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This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPZE1 | Biological | Live attenuated vaccine |
| |
| Placebo |
| 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 |
| 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 |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Vaccine Group | Oxford | United Kingdom | ||||
| University Hospital Southampton |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41344352 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. BPZE1: Live attenuated B. pertussis vaccine Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain |
| FG001 | 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. Placebo: Placebo Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. BPZE1: Live attenuated B. pertussis vaccine Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects who received an adequate inoculum defined prospectively as challenge dose >=0.5x10^5 CFU were evaluated. | Posted | Count of Participants | Participants | Challenge Day 9, 11 or 14 |
|
SAEs and deaths collected through end of study - up to 7 months. Unsolicited AEs collected up to 28 days post-vaccination and 28 days post-challenge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. BPZE1: Live attenuated B. pertussis vaccine Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | ILiAD Biotechnologies | 800-603-3525 | contact@iliadbiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2023 | Oct 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2023 | Oct 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Biological |
Placebo |
|
| Azithromycin | Drug | Antibiotic |
|
| Bordetella Pertussis Challenge Strain | Other | Challenge Strain |
|
| 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 |
| Southampton |
| United Kingdom |
| BG001 | 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. Placebo: Placebo Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Placebo: Placebo Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain |
|
|
| 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]) | Available baseline and Day 28 samples | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Fold Rise | 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) | Available baseline and Day 28 samples | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Fold Rise | 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) | Available baseline and Day 28 samples | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Fold Rise | Day 28 |
|
|
|
| Secondary | 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) | Safety analysis set | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| Secondary | 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) | Safety analysis set | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | 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) | Safety analysis set | Posted | Count of Participants | Participants | Day 60-120 post vaccination and Day 90 post challenge |
|
|
|
| Secondary | 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) | Safety analysis set | Posted | Count of Participants | Participants | Day 180 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 7 |
| 26 |
| EG001 | 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. Placebo: Placebo Azithromycin: Antibiotic Bordetella Pertussis strain 1917 Challenge: Challenge Strain | 0 | 27 | 0 | 27 | 9 | 27 |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
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| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| Organic Chemicals |
| PRN |
|
| PT |
|
| FIM 2/3 |
|
| PRN |
|
| PT |
|
| FIM 2/3 |
|
| PRN |
|
| PT |
|
| FIM 2/3 |
|