Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
HIV Infections, Hepatitis B, Measles
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Measles-Mumps-Rubella Vaccine, Antibodies, Viral, Hepatitis B Vaccines, Immunization, Secondary, Pneumococcal Vaccines, Antiretroviral Therapy, Highly Active, Diphtheria-Tetanus-acellular Pertussis Vaccines
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are 2 to 18 years of age. Are HIV-infected. Have a viral load (amount of HIV in the blood) under 60,000 copies/ml within 30 days of study entry. Have been on their current anti-HIV drugs for at least 3 months. Have received 4 or more doses of a pertussis vaccine. Have received 1 or more doses of measles vaccine unless a CD4 percent or CD4 number ruled out taking the vaccine. (This reflects a change in the CD4 requirement.) Expect to be able to complete all study injections and follow-up. Have a negative pregnancy test if able to have children and use effective methods of birth control. Have parent or guardian's consent if under 18 years of age. Have received an approved hepatitis B vaccine series. Not required for study entry, but children who have received this vaccine will be studied. (This study was changed to allow patients who became HIV infected after birth, have a viral load between 30,000 and 60,000 copies/ml, and who have been on their current anti-HIV drugs for 3 to 6 months.) Exclusion Criteria Patients will not be eligible for this study if they: Had a certain CD4 level before beginning anti-HIV drugs and at screening. Have received any killed vaccine within 4 weeks, or any live vaccine within 6 weeks, of entering the study. Have received pneumococcal vaccines or had a reaction to PPV. Have had an allergic reaction to any measles or hepatitis B vaccines, or to other routine childhood immunizations if 13 years of age or less. Have any other condition that would make receiving study vaccines inadvisable. Are currently on medications that affect the immune system, except for G-CSF and erythropoietin. This includes the equivalent to more than 1 mg/kg/day of prednisone in the 2 weeks preceding study screening. Nonsteroidal anti-inflammatory agents and inhaled corticosteroids are not excluded. Have received certain blood products within the previous 6 months. Have other diseases of the immune system. Have had cancer within 3 months of study screening or are being treated or have been treated for cancer within 3 months of study entry. Are pregnant. Have any other disease or previous surgery that would interfere with study treatment. Are likely to have bleeding disorders. Show certain side effects to vaccines at screening.
Sites / Locations
- UAB, Dept. of Ped., Div. of Infectious Diseases
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Usc La Nichd Crs
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSD Mother-Child-Adolescent Program CRS
- UCSF Pediatric AIDS CRS
- Univ. of Colorado Denver NICHD CRS
- Connecticut Children's Med. Ctr.
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Children's National Med. Ctr. Washington DC NICHD CRS
- South Florida CDTC Ft Lauderdale NICHD CRS
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Columbus Regional HealthCare System, The Med. Ctr.
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Chicago Children's CRS
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- Rutgers - New Jersey Medical School CRS
- Bronx-Lebanon Hosp. IMPAACT CRS
- Montefiore Med. Ctr. - AECOM
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- Schneider Children's Hosp., Div. of Infectious Diseases
- Nyu Ny Nichd Crs
- Columbia IMPAACT CRS
- Harlem Hosp. Ctr. NY NICHD CRS
- Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
- Metropolitan Hosp. Ctr.
- St. Luke's-Roosevelt Hosp. Ctr.
- Strong Memorial Hospital Rochester NY NICHD CRS
- SUNY Stony Brook NICHD CRS
- St. Christopher's Hosp. for Children
- Texas Children's Hosp. CRS
- San Juan City Hosp. PR NICHD CRS
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS