Clinical trial NCT05116241: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bordetella Pertussis, Whooping Cough
Keywords: Bordetella pertussis (B. pertussis)
Whooping Cough
BPZE1
Boostrix
Vaccine
Children
Booster
Live attenuated vaccine
Lead sponsor: ILiAD Biotechnologies
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 367
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Geometric mean titer (GMT) of Mucosal Immunogenicity S-IgA
timeFrame: Day 29
measure: Geometric mean fold rise (GMFR) of Mucosal Immunogenicity S-IgA
timeFrame: Day 29
measure: Immunogenicity Serum IgG: proportion of subjects with antibody concentration ≥0.1 Immunogenicity Serum IgG for diphtheria, tetanus and acellular pertussis antigens
timeFrame: Day 29
measure: Colonization (substudy only)
timeFrame: Day 92 or Day 99.
measure: Safety: Solicited Adverse Events (AEs)
timeFrame: Through 7 days following first study vaccination.
Secondary outcomes:
measure: Mucosal Immunogenicity S-IgA
timeFrame: Day 29, Day 85, Day 169 (EOS).
measure: Mucosal Immunogenicity S-IgA
timeFrame: Day 29, Day 85, Day 169 (EOS).
measure: Serum Immunogenicity S-IgA and IgG
timeFrame: Baseline, Day 29, Day 85, Day 169 (EOS).
measure: Serum Immunogenicity S-IgA and IgG
timeFrame: Baseline, Day 29, Day 85, Day 169 (EOS).
measure: Safety: Reactogenicity and AEs
timeFrame: Through 7 days, 28 days, and 169 days (EOS) following any study vaccination.
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Melbourne
country: Australia
facility: University of Melbourne
state: Victoria
city: Nedlands
country: Australia
facility: Telethon Kids Institute
state: Western Australia
city: San José
country: Costa Rica
facility: CSA Clinica San Augustin
city: San José
country: Costa Rica
facility: IICIMED Instituto de Investigacion en Ciencias Medicas
city: San José
country: Costa Rica
facility: MRI, Metropolitan Research Institute
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital NHS Foundation Trust
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital For Children
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Leicester
country: United Kingdom
facility: Leicester Children's Hospital, Ward 14, Level 4,
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
References: