A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
- Conditions
- HIV InfectionsMeasles
- Interventions
- Biological: AttenuvaxBiological: M-M-R-II
- Registration Number
- NCT00000815
- Brief Summary
To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
- Detailed Description
Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 M-M-R-II Participants who receive vaccination at 6 and 12 months of age 1 Attenuvax Participants who receive vaccination at 6 and 12 months of age 2 M-M-R-II Participants who receive vaccination only at 12 months of age
- Primary Outcome Measures
Name Time Method Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age Throughout study Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children. Throughout study Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age Throughout study
- Secondary Outcome Measures
Name Time Method Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees Throughout study Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age Throughout study Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees Throughout study
Trial Locations
- Locations (46)
NJ Med. School CRS
๐บ๐ธNewark, New Jersey, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
๐บ๐ธBaltimore, Maryland, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
๐บ๐ธAtlanta, Georgia, United States
Usc La Nichd Crs
๐บ๐ธLos Angeles, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
๐บ๐ธLong Beach, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
๐บ๐ธOakland, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
๐บ๐ธLos Angeles, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
๐บ๐ธTorrance, California, United States
Children's National Med. Ctr., ACTU
๐บ๐ธWashington, District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
๐บ๐ธWashington, District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
๐บ๐ธJacksonville, Florida, United States
Cook County Hosp.
๐บ๐ธChicago, Illinois, United States
Chicago Children's CRS
๐บ๐ธChicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
๐บ๐ธChicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
๐บ๐ธChicago, Illinois, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
๐บ๐ธBaltimore, Maryland, United States
Tulane/LSU Maternal/Child CRS
๐บ๐ธNew Orleans, Louisiana, United States
UMDNJ - Robert Wood Johnson
๐บ๐ธNew Brunswick, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey
๐บ๐ธPaterson, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
๐บ๐ธAlbany, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
๐บ๐ธGreat Neck, New York, United States
Schneider Children's Hosp., Div. of Infectious Diseases
๐บ๐ธNew Hyde Park, New York, United States
NYU Med. Ctr., Dept. of Medicine
๐บ๐ธNew York, New York, United States
Metropolitan Hosp. NICHD CRS
๐บ๐ธNew York, New York, United States
Metropolitan Hosp. Ctr.
๐บ๐ธNew York, New York, United States
Columbia IMPAACT CRS
๐บ๐ธNew York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
๐บ๐ธRochester, New York, United States
Incarnation Children's Ctr.
๐บ๐ธNew York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
๐บ๐ธNew York, New York, United States
SUNY Stony Brook NICHD CRS
๐บ๐ธStony Brook, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
๐บ๐ธSyracuse, New York, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
๐บ๐ธPhiladelphia, Pennsylvania, United States
Childrens Hosp. of the Kings Daughters
๐บ๐ธNorfolk, Virginia, United States
Univ. Hosp. Ramรณn Ruiz Arnau, Dept. of Peds.
๐ต๐ทBayamon, Puerto Rico
San Juan City Hosp. PR NICHD CRS
๐ต๐ทSan Juan, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
๐ต๐ทSan Juan, Puerto Rico
UCSD Maternal, Child, and Adolescent HIV CRS
๐บ๐ธSan Diego, California, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
๐บ๐ธBoston, Massachusetts, United States
Texas Children's Hosp. CRS
๐บ๐ธHouston, Texas, United States
UW School of Medicine - CHRMC
๐บ๐ธSeattle, Washington, United States
DUMC Ped. CRS
๐บ๐ธDurham, North Carolina, United States
UAB, Dept. of Ped., Div. of Infectious Diseases
๐บ๐ธBirmingham, Alabama, United States
Univ. of Colorado Denver NICHD CRS
๐บ๐ธAurora, Colorado, United States
Children's Hospital of Michigan NICHD CRS
๐บ๐ธDetroit, Michigan, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
๐บ๐ธNew Haven, Connecticut, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
๐บ๐ธCharleston, South Carolina, United States