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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05116241




Registration number
NCT05116241
Ethics application status
Date submitted
20/10/2021
Date registered
10/11/2021
Date last updated
1/12/2023

Titles & IDs
Public title
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
Scientific title
Phase 2b Placebo-Controlled Randomized Study of BPZE1 Intranasal Pertussis Vaccine in Healthy School-Age Children to Assess Immunological Response and Safety of a Single Dose BPZE1 With/Without Coadministration of Tdap (Boostrix™)
Secondary ID [1] 0 0
IB-201P
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bordetella Pertussis, Whooping Cough 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BPZE1 pertussis vaccine and placebo
Other interventions - BPZE1 pertussis vaccine and Boostrix
Other interventions - Placebo and Boostrix

Experimental: BPZE1 intranasal and Placebo intramuscular - Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.

Experimental: BPZE1 intranasal and Boostrix intramuscular - Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis [aP] vaccine).

Active Comparator: Placebo intranasal and Boostrix intramuscular - Individual will receive an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).


Other interventions: BPZE1 pertussis vaccine and placebo
Live attenuated pertussis vaccine and placebo

Other interventions: BPZE1 pertussis vaccine and Boostrix
Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine

Other interventions: Placebo and Boostrix
Tetanus, diphtheria, and aP vaccine and placebo
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA
Timepoint [1] 0 0
Day 29
Primary outcome [2] 0 0
Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA
Timepoint [2] 0 0
Day 29
Primary outcome [3] 0 0
Immunogenicity Serum IgG: proportion of subjects with antibody concentration =0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens
Timepoint [3] 0 0
Day 29
Primary outcome [4] 0 0
Colonization (substudy only)
Timepoint [4] 0 0
Day 92 or Day 99.
Primary outcome [5] 0 0
Safety: Solicited Adverse Events (AEs)
Timepoint [5] 0 0
Through 7 days following first study vaccination.
Secondary outcome [1] 0 0
Mucosal Immunogenicity S-IgA
Timepoint [1] 0 0
Day 29, Day 85, Day 169 (EOS).
Secondary outcome [2] 0 0
Mucosal Immunogenicity S-IgA
Timepoint [2] 0 0
Day 29, Day 85, Day 169 (EOS).
Secondary outcome [3] 0 0
Serum Immunogenicity S-IgA and IgG
Timepoint [3] 0 0
Baseline, Day 29, Day 85, Day 169 (EOS).
Secondary outcome [4] 0 0
Serum Immunogenicity S-IgA and IgG
Timepoint [4] 0 0
Baseline, Day 29, Day 85, Day 169 (EOS).
Secondary outcome [5] 0 0
Safety: Reactogenicity and AEs
Timepoint [5] 0 0
Through 7 days, 28 days, and 169 days (EOS) following any study vaccination.

Eligibility
Key inclusion criteria
Key

1. Male or female subject 6 to 17 years of age on Day 1.

2. Subject must provide informed consent (assent, depending on age) prior to
participation in study and comply with protocol requirements.

3. If female, the subject is not pregnant or lactating. If female of childbearing
potential, the subject must agree to either be heterosexually inactive or follow birth
control methods per protocol from at least 21 days prior to enrollment and through 90
days following any study vaccination.

4. Subject has a stable health status, as established by physical examination, vital sign
measurements, and medical history.

5. Subject (and/or legal guardian) has access to a consistent and reliable means of
electronic or telephone contact, which may be in the home, workplace, school, or by
personal mobile electronic device.

6. Subject is willing to refrain from routine nasal sprays (including steroid sprays) or
washes for at least 7 days following any study vaccination.

Key
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of pertussis-containing vaccination or documented pertussis infection within 3
years prior to Day 1 and/or a history of Td-containing vaccination (without pertussis
component) within 1 month prior to Day 1.

2. Chronic significant illness actively being treated or a history of recent intervention
for worsening or fluctuating symptoms (at the discretion of the investigator).

3. History of cancer (malignancy).

4. Congenital, hereditary, or acquired disease or disorder classified as autoimmune,
immunodeficient, coagulopathy, hepatic, renal, neurologic, or cognitive.

5. Currently uses smoking products (including vaping and e-cigarettes) and is unwilling
to refrain from use from Day 1 through Day 29 following study vaccination.

6. Subject received immunoglobulin, blood-derived products, systemic corticosteroids (at
a dose of >10 mg per day for more than 10 days), or other immunosuppressant drugs
within 90 days of Day 1.

7. Chronic pulmonary disease requiring active medication or pulmonary therapies except
exercise-induced bronchospasm, if currently well controlled, and willing to refrain
from intense exercise for 7 days following study vaccination, or intermittent asthma
classification who have not had an exacerbation requiring oral systemic
corticosteroids in the past year; have an forced expiratory volume (FEV1) documented
to be >80%; do not have restrictions in normal activity due to breathing issues; and
have used a short-acting beta-agonist less than or equal to 2 days per week over the
past 2 months.

8. History of oro/nasopharynx surgery (eg, adenoidectomy, tonsillectomy) within 60 days
prior to Day 1.

9. Known hypersensitivity to latex or any component of any study vaccine. Specific to
Boostrix: hypersensitivity to neomycin or polymyxin; hypersensitivity after previous
administration of diphtheria, tetanus, or pertussis vaccines; or has experienced
transient thrombocytopenia or neurological complications following an earlier
immunization against diphtheria and/or tetanus.

10. Subject has routine and/or repeated contact with, or is currently living in a
household with, an immunocompromised individual.

11. Subject resides in a residence where an infant less than 6 months of age resides or
may reside.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Sydney Children's Hospital - Westmead
Recruitment hospital [3] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [4] 0 0
University of Melbourne - Melbourne
Recruitment hospital [5] 0 0
Telethon Kids Institute - Nedlands
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- North Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Costa Rica
State/province [1] 0 0
San José
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Birmingham
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Bradford
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Bristol
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Cambridge
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Leicester
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Oxford
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ILiAD Biotechnologies
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis
vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares
BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a
multi-center, randomized, placebo- and active-comparator-controlled study in healthy,
school-age children with a 6-month safety follow-up after the first vaccination.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05116241
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries