Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers

• Safety as assessed by all laboratory values (hematologic and chemistry) or signs or symptoms (adverse events) at least Grade 3 not present before the administration of the first vaccination and occurring until the subject goes off study [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  
• Immunogenicity of of RotaTeq as measured by serum anti-rotavirus IgA ELISA SNA responses to type-specific outer surface proteins of the vaccine virus [ Time Frame: At least 14 days after third vaccination ] [ Designated as safety issue: No ]
  

• Fecal shedding of RotaTeq strains [ Time Frame: At entry and on days 7, 14, 21 and 42 days after the first dose, and at days 7 and 21 after the next two doses ] [ Designated as safety issue: No ]
  
• Presence of rotavirus in stool samples resulting from acute gastroenteritis as assessed by EIA, testing for infectious virus and RT-PCR [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• HIV RNA or DNA [ Time Frame: At entry and the last determination at the end of the study ] [ Designated as safety issue: No ]
  
• CD4 count and CD4% [ Time Frame: At entry and the last determination at the end of the study ] [ Designated as safety issue: No ]
  
• Safety for HIV-1 uninfected participants [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  
• Acquisition of HIV-1 infection by participants classified at screening or entry as HIV-1 uninfected [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

Annually, rotavirus causes approximately 111 million episodes of gastroenteritis requiring home care, 25 million clinic visits, 2 million hospitalizations, and approximately 440,000 deaths in children less than 5 years of age, of which approximately 90% of hospitalizations and 99% of deaths occur in developing countries. The primary purpose of this study is to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.

This study will last up to 18 weeks. Participants will be placed in either Group 1 or 2 and subsequently randomized to receive vaccine or placebo.

Participants in Group 1 will be HIV-uninfected. Participants in Arm 1-Vaccine will receive 3 doses of the study vaccine over a 12-week period. Participants in Arm 1-Placebo will receive 3 doses of study vaccine placebo over a 12-week period.

Participants in Group 2 will be HIV-infected. Participants in Arm 2a will have CD4 percentages of at least 20% and will receive 3 doses of the study vaccine (Arm 2a-Vaccine) or the study vaccine placebo (Arm 2a-Placebo) over a 12-week period. Participants in Arm 2b will have CD4 percentages of at least 15% and up to, but not including, 20%, and receive either 3 doses of study vaccine (Arm 2b-Vaccine) or study vaccine placebo (Arm 2b-Placebo) over a 12-week period. Participants in Arm 2c will have CD4 percentages less than 15% and receive either 3 doses of the study vaccine (Arm 2c-Vaccine) or study vaccine placebo (Arm 2c-Placebo) over a 12-week period.

There will be 16 study visits for each participant. They will occur at screening and Days 0, 7, 14, 21, 42, 49, 56, 63, 70, 91, 98, 105, 112, 119, and 140. Study vaccinations will occur on Days 0, 49, and 98. At all visits, participants will undergo a physical examination and will give a directed medical history. At most visits, stool samples will be collected, and additional testing for other potential pathogens may be conducted. Blood collection will occur at select visits. Blood and stool collected at study visits may be stored and used for future HIV-related research.

For any missed visits, study staff will contact participants' caregivers and conduct a study visit at the participant's home, if possible.

If a national recommendation for rotavirus vaccine is implemented at a study site, participants who are receiving the placebo vaccine will be discontinued from the study and will receive the rotavirus vaccine, per site procedures.