Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,195
- 试验地点
- 6
- 主要终点
- Seroconversion rates (A/H1N1, A/H3N2, and B)
研究概览
简要总结
Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident that the likelihood of immune interference (in response to conjugated- or co-administered antigens) increases in proportional to the number of glyco-conjugates (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins: tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity, but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13 co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat reduced compared to the results with PCV13 alone.
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. PCV13 has limited co-administration information for adjuvanted influenza vaccine.
This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.
详细描述
This study is a multi-centered, randomized controlled clinical trial: Korea University Guro Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and Catholic University Medical College, St. Vincent's Hospital.
The primary objective is to evaluate the immunogenicity of Fluad after concomitant administration of Fluad and PCV13 in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of sero-conversion rate after Fluad vaccination: Fluad-PCV13 co-administration group versus Fluad alone group
The secondary objective is to evaluate the immunogenicity of PCV13 after concomitant administration in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of PCV13 when co-administered with Fluad compared with PCV13 alone.
This study is also designed to evaluate the safety of concomitant PCV13-Fluad administration in adults aged 60 years or more. All the participants will be followed for the duration of an expected average of 4 weeks after 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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥60 years who signed the informed consent
排除标准
- •Previous pneumococcal vaccine recipients
- •Egg allergy
- •History of serious adverse event after vaccination,
- •any acute disease or infection
- •History of neurological symptoms or signs
- •Impairment of immune function or immunosuppressant use
- •Bleeding diathesis
- •Fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
研究组 & 干预措施
PCV13 and Fluad
437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0
干预措施: Fluad and Prevenar13 (Biological)
Fluad alone
437 Fluad recipients: one vaccine injection administered on Day 0
干预措施: Fluad (Biological)
结局指标
主要结局
Seroconversion rates (A/H1N1, A/H3N2, and B)
时间窗: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)
a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of \<1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
次要结局
- Seroprotection rates and GMT folds (A/H1N1, A/H3N2, and B)(Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).)
- Opsonophagocytic assay (OPA) titers for PCV13(Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).)
研究者
Hee Jin Cheong
Professor
Korea University Guro Hospital