Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Condition: HIV Infections; Hepatitis B; Measles; Pneumococcal Infections; Pertussis
MeSH terms: Infections; Communicable Diseases; Hepatitis B; Whooping Cough; Measles; Pneumococcal Infections; Hepatitis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV)
      followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on
      anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of
      children. This study will also look at the protection provided by childhood vaccination
      against measles, pertussis, and hepatitis B virus.

      Pneumococcal infections are the most common AIDS-related infection in HIV-infected children.
      PCV may help reduce the chances of HIV-infected children getting pneumococcal infections.
      This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected
      children receiving HAART. It will look at whether HIV-infected children are protected by
      childhood vaccines received previously and if more doses are safe and improve protection.
    

Detailed description: 
      Infection by Streptococcus pneumoniae is the most frequent opportunistic infection observed
      in HIV-infected children. PCVs are immunogenic and efficacious in normal children and offer
      hope of reducing pneumococcal infections in HIV-infected children. The degree to which
      children on HAART are protected by prior immunizations and are responsive to new
      immunizations is still largely undefined. This study is designed to answer whether PCV
      immunizations are safe and effective. The immune responses to prior immunizations and
      responsiveness to booster doses of vaccines against measles, pertussis, and hepatitis B virus
      of children on HAART will also be examined. Answers to these questions will determine whether
      these children are likely to be protected against these clinically relevant pathogens and
      whether they should routinely receive booster doses of these vaccines after a period of
      HAART.

      Patients are stratified on the basis of CD4 percentage and age. Patients that previously
      received a primary hepatitis B vaccine (HBV) series receive an HBV immunization at entry.
      Other vaccinations may be given (based on age and/or CD4 cell measurement, and immunization
      status) for PCV at entry and 2 months, and measles-mumps-rubella (MMR) vaccine and PPV at 4
      months. Some patients may be administered DTaP at a 6-month visit on the basis of age,
      previous immunization history, and negative tetanus antibody status. Follow-up visits are
      done at 8, 12, and 24 months. Blood samples are collected at all clinic visits for assessment
      of HIV RNA, immune responses against pneumococcus, measles, pertussis, and hepatitis B virus,
      as well as for laboratory evaluations.
    

Intervention name(s): Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed; Measles-Mumps-Rubella Vaccine (Live); Pneumococcal Vaccine, Polyvalent (23-valent); Pneumococcal Conjugate Vaccine, Heptavalent; Hepatitis B Vaccine (Recombinant)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Primary purpose: Prevention
Keywords: Measles-Mumps-Rubella Vaccine; Antibodies, Viral; Hepatitis B Vaccines; Immunization, Secondary; Pneumococcal Vaccines; Antiretroviral Therapy, Highly Active; Diphtheria-Tetanus-acellular Pertussis Vaccines