Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
NCT ID: NCT00257127
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2006-02-28
2006-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Patients will receive PCV, HBV, and MMR at study entry
Pneumococcal 7-valent conjugate vaccine
0.5 mL administered intramuscularly
Hepatitis B vaccine
0.5 mL administered intramuscularly
Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously
2
Patients will receive PPV, HBV, and MMR at study entry
Pneumococcal polysaccharide vaccine
0.5 mL administered intramuscularly
Hepatitis B vaccine
0.5 mL administered intramuscularly
Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously
Interventions
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Pneumococcal 7-valent conjugate vaccine
0.5 mL administered intramuscularly
Pneumococcal polysaccharide vaccine
0.5 mL administered intramuscularly
Hepatitis B vaccine
0.5 mL administered intramuscularly
Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fulfilled PACTG P1024's definition of HAART (taking 3 or more antiretrovirals \[ARVs\] from at least 2 of the available therapeutic drug classes) during PACTG P1024's vaccination period (Weeks 0 to 24). Patients who were taking 3 nucleoside reverse transcriptase inhibitors during that period without a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (PI) are not eligible for this study. Nontherapeutic boosting doses of ritonavir used in ritonavir-boosted PI regimens are not counted as separate ARVs.
* Stable ARV regimen in the 4 weeks prior to study entry
* No changes anticipated to current ARV regimen during this study
* Willing to complete all study vaccinations and evaluations
* Willing to use acceptable forms of contraception, if applicable
* Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria
* Received PCV, HBV, PPV, or MMR vaccines during PACTG P1024 in a sequence other than specified in PACTG P1024
* Received one or more doses of each of PCV, PPV, MMR, or HBV vaccines since the end of PACTG P1024's vaccination period
* Previous Grade 3 or higher adverse events or allergic reactions judged to be possibly or definitely related to the PCV, PPV, MMR, or HBV vaccines
* Received any killed vaccine within the 4 weeks prior to study entry
* Received any live vaccine within the 6 weeks prior to study entry
* Planning to receive any killed or live vaccine other than study vaccines between the first and third study visits
* Presence of an underlying condition that contraindicates use of any of the study vaccines. Patients who have a CD4% less than 15% will not be given the MMR vaccine, but such patients will not be excluded from this study.
* Current immunomodulatory therapy, including IL-2, any interferon product, GM-CSF, or thalidomide. Patients taking G-CSF or erythropoietin are not excluded.
* Anticipated need for immunomodulatory treatment during this study
* Any intramuscular immune globulin product within the 6 months prior to study entry
* Intravenous immune globulin within the 11 months prior to study entry
* Platelets or plasma products within the 7 months prior to study entry
* Anticipated need for immune globulin products during this study
* Current systemic immunosuppressive therapy, including the equivalent of 1 mg/kg/day or greater of prednisone in the 2 weeks prior to study entry. Patients using inhaled corticosteroids only are not excluded from this study. More information on this criterion can be found in the protocol.
* Anticipated need for systemic immunosuppressive therapy during this study
* Other known or suspected diseases of the immune system
* Cancer in the 3 months prior to study entry or treatment for cancer within the 3 months prior to study entry
* Other acute or chronic medical or surgical conditions or contraindications that, in the opinion of the investigator, may interfere with the study
* Known bleeding disorder
* Any Grade 2 or higher clinical toxicity at study screening. More information on this criterion can be found in the protocol.
* Require certain medications
* Pregnancy
6 Years
23 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Mark Abzug, MD
Role: STUDY_CHAIR
The Children's Hospital, Denver, CO
Locations
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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
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Children's Hosp.
New Orleans, Louisiana, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
Nyu Ny Nichd Crs
New York, New York, United States
Metropolitan Hosp. Ctr.
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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Obaro SK, Pugatch D, Luzuriaga K. Immunogenicity and efficacy of childhood vaccines in HIV-1-infected children. Lancet Infect Dis. 2004 Aug;4(8):510-8. doi: 10.1016/S1473-3099(04)01106-5.
Abzug MJ, Song LY, Levin MJ, Nachman SA, Borkowsky W, Pelton SI; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Antibody persistence and immunologic memory after sequential pneumococcal conjugate and polysaccharide vaccination in HIV-infected children on highly active antiretroviral therapy. Vaccine. 2013 Oct 1;31(42):4782-90. doi: 10.1016/j.vaccine.2013.08.002. Epub 2013 Aug 14.
Related Links
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Click here for more information about PACTG P1024
Other Identifiers
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10132
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG P1061s
Identifier Type: -
Identifier Source: secondary_id
P1061s
Identifier Type: -
Identifier Source: org_study_id