Phase 2
N=202
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
HIV Infection · Rotavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT00880698 ↗Enrolled (actual)
202
Serious AEs
7.4%
Results posted
Jul 2015
Primary outcome: Primary: Percentage of Participants Developing New Grade >=3 Adverse Events — 1.6; 4.7; 13.5; 12.8 Percentage of participants — p=0.62
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RotaTeq (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Developing New Grade >=3 Adverse Events |
1.6; 4.7; 13.5; 12.8 | 0.62 |
| PRIMARY 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. |
31.6; 1.7; 52.9; 3.1; 12.3; 5.2 | <0.001 sig |
| SECONDARY Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml |
54.3; 44.1 | — |
| SECONDARY Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants |
3; 3 | — |
| SECONDARY Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants |
201; 335 | — |
| SECONDARY Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00880698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.