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Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

Primary Purpose

Bordetella Pertussis, Whooping Cough

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BPZE1 pertussis vaccine and placebo
BPZE1 pertussis vaccine and Boostrix
Placebo and Boostrix
Sponsored by
ILiAD Biotechnologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bordetella Pertussis, Whooping Cough focused on measuring Bordetella pertussis (B. pertussis), Whooping Cough, BPZE1, Boostrix, Vaccine, Children, Booster, Live attenuated vaccine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  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 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.

Sites / Locations

  • Sydney Children's HospitalRecruiting
  • Sydney Children's HospitalRecruiting
  • Women's and Children's HospitalRecruiting
  • University of MelbourneRecruiting
  • Telethon Kids InstituteRecruiting
  • IICIMED Instituto de Investigacion en Ciencias MedicasRecruiting
  • MRI, Metropolitan Research InstituteRecruiting
  • Birmingham Children's Hospital NHS Foundation Trust
  • Bradford Royal Infirmary
  • Bristol Royal Hospital For Children
  • Addenbrooke's Hospital
  • Leicester Children's Hospital, Ward 14, Level 4,
  • Alder Hey Childrens Hospital
  • St George's Healthcare NHS Trust
  • St Mary's Hospital - PPDS
  • Oxford Vaccine Group
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BPZE1 intranasal and Placebo intramuscular

BPZE1 intranasal and Boostrix intramuscular

Placebo intranasal and Boostrix intramuscular

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA
Geometric mean titer (GMT) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).
Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).
Immunogenicity Serum IgG: proportion of subjects with antibody concentration ≥0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens
Serum IgG levels against diphtheria, tetanus and acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) by treatment groups (BPZE1 + Boostrix vs Boostrix)
Colonization (substudy only)
Proportion of subjects with positive B. pertussis by culture or polymerase chain reaction [PCR]) following re-vaccination/attenuated challenge (BPZE1, BPZE1 + Boostrix, BPZE1 and BPZE1 + Boostrix, Boostrix control)
Safety: Solicited Adverse Events (AEs)
Solicited AEs (local, nasal/respiratory, and systemic reactogenicity events)

Secondary Outcome Measures

Mucosal Immunogenicity S-IgA
Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMT
Mucosal Immunogenicity S-IgA
Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMFR
Serum Immunogenicity S-IgA and IgG
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development using GMT
Serum Immunogenicity S-IgA and IgG
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development using GMFR
Safety: Reactogenicity and AEs
To describe reactogenicity events during the 7 days following any study vaccination, all AEs through 28 days following study vaccination, medically-attended AEs through 84 days following study vaccination, AEs of special interest (AESIs) and serious adverse events (SAE) through Day 169 (EOS), and incidence of severe acute respiratory syndrome-corona virus-2 (SARS-CoV-2) infections or AESIs.

