Immunogenicity and Safety of Pneumococcal Conjugated Vaccine 13 (PCV13) in Patients With Multiple Myeloma
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Immunogenicity to serotype 6B, 14, 23F, 19F
研究概览
简要总结
Multiple myeloma patients often get serious infections that can be deadly. A British study looked at newly diagnosed patients and found that bacterial infections were the main cause of death in the first 60 days, mostly from pneumonia (66%) and blood poisoning (23%). The most common bacteria causing these infections were pneumococcus, staph, and E. coli.
Medical experts recommend that multiple myeloma patients get pneumonia vaccines. However, some studies show these vaccines don't work well in these patients, raising questions about whether they're really helpful. It's also unclear if patients need one shot or multiple shots like other high-risk patients.
This study at National Taiwan University Hospital will randomly give multiple myeloma patients either one or two doses of the 13-valent pneumonia vaccine. Researchers will check if the vaccine is safe and if it helps the immune system fight infections, while trying to figure out what makes the vaccine work better in some patients than others.
详细描述
Infection has always been a common and potentially life-threatening problem for multiple myeloma patients. A British study on newly diagnosed multiple myeloma patients investigated the causes of death within 60 days of enrollment and found that bacterial infection was the most common cause of death, followed by kidney failure, myocardial infarction, or stroke. Among patients who died from bacterial infections, 66% died from pneumonia, 23% from sepsis, and 11% from other infections. Among bacterial infection patients with culture results, Streptococcus pneumoniae was the most common pathogen, followed by Staphylococcus aureus and Escherichia coli.
The International Myeloma Working Group recommends that multiple myeloma patients receive pneumococcal vaccination. Some research findings have shown that pneumococcal vaccination in multiple myeloma patients is ineffective or very limited in effectiveness, questioning the recommendation for routine pneumococcal vaccination. Furthermore, it remains unknown whether multiple doses of vaccine are needed, as in hematopoietic stem cell transplant patients.
Therefore, for multiple myeloma patients at National Taiwan University Hospital, this study aims to randomly assign patients to receive either one or two doses of 13-valent pneumococcal conjugate vaccine, evaluate its safety and immune response generation, and identify factors related to vaccine efficacy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma
- •Stable clinical condition to have vaccination at outpatient clinic
排除标准
- •Those who have received pneumococcal vaccine within the past five years
- •Unable to communicate verbally with the subject
- •Subject has an active infection
- •Pregnant women
研究组 & 干预措施
2-dose PCV13
2 doses PCV13 with one month apart
干预措施: 2-dose PCV13 (Biological)
1-dose PCV13
1 dose PCV13
干预措施: 1-dose PCV13 (Biological)
结局指标
主要结局
Immunogenicity to serotype 6B, 14, 23F, 19F
时间窗: before every dose of PCV13, and 4 weeks, every 12 weeks for one year, and every year for 5 years after the last dose of PCV13
次要结局
- Safety of PCV13(within one week after each dose of PCV13)
- invasive pneumococcal diseases(after the last dose of PCV13 for 5 years)
- Mortality(after the last dose of PCV13 for 5 years)
- Pneumonia(after the last dose of PCV13 for 5 years)