A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
研究概览
简要总结
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
详细描述
Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years of age
- •Who have given written informed consent after the nature of the study has been explained.
- •Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.
排除标准
- •The possibility of pregnancy
- •A serious chronic disease including progressive neurological disease or seizure disorder.
- •Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
- •Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
结局指标
主要结局
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
时间窗: one month following the last vaccination
次要结局
未报告次要终点
研究者
Prof. Elizabeth Miller
Prinicipal Investigator
Public Health England