Understanding Poor Vaccine Responses to Hepatitis B Vaccination
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
- Proportion of Participants with Weak Vaccine Response
研究概览
简要总结
Vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. Hepatitis B vaccine nonresponses are common but immunologically not well-understood.
This study aims to study the immunology of hepatitis B vaccine responses by comparing traditional HBV vaccine, which is associated with nonresponses in some patients, to CpG-adjuvanted HBV vaccine, which is associated with far fewer rates of nonresponses. This research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. This information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Must be able to understand and sign the Informed Consent Form (ICF)
排除标准
- •Known chronic HBV infection
- •Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia
- •Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
- •Use of immune-suppressing medications in the 30 days prior to enrollment HIV/AIDS patients will be included in the study as these patients often have poor responses to HBV vaccine.
研究组 & 干预措施
CpG-adjuvanted HBV Vaccine
干预措施: CpG-adjuvanted HBV Vaccine (Biological)
Traditional HBV Vaccine
干预措施: Traditional HBV Vaccine (Biological)
结局指标
主要结局
Proportion of Participants with Weak Vaccine Response
时间窗: Month 1 Post-Final Dose
Weak vaccine response is defined as Hepatitis B surface antigen antibodies \<= 10 mIU/mL (i.e. plasma anti-Hepatitis B surface antibody titer that is undetectable or below the cuff)
次要结局
未报告次要终点