The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- immunogenicity
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.
详细描述
S. pneumoniae is an important cause of severe invasive bacterial disease in human immunodeficiency disease (HIV) infected children. The incidence of pneumococcal bacteremia cases requiring hospitalization among Thai children aged < 5 years had a range of 10.6-28.9 cases per 100,000 persons.[1]
Children infected with HIV have a markedly increased risk for pneumococcal infection compared with those who are not HIV-infected. HIV-infected children had rates of invasive pneumococcal disease (IPD) that were 2.8 and 12.6 times the rate among HIV-negative children aged <5 and <3 years, respectively. Incidence of IPD is 6.1 cases/100 patient-years among HIV-infected children through age 7 years [2]
Recent important strategy in prevention of invasive pneumococcal disease (IPD) is an implementation of pneumococcal conjugate vaccine (PCV), which can induce immunity starting from 2 months of age. In a small study of 5-valent PCV among children < 2 years of age, serotype-specific IgG antibodies (ELISA) response after 3 doses was found to be immunogenic among both groups.[3] The Pediatric AIDS Clinical Trials Group Study 292 show that the immunologic responses to 7- valent PCV were similar for all serotypes among asymptomatic and symptomatic HIV - infected children.[4] The study of quantitative and qualitative antibody responses to 9 - valent PCV in HIV-infected children in South Africa shows similar quantitative antibody responses but poorer qualitative antibody responses to the pneumococcal conjugate vaccine when compared to HIV-negative children.[5].
In Thailand, 7 - valent PCV (Prevnar® ) was available in 2003. It is recommended for young children and highly recommended for high risk children such as HIV-infected children, congenital heart disease or premature infants. However, one of the major obstacles for large scale implementation is cost issue. There is no previous study about immunogenicity, safety or efficacy of 7 - valent PCV in HIV -infected Thai children, the objective of this study is to assess the safety and immunogenicity of a 7 - valent PCV vaccine among HIV - infected compared with HIV - exposed children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV - infected children
- •HIV infected individuals
- •Age between 2 months to 9 years
- •Signed written informed consent
- •HIV - exposed negative children
- •Maternal HIV infection, documented prior to delivery.
- •Age between 2 months to 9 years
- •Signed written informed consent
排除标准
- •Active opportunistic infection
- •History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid
- •Using oral steroid or immunosuppressive drugs
- •Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine
研究组 & 干预措施
1
Receive valent pneumococcal conjugated vaccine in HIV - infected children
干预措施: valent pneumococcal conjugated vaccine (Biological)
2
Receive valent pneumococcal conjugated vaccine in HIV negative children
干预措施: valent pneumococcal conjugated vaccine (Biological)
结局指标
主要结局
immunogenicity
时间窗: 28 days
Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination.
次要结局
- compare serotype(28 days)
- Safety(28 days)