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Pertussis Challenge Study in Adults Vaccinated With BPZE1 (CHAMPION-1)

Primary Purpose

Pertussis/Whooping Cough, Bordetella Pertussis, Whooping Cough

Status
Active
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
BPZE1
Placebo
Azithromycin
Bordetella Pertussis Challenge Strain
Sponsored by
ILiAD Biotechnologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pertussis/Whooping Cough focused on measuring Bordetella Pertussis, BPZE1, Vaccine, Live Attenuated Vaccine, Challenge Study

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  1. Correctly answer all questions in the questionnaire provided during the consent process to ensure understanding of the study
  2. 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
  3. 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
  4. 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
  5. 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)
  6. Willing to provide written agreement to and abide by infection control rules from challenge until 1 week following completion of azithromycin eradication

Exclusion Criteria:

  1. Body mass index <17 or >30 kg/m2
  2. History of being vaccinated against pertussis within 5 years of enrolment
  3. History of never being vaccinated for pertussis in lifetime
  4. A diagnosis of pertussis by laboratory confirmation or by physician diagnosis in the past 5 years
  5. Previously participated in a pertussis challenge study
  6. Screening laboratory values outside of the normal ranges
  7. Existing chronic disorders of lung, kidney, heart, liver, diabetes, immunodeficiency, autoimmune or significant neurologic condition
  8. Use of illicit drugs (excluding marijuana), evidenced by urine toxicology at Screening or a history of drug/alcohol abuse within the past 2 years
  9. History of active cancer (malignancy) in the last 10 years (except for adequately treated non-melanomatous skin carcinoma)
  10. History of Guillain-Barré syndrome (genetic/congenital or acquired)
  11. History of head trauma with potential of cribriform plate fracture within 1 year prior to Day 0
  12. 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
  13. 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.
  14. Received immunoglobulins or any blood products within 3 months prior to study vaccine administration or planned receipt during the study
  15. 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
  16. 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
  17. Known hypersensitivity to any component of the study vaccine
  18. Contraindications or allergic to azithromycin, erythromycin or other macrolide antibiotics
  19. Taking medication that may interact with azithromycin (e.g., nelfinavir, warfarin, digoxin and phenytoin)
  20. Inability to adhere to the protocol, visit schedule or sample collection needs (including housing in the challenge unit)
  21. Participation in any other clinical trial for the testing of an unlicensed product during the previous 3 months or planned during the study conduct

Sites / Locations

  • Oxford Vaccine Group
  • University Hospital Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BPZE1

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants colonized following virulent challenge
Participants by treatment group (BPZE1 and placebo) colonised on any day following virulent challenge as determined by culture.

Secondary Outcome Measures

GMFR of mucosal anti-pertussis S-IgA antibody
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])
GMFR of serum IgA antibody
The GMFR of serum IgA antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
GMFR of serum IgG antibody
The GMFR of serum IgG antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Safety: Solicited AEs for reactogenicity
Occurrence and intensity of solicited AEs for nasal/respiratory and systemic reactogenicity through 7 days following vaccination by treatment group (BPZE1 and placebo)
Safety: Treatment Emergent Adverse Events
Occurrence and intensity of TEAEs through 28 days following study vaccination and following challenge by treatment group (BPZE1 and placebo)
Safety: TEAEs
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)
Safety: AESI and SAE
Occurrence, intensity, and relationship to study vaccine of AESIs and SAEs from vaccination through end of study (EOS) by treatment group (BPZE1 and placebo)

Full Information

First Posted
July 13, 2022
Last Updated
August 2, 2023
Sponsor
ILiAD Biotechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT05461131
Brief Title
Pertussis Challenge Study in Adults Vaccinated With BPZE1
Acronym
CHAMPION-1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ILiAD Biotechnologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis/Whooping Cough, Bordetella Pertussis, Whooping Cough
Keywords
Bordetella Pertussis, BPZE1, Vaccine, Live Attenuated Vaccine, Challenge Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPZE1
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
BPZE1
Intervention Description
Live attenuated vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Antibiotic
Intervention Type
Other
Intervention Name(s)
Bordetella Pertussis Challenge Strain
Intervention Description
Challenge Strain
Primary Outcome Measure Information:
Title
Number of participants colonized following virulent challenge
Description
Participants by treatment group (BPZE1 and placebo) colonised on any day following virulent challenge as determined by culture.
Time Frame
Day 9 - 14
Secondary Outcome Measure Information:
Title
GMFR of mucosal anti-pertussis S-IgA antibody
Description
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])
Time Frame
Day 28
Title
GMFR of serum IgA antibody
Description
The GMFR of serum IgA antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Time Frame
Day 28
Title
GMFR of serum IgG antibody
Description
The GMFR of serum IgG antibody (WCE, FHA, PRN, PT and FIM2/3) from baseline to Day 28 (BPZE1 and placebo)
Time Frame
Day 28
Title
Safety: Solicited AEs for reactogenicity
Description
Occurrence and intensity of solicited AEs for nasal/respiratory and systemic reactogenicity through 7 days following vaccination by treatment group (BPZE1 and placebo)
Time Frame
Day 7
Title
Safety: Treatment Emergent Adverse Events
Description
Occurrence and intensity of TEAEs through 28 days following study vaccination and following challenge by treatment group (BPZE1 and placebo)
Time Frame
Day 28
Title
Safety: TEAEs
Description
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)
Time Frame
Day 60-120 post vaccination and Day 90 post challenge
Title
Safety: AESI and SAE
Description
Occurrence, intensity, and relationship to study vaccine of AESIs and SAEs from vaccination through end of study (EOS) by treatment group (BPZE1 and placebo)
Time Frame
Day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Oxford Vaccine Group
City
Oxford
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

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Pertussis Challenge Study in Adults Vaccinated With BPZE1

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