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™)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 15
- 主要终点
- Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject 6 to 17 years of age on Day
- •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.
排除标准
- •The subject has a history of whole-cell pertussis vaccination in lifetime, acellular pertussis-containing vaccination (inclusive of school vaccination programs) within 3 years prior to Day 1, documented B. pertussis infection within 3 years prior to Day 1, or a history of Td-containing vaccination (without pertussis vaccine component) within 1 month prior to Day
- •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
- •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
- •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.
研究组 & 干预措施
BPZE1 intranasal and Placebo intramuscular
Individual will receive an intranasal dose of BPZE1 via the mucosal atomization device and a dose of intramuscular placebo.
干预措施: BPZE1 pertussis vaccine and placebo (Biological)
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).
干预措施: BPZE1 pertussis vaccine and Boostrix (Biological)
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).
干预措施: Placebo and Boostrix (Biological)
结局指标
主要结局
Geometric Mean Fold Rise (GMFR) of Mucosal Immunogenicity S-IgA Against Whole Cell Extract at Day 29
时间窗: Day 29
Geometric mean fold rise (GMFR) of mucosal S-IgA against whole cell extract (WCE) by treatment arm (BPZE1, BPZE1 + Boostrix) at Day 29.
Safety: Solicited Adverse Events (AEs)
时间窗: Through 7 days following first study vaccination.
Solicited AEs (local injection site, nasal/respiratory, and systemic reactogenicity events)
次要结局
- Serum IgG: Proportion of Subjects With Antibody Concentration ≥0.1 Immunogenicity Serum IgG for Diphtheria, Tetanus(Day 29)
- Serum IgG: Geometric Mean Concentration (GMC) Against Acellular Pertussis Antigens(Day 29)
- Mucosal Immunogenicity S-IgA GMR(Baseline, Day 29)
- Mucosal Immunogenicity S-IgA GMFR(Day 29)
- Serum Immunogenicity IgA and IgG GMC(Baseline, Day 29)
- Serum Immunogenicity IgA and IgG GMFR(Baseline, Day 29)
- Safety: Reactogenicity and AEs(Through 7 days, 28 days, and 169 days (EOS) following any study vaccination respectively)
- Colonization (Substudy Only)(Day 92 or Day 99.)