Pertussis/Whooping CoughPhase 2CHAMPION-1NCT05461131
Pertussis Challenge Study in Adults Vaccinated With BPZE1
A Phase 2 study testing BPZE1, Azithromycin and Bordetella Pertussis Challenge Strain in people with Pertussis/Whooping Cough and Bordetella Pertussis, Whooping Cough, run by ILiAD Biotechnologies at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis/Whooping Cough, Bordetella Pertussis, Whooping Cough
- What is being tested?
- BPZE1, Azithromycin and Bordetella Pertussis Challenge Strain
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Jun 2022to 26 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Oxford Vaccine Group
Oxford
University Hospital Southampton
Southampton
About this study
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
This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.
Read the 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.
- Being tested
- BPZE1, Placebo, Azithromycin, Bordetella Pertussis Challenge Strain
- Keywords
- Bordetella Pertussis, BPZE1, Vaccine, Live Attenuated Vaccine, Challenge Study
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPZE1Biological
Live attenuated vaccine
PlaceboBiological
Placebo
AzithromycinDrug
Antibiotic
Bordetella Pertussis Challenge StrainOther
Challenge Strain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placebo; Drug: Azithromycin; Other: Bordetella Pertussis Challenge Strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Challenge Day 9, 11 or 14
Secondary outcomes (7)
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])
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start20 Jun 2022
- Primary completion25 Jul 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pertussis/Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILiAD Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461131
- Sponsor's protocol ID
- IB-202P
- Acronym
- CHAMPION-1
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2022
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 41344352
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05461131
- Acronym / sponsor ID
- CHAMPION-1 / IB-202P
- Keywords
- Bordetella Pertussis, BPZE1, Vaccine, Live Attenuated Vaccine, Challenge Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- ILiAD BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPZE1 | Experimental | Biological: BPZE1, Drug: Azithromycin, Other: Bordetella Pertussis Challenge StrainParticipants 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 | Biological: Placebo, Drug: Azithromycin, Other: Bordetella Pertussis Challenge StrainParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPZE1Live attenuated vaccine | Biological | BPZE1 |
| PlaceboPlacebo | Biological | Placebo |
| AzithromycinAntibiotic | Drug | BPZE1, Placebo |
| Bordetella Pertussis Challenge StrainChallenge Strain | Other | BPZE1, Placebo |
Primary outcome
Number of Participants Colonized Following Virulent Challenge
Time frame: Challenge Day 9, 11 or 14
Participants by treatment group (BPZE1 and placebo) colonized on any day (Challenge Day 9, 11 or 14) following virulent challenge as determined by culture.
7 secondary outcomes
GMFR of Mucosal Anti-pertussis S-IgA Antibody
Time frame: Day 28
GMFR of Serum IgA Antibody
Time frame: Day 28
GMFR of Serum IgG Antibody
Time frame: Day 28
Safety: Number of Participants With Solicited AEs for Reactogenicity
Time frame: Day 7
Safety: Number of Participants With Treatment Emergent Adverse Events
Time frame: Day 28
Safety: Number of Participants With TEAEs Related to Vaccination or Related to Challenge
Time frame: Day 60-120 post vaccination and Day 90 post challenge
Safety: Number of Participants With AESI and SAE
Time frame: Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41344352Gbesemete 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPZE1, Azithromycin and Bordetella Pertussis Challenge Strain in people with Pertussis/Whooping Cough and Bordetella Pertussis, Whooping Cough, run by ILiAD Biotechnologies at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Colonized Following Virulent Challenge (time frame: Challenge Day 9, 11 or 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.