Full Information

First Posted
October 20, 2021
Last Updated
September 6, 2023
Sponsor
ILiAD Biotechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT05116241
Brief Title
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
Official 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™)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ILiAD Biotechnologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This multi-center, randomized, placebo- and active-comparator-controlled study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease. Healthy school-age children will be randomly assigned to 1 of 3 different study treatment groups to receive the intranasal BPZE1 vaccine, the intramuscular Boostrix vaccine, or both. Subjects will first receive the intranasal vaccine (BPZE1 or placebo) using a small, cone-shaped device that attaches to a syringe and sprays the vaccine into the nose. After a 10-minute waiting period, subjects will receive the intramuscular vaccine (Boostrix or placebo) in the upper arm. As this is the first study in school-age children, a staggered enrollment is planned with the first 45 subjects in the older age group of 11-17 years designated as the safety lead-in cohort. After reactogenicity results from the first 7 days after vaccination of the safety lead-in cohort are reviewed by the safety monitoring committee, the remainder of the subjects will be enrolled. Subjects who choose to take part in a small sub-study of revaccination/attenuated challenge will receive BPZE1 intranasal vaccine (open-label) 3 months after the first vaccination. Safety will be monitored for 6 months after the first vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bordetella Pertussis, Whooping Cough
Keywords
Bordetella pertussis (B. pertussis), Whooping Cough, BPZE1, Boostrix, Vaccine, Children, Booster, Live attenuated vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BPZE1 intranasal and Placebo intramuscular
Arm Type
Experimental
Arm Description
Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
Arm Title
BPZE1 intranasal and Boostrix intramuscular
Arm Type
Experimental
Arm Description
Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular Boostrix (acellular pertussis [aP] vaccine).
Arm Title
Placebo intranasal and Boostrix intramuscular
Arm Type
Active Comparator
Arm Description
Individual will receive an intranasal dose of placebo via the mucosal atomization device and a dose of intramuscular Boostrix (aP vaccine comparator).
Intervention Type
Biological
Intervention Name(s)
BPZE1 pertussis vaccine and placebo
Intervention Description
Live attenuated pertussis vaccine and placebo
Intervention Type
Biological
Intervention Name(s)
BPZE1 pertussis vaccine and Boostrix
Intervention Description
Live attenuated pertussis vaccine and tetanus, diphtheria, and aP vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo and Boostrix
Intervention Description
Tetanus, diphtheria, and aP vaccine and placebo
Primary Outcome Measure Information:
Title
Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA
Description
Geometric mean titer (GMT) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).
Time Frame
Day 29
Title
Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA
Description
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).
Time Frame
Day 29
Title
Immunogenicity Serum IgG: proportion of subjects with antibody concentration ≥0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens
Description
Serum IgG levels against diphtheria, tetanus and acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) by treatment groups (BPZE1 + Boostrix vs Boostrix)
Time Frame
Day 29
Title
Colonization (substudy only)
Description
Proportion of subjects with positive B. pertussis by culture or polymerase chain reaction [PCR]) following re-vaccination/attenuated challenge (BPZE1, BPZE1 + Boostrix, BPZE1 and BPZE1 + Boostrix, Boostrix control)
Time Frame
Day 92 or Day 99.
Title
Safety: Solicited Adverse Events (AEs)
Description
Solicited AEs (local, nasal/respiratory, and systemic reactogenicity events)
Time Frame
Through 7 days following first study vaccination.
Secondary Outcome Measure Information:
Title
Mucosal Immunogenicity S-IgA
Description
Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMT
Time Frame
Day 29, Day 85, Day 169 (EOS).
Title
Mucosal Immunogenicity S-IgA
Description
Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMFR
Time Frame
Day 29, Day 85, Day 169 (EOS).
Title
Serum Immunogenicity S-IgA and IgG
Description
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development using GMT
Time Frame
Baseline, Day 29, Day 85, Day 169 (EOS).
Title
Serum Immunogenicity S-IgA and IgG
Description
Induction of serum immunity (IgA and IgG) against WCE, pertussis toxin (PT), FHA, PRN, and any additional anti-pertussis antibodies identified during assay development using GMFR
Time Frame
Baseline, Day 29, Day 85, Day 169 (EOS).
Title
Safety: Reactogenicity and AEs
Description
To describe reactogenicity events during the 7 days following any study vaccination, all AEs through 28 days following study vaccination, medically-attended AEs through 84 days following study vaccination, AEs of special interest (AESIs) and serious adverse events (SAE) through Day 169 (EOS), and incidence of severe acute respiratory syndrome-corona virus-2 (SARS-CoV-2) infections or AESIs.
Time Frame
Through 7 days, 28 days, and 169 days (EOS) following any study vaccination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Male or female subject 6 to 17 years of age on Day 1. Subject must provide informed consent (assent, depending on age) prior to participation in study and comply with protocol requirements. 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. Subject has a stable health status, as established by physical examination, vital sign measurements, and medical history. 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. Subject is willing to refrain from routine nasal sprays (including steroid sprays) or washes for at least 7 days following any study vaccination. Key Exclusion Criteria: 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. Chronic significant illness actively being treated or a history of recent intervention for worsening or fluctuating symptoms (at the discretion of the investigator). History of cancer (malignancy). Congenital, hereditary, or acquired disease or disorder classified as autoimmune, immunodeficient, coagulopathy, hepatic, renal, neurologic, or cognitive. 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. 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. 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. History of oro/nasopharynx surgery (eg, adenoidectomy, tonsillectomy) within 60 days prior to Day 1. 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. Subject has routine and/or repeated contact with, or is currently living in a household with, an immunocompromised individual. Subject resides in a residence where an infant less than 6 months of age resides or may reside.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ILiAD Biotechnologies
Phone
(954) 907-6471
Email
ClinicalTrials@iliadbiotech.com
Facility Information:
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Archana Rajasekharan Nair
Email
Archana.RajasekharanNair@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Brendan McMullan, MBBS, DTMH, PhD, FRACP, FRCPA
Facility Name
Sydney Children's Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Archana Rajasekharan Nair
Email
Archana.RajasekharanNair@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Rama Kandasamy, MBBS, PhD, FRACP
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Martin
Email
donna.martin@adelaide.edu.au
First Name & Middle Initial & Last Name & Degree
Helen Marshall, MD, MPH, MBBS
Facility Name
University of Melbourne
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lani Shields
Email
lani.shiels@unimelb.edu.au
First Name & Middle Initial & Last Name & Degree
Terry Nolan, AO, FAHMS
Facility Name
Telethon Kids Institute
City
Nedlands
State/Province
Western Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Kent
Email
Jennifer.Kent@telethonkids.org.au
First Name & Middle Initial & Last Name & Degree
Peter Richmond, MBBS, MRCP(UK), FRACP
Facility Name
IICIMED Instituto de Investigacion en Ciencias Medicas
City
San José
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berman Siles
Email
silesmb@icimed.cr
First Name & Middle Initial & Last Name & Degree
Lydiana Avila de Benedictis
Facility Name
MRI, Metropolitan Research Institute
City
San José
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Froimzon
Email
mfroimzon@metropolitanocr.com
First Name & Middle Initial & Last Name & Degree
Maricruz Ramírez
Email
mramirez@metropolitanocr.com
First Name & Middle Initial & Last Name & Degree
Gabriela Ivankovich
Facility Name
Birmingham Children's Hospital NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Bradford Royal Infirmary
City
Bradford
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Bristol Royal Hospital For Children
City
Bristol
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Leicester Children's Hospital, Ward 14, Level 4,
City
Leicester
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Alder Hey Childrens Hospital
City
Liverpool
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
St George's Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Completed
Facility Name
St Mary's Hospital - PPDS
City
London
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Oxford Vaccine Group
City
Oxford
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

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