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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05116241
Recruitment Status : Active, not recruiting
First Posted : November 10, 2021
Last Update Posted : December 1, 2023
Sponsor:
Information provided by (Responsible Party):
ILiAD Biotechnologies

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.

Condition or disease Intervention/treatment Phase
Bordetella Pertussis, Whooping Cough Biological: BPZE1 pertussis vaccine and placebo Biological: BPZE1 pertussis vaccine and Boostrix Biological: Placebo and Boostrix Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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™)
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
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.
Biological: BPZE1 pertussis vaccine and placebo
Live attenuated pertussis vaccine and 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).
Biological: BPZE1 pertussis vaccine and Boostrix
Live attenuated pertussis vaccine and tetanus, diphtheria, and 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).
Biological: Placebo and Boostrix
Tetanus, diphtheria, and aP vaccine and placebo




Primary Outcome Measures :
  1. Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA [ Time Frame: Day 29 ]
    Geometric mean titer (GMT) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).

  2. Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA [ Time Frame: Day 29 ]
    Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix, Boostrix control).

  3. Immunogenicity Serum IgG: proportion of subjects with antibody concentration ≥0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens [ Time Frame: Day 29 ]
    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)

  4. Colonization (substudy only) [ Time Frame: Day 92 or Day 99. ]
    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)

  5. Safety: Solicited Adverse Events (AEs) [ Time Frame: Through 7 days following first study vaccination. ]
    Solicited AEs (local, nasal/respiratory, and systemic reactogenicity events)


Secondary Outcome Measures :
  1. Mucosal Immunogenicity S-IgA [ Time Frame: Day 29, Day 85, Day 169 (EOS). ]
    Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMT

  2. Mucosal Immunogenicity S-IgA [ Time Frame: Day 29, Day 85, Day 169 (EOS). ]
    Induction of S-IgA against WCE, FHA, PRN, and any additional anti-pertussis mucosal antibodies identified during assay development using GMFR

  3. Serum Immunogenicity S-IgA and IgG [ Time Frame: Baseline, Day 29, Day 85, Day 169 (EOS). ]
    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

  4. Serum Immunogenicity S-IgA and IgG [ Time Frame: Baseline, Day 29, Day 85, Day 169 (EOS). ]
    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

  5. Safety: Reactogenicity and AEs [ Time Frame: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116241


Locations
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Australia, New South Wales
Sydney Children's Hospital
Randwick, New South Wales, Australia
Sydney Children's Hospital
Westmead, New South Wales, Australia
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Australia, Victoria
University of Melbourne
Melbourne, Victoria, Australia
Australia, Western Australia
Telethon Kids Institute
Nedlands, Western Australia, Australia
Costa Rica
CSA Clinica San Augustin
San José, Costa Rica
IICIMED Instituto de Investigacion en Ciencias Medicas
San José, Costa Rica
MRI, Metropolitan Research Institute
San José, Costa Rica
United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Bristol Royal Hospital For Children
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Leicester Children's Hospital, Ward 14, Level 4,
Leicester, United Kingdom
St George's Healthcare NHS Trust
London, United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Sponsors and Collaborators
ILiAD Biotechnologies
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Responsible Party: ILiAD Biotechnologies
ClinicalTrials.gov Identifier: NCT05116241    
Other Study ID Numbers: IB-201P
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ILiAD Biotechnologies:
Bordetella pertussis (B. pertussis)
Whooping Cough
BPZE1
Boostrix
Vaccine
Children
Booster
Live attenuated vaccine
Additional relevant MeSH terms:
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Whooping Cough
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs