Pertussis Challenge Study in Adults Vaccinated With BPZE1

Bordetella Pertussis, Whooping Cough Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461131
• Other study ID #: IB-202P
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2022
• Est. completion date: October 26, 2023

Study information

• Verified date: February 2024
• Source: ILiAD Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 26, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bordetella Pertussis, Whooping Cough
• Cough
• Pertussis/Whooping Cough
• Whooping Cough

Intervention

Biological:
• BPZE1
Live attenuated vaccine
• Placebo
Placebo

Drug:
• Azithromycin
Antibiotic

Other:
• Bordetella Pertussis Challenge Strain
Challenge Strain

Locations

Country	Name	City	State
United Kingdom	Oxford Vaccine Group	Oxford
United Kingdom	University Hospital Southampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
ILiAD Biotechnologies

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 9 - 14
Secondary	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
Secondary	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
Secondary	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
Secondary	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)	Day 7
Secondary	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)	Day 28
Secondary	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)	Day 60-120 post vaccination and Day 90 post challenge
Secondary	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)	Day 180