) colonised on any day following virulent challenge as determined by culture.
|
Day 9 - 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GMFR of mucosal anti-pertussis S-IgA antibody
Time Frame: Day 28
|
The geometric mean fold rise (GMFR) of mucosal anti-pertussis S-IgA antibody (whole cell extract [WCE], FHA, PRN, PT and fimbriae types 2 and 3 [FIM2/3]) from baseline to Day 28 (BPZE1 and placebo).
Secretory IgA to be normalized ([specific S-IgA]/[total S-IgA])
|
Day 28
|
GMFR of serum IgA antibody
Time Frame: Day 28
|
The GMFR of serum IgA antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
|
Day 28
|
GMFR of serum IgG antibody
Time Frame: Day 28
|
The GMFR of serum IgG antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
|
Day 28
|
Safety: Solicited AEs for reactogenicity
Time Frame: Day 7
|
Occurrence and intensity of solicited AEs for nasal/respiratory and systemic reactogenicity through 7 days following vaccination by treatment group (BPZE1 and placebo)
|
Day 7
|
Safety: Treatment Emergent Adverse Events
Time Frame: Day 28
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Occurrence and intensity of TEAEs through 28 days following study vaccination and following challenge by treatment group (BPZE1 and placebo)
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Day 28
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Safety: TEAEs
Time Frame: Day 60-120 post vaccination and Day 90 post challenge
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Occurrence and intensity of TEAEs related to vaccination from time of vaccination to challenge or related to challenge for 3 months after challenge by treatment group (BPZE1 and placebo)
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Day 60-120 post vaccination and Day 90 post challenge
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Safety: AESI and SAE
Time Frame: Day 180
|
Occurrence, intensity, and relationship to study vaccine of AESIs and SAEs from vaccination through end of study (EOS) by treatment group (BPZE1 and placebo)
|
Day 180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 20, 2022
Primary Completion (Actual)
July 25, 2023
Study Completion (Actual)
October 26, 2023
Study Registration Dates
First Submitted
July 13, 2022
First Submitted That Met QC Criteria
July 13, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Signs and Symptoms, Respiratory
- Whooping Cough
- Cough
- Anti-Infective Agents
- Anti-Bacterial Agents
- Azithromycin
Other Study ID Numbers
- IB-202P
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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