The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.
With their immunocompromised status, HIV-infected children are at especially high risk for opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and measles. In PACTG P1024, HIV-infected children taking highly active antiretroviral therapy (HAART) received 2 doses of the pneumococcal conjugate vaccine (PCV), 1 dose of the pneumococcal polysaccharide vaccine (PPV), and booster shots of the hepatitis B vaccine (HBV) and measles, mumps, and rubella vaccine (MMR). Early responses to these vaccinations were favorable, but with declining antibody responses within the 18 months after vaccination. It is unknown if additional booster vaccinations in these children will result in a protective immunologic memory upon re-exposure to these pathogens. This study will determine whether HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years after vaccination in PACTG P1024. Patients will be randomly assigned to receive PCV or PPV at study entry. All eligible patients will also receive HBV and MMR at study entry. Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects. Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations; patients who received MMR at study entry will be contacted again around Day 21. Some patients may be asked to return to the clinic for further evaluation if they experience side effects. There will be study visits at study entry and Days 7 and 28. Medical history, a physical exam, blood collection, and an assessment of HIV-related symptoms will occur at all visits. HAART will not be provided by this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
0.5 mL administered intramuscularly
0.5 mL administered intramuscularly
0.5 mL administered intramuscularly
Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol
Time frame: At study entry
Seropositivity, as determined by antibody levels
Time frame: At study entry and Days 7 and 28
Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory
Time frame: Throughout study
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0.5 mL administered subcutaneously
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States
Usc La Nichd Crs
Alhambra, California, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Chicago Children's CRS
Chicago, Illinois, United States
...and 16 more locations