Pertussis Challenge Study in Adults Vaccinated With BPZE1

NCT05461131 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IB-202P
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Pertussis/Whooping Cough; Bordetella Pertussis, Whooping Cough

Keywords

Bordetella Pertussis; BPZE1; Vaccine; Live Attenuated Vaccine; Challenge Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• GMFR of Mucosal Anti-pertussis S-IgA Antibody

  Day 28

• GMFR of Serum IgA Antibody

  Day 28

• GMFR of Serum IgG Antibody

  Day 28

• Safety: Number of Participants With Solicited AEs for Reactogenicity

  Day 7

• Safety: Number of Participants With Treatment Emergent Adverse Events

  Day 28

Study Arms (2)

BPZE1

EXPERIMENTAL

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.

Biological: BPZE1; Drug: Azithromycin; Other: Bordetella Pertussis Challenge Strain

Placebo

PLACEBO COMPARATOR

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; Drug: Azithromycin; Other: Bordetella Pertussis Challenge Strain

Interventions

BPZE1 BIOLOGICAL

Live attenuated vaccine

BPZE1

Placebo BIOLOGICAL

Placebo

Placebo

Azithromycin DRUG

Antibiotic

BPZE1; Placebo

Bordetella Pertussis Challenge Strain OTHER

Challenge Strain

BPZE1; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ILiAD Biotechnologies: lead

Study Sites (2)

Oxford Vaccine Group

Oxford, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Related Publications (1)

• Gbesemete D, Ramasamy MN, Ibrahim M, Hill AR, Raud L, Ferreira DM, Guy J, Dale AP, Laver JR, Coutinho T, Faust SN, Reed TAN, Babbage G, Weissfeld L, Lang W, Locht C, Samal V, Goldstein P, Solovay K, Rubin K, Noviello S, Read RC. Efficacy, immunogenicity, and safety of the live attenuated nasal pertussis vaccine, BPZE1, in the UK: a randomised, placebo-controlled, phase 2b trial using a controlled human infection model with virulent Bordetella pertussis. Lancet Microbe. 2025 Dec;6(12):101211. doi: 10.1016/j.lanmic.2025.101211. Epub 2025 Dec 1.

  PMID: 41344352 DERIVED

MeSH Terms

Conditions

Whooping Cough

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: ILiAD Biotechnologies

contact@iliadbiotech.com

800-603-3525

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: June 20, 2022
• Primary Completion: July 25, 2023
• Study Completion: October 26, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-03

Locations

GB (2)