Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
HIV Infection, Rotavirus Infection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Rotavirus, Rotavirus vaccine
Eligibility Criteria
Inclusion Criteria for All Vaccinations:
- Participant was born to an HIV-1-infected mother whose HIV-1 diagnosis was determined by two different tests performed on the same or separate maternal samples obtained before or during pregnancy or during the post-partum period. Acceptable tests are antibodies in serum or saliva, HIV RNA or DNA, or antigen in the blood.
- Presence or absence of HIV RNA or DNA in the blood of the infant
- CD4% documented at screening
- Parent or legal guardian agreed to give written informed consent and was willing to comply with study requirements
- Parents/guardians of each participant stated their willingness to have the child follow the country-specific childhood Expanded Programme on Immunization ("EPI") schedule for concomitant childhood vaccines recommended during the study period
- HIV-infected participants had initiated antiretroviral therapy (ART) before or at the time of administration of the first dose of study vaccine/placebo. Note: It was not acceptable for participants to take a prescription home with them to start ART on the day of vaccination.
Inclusion Criteria for second and third vaccinations:
- Successful administration of first vaccine (for second vaccination) and second vaccine (for third vaccination)
- Participants were less than 32 weeks of age at the time of the third vaccine/placebo dose
Exclusion Criteria for All Vaccinations:
- Concurrent participation in any study of an investigational drug or vaccine, except for studies for prevention of perinatal HIV-1 transmission
- Known allergy to any component of the study vaccine
- Active gastrointestinal illness or fever. Fever was defined as greater than or equal to 38.5º C in accordance with WHO guidelines for administration of childhood vaccines.
- Could not be enrolled from any site at which rotavirus vaccine was available and was being administered
- Any condition, which would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
- Any other condition, situation, or clinically significant finding (other than HIV infection) that, in the investigator's opinion, would interfere with study participation, or interpretation
- Participants with a known history of Severe Combined Immunodeficiency (SCID) or intussusception
Exclusion Criteria for second and third vaccinations:
- Any Grade 4 adverse events believed to be possibly/probably/definitely related to vaccine would disqualify subjects from receiving additional doses. Grade 3 adverse events believed to be possibly/probably related to vaccine had to be demonstrated to have improved to less than Grade 2 prior to receiving the next scheduled dose.
Sites / Locations
- Gaborone CRS
- Molepolole CRS
- Kilimanjaro Christian Medical Center CRS
- George CRS
- Harare Family Care CRS
- Parirenyatwa CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
HIV-uninfected RotaTeq
HIV-uninfected Placebo
HIV-infected RotaTeq
HIV-1 infected Placebo
HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age
HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.
HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age