Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
Condition: HIV Infection; Rotavirus Infection
MeSH terms: Infections; Communicable Diseases; Rotavirus Infections
Intervention: RotaTeq; Placebo
Intervention description: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose; 2 mL solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 2 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotavirus; Rotavirus vaccine

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 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. Although rotavirus infection is not more common in
      HIV-infected children, it complicates their care and interferes with their nutrition. Chances
      of death by these infections can be greater in HIV-infected children when they also suffer
      from wasting, malnutrition, and/or opportunistic infections. The primary purpose of this
      study was to evaluate the safety and immunogenicity of the Rotavirus vaccine candidate,
      RotaTeq, in HIV-infected and uninfected children born to HIV-infected mothers.
    

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.