Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children
Condition: HIV
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): valent pneumococcal conjugated vaccine
Intervention type(s): Biological
Intervention description(s): Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunogenicity; safety; Pneumococcal conjugate vaccine; HIV infected children; 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