Immunogenicity of Pneumococcal Vaccination and Revaccination in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pre and post vaccination (groups I and II) serum samples
研究概览
简要总结
The purpose of this study is to measure how long the improvement in the immune system lasts in older people after they have been vaccinated, and to examine the immune response in older people who get vaccinated a second time.
详细描述
Streptococcus pneumonia is the leading cause of pneumonia the United States, estimated to cause at least 500,000 cases annually and 40,000 deaths. Interest in expanding pneumococcal vaccine administration has arisen with the increased prevalence of antibiotic-resistant S. pneumoniae, increasing numbers of people living with chronic medical conditions, and the aging population.
Extensive studies on vaccine response in older persons have been performed over the past 25 years. However, a number of issues hindered the assessment of vaccine response in older people. Recent studies indicate most healthy older people develop an initial antibody response to vaccination similar to younger cohorts, although antibody response to some serotypes may be less. Limited data suggest functional antibody will develop at least initially after vaccination in older recipients. There are no published reports describing the duration of antibody response or antibody function after revaccination in older patients.
It is difficult to predict the revaccination response and, for those with elevated pre-revaccination antibody, there may be no response to revaccination, or even a lowering of absolute antibody level. Accordingly, a well-controlled revaccination protocol in which older patients with defined vaccine history and known pre-revaccination antibody level are studied for quantitative and qualitative antibody response to revaccination is sorely needed.
The hypotheses for this study are:
- Specific antipneumococcal antibody will remain above prevaccination level in the serum of healthy older people for up to ten years after PPV.
- Healthy older people will have a prompt and robust vaccine response to primary vaccination with PPV.
- The existence of antipneumococcal antibody in healthy older people who had been vaccinated with PPV >5 years previously will not be associated with more pronounced or frequent adverse events or a reduced vaccine response rate.
- The effect of advanced age will account for a reduced vaccine response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in the BLSA with at least 2 stored blood samples post vaccination
- •65 years old or older
- •Previously vaccinated with Pneumovax at least 5 years ago or never vaccinated
- •Willing to receive vaccination with pneumococcal and meningococcal injection
- •Able to provide informed consent
- •Has never received a meningococcal vaccine
排除标准
- •Hypersensitivity to the pneumococcal or meningococcal vaccine
- •Ever received the Meningococcal vaccine
- •History of non-skin cancer
- •History of myeloproliferative disorder
- •History of HIV
- •Received a Bone Marrow Transplant
- •Taking prednisone (more than 5 mg/day) or other immunosuppressive medication
- •Evidence of severe liver or renal disease (serum creatine >2.0 mg/dL or Total Bilirubin >2.0
结局指标
主要结局
Pre and post vaccination (groups I and II) serum samples
时间窗: Day 0, day 28, and 6 months following vaccination and days on each BLSA site visit
次要结局
未报告次要终点