Status:
COMPLETED
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infection
Rotavirus Infection
Eligibility:
All Genders
2-14 years
Phase:
PHASE2
Brief Summary
Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting for 45% of severe diarrhea disease in both developed and developing countries. Annually, rotavirus causes ap...
Detailed Description
International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1072 was an international Phase II randomized double-blind study to assess the safety and immunogenicity of a live, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00880698
Start Date
December 1 2009
End Date
January 1 2014
Last Update
November 5 2021
Active Locations (6)
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1
Gaborone CRS
Gaborone, Botswana
2
Molepolole CRS
Gaborone, Botswana
3
Kilimanjaro Christian Medical Center CRS
Moshi, Tanzania
4
George CRS
Lusaka, Zambia