CompletedPhase 2

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

Botswana, Tanzania, Zambia202 participantsStarted 2009-12

Plain-language 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.

Who can participate

Age range2 Weeks – 14 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 st…

What they're measuring

Percentage of Participants Developing New Grade >=3 Adverse Events

Timeframe: From study entry until at least 42 days after third vaccination

Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1.

Timeframe: Prior to first vaccination and at least 14 days after third vaccination

Trial details

NCT IDNCT00880698

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-01

Results submitted2015-06-22

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