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

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
• Conditions: Pertussis/Whooping Cough; Bordetella Pertussis, Whooping Cough
• Intervention / Treatment: Biological: Placebo; Drug: Azithromycin; Biological: BPZE1; Other: Bordetella Pertussis Challenge Strain

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

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Oxford Vaccine Group
  • Southampton, United Kingdom
    • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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 azithromycin for 3 days beginning 14 days after administration of the challenge strain.	Drug: Azithromycin; Antibiotic; Biological: BPZE1; Live attenuated vaccine; Other: Bordetella Pertussis Challenge Strain; 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 azithromycin for 3 days beginning 14 days after administration of the challenge strain.	Biological: Placebo; Placebo; Drug: Azithromycin; Antibiotic; Other: Bordetella Pertussis Challenge Strain; Challenge Strain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Colonized Following Virulent Challenge	Participants by treatment group (BPZE1 and placebo) colonized on any day (Challenge Day 9, 11 or 14) following virulent challenge as determined by culture.	Challenge Day 9, 11 or 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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])	Day 28
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)	Day 28
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)	Day 28
Safety: Number of Participants With 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)	Day 7
Safety: Number of Participants With Treatment Emergent Adverse Events	Occurrence and intensity of TEAEs through 28 days following study vaccination and following challenge by treatment group (BPZE1 and placebo)	Day 28
Safety: Number of Participants With TEAEs Related to Vaccination or Related to Challenge	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)	Day 60-120 post vaccination and Day 90 post challenge
Safety: Number of Participants With 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)	Day 180

Collaborators and Investigators

• Sponsor: ILiAD Biotechnologies

Study record dates

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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; Challenge Study; Live Attenuated Vaccine; Bordetella Pertussis; BPZE1
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Bordetella Infections; Cough; Whooping Cough; Anti-Bacterial Agents; Anti-Infective 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