Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
3 other identifiers
interventional
101
2 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Feb 2006
Shorter than P25 for not_applicable hiv-infections
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 1, 2021
October 1, 2021
6 months
November 18, 2005
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol
At study entry
Secondary Outcomes (2)
Seropositivity, as determined by antibody levels
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
Throughout study
Study Arms (2)
1
EXPERIMENTALPatients will receive PCV, HBV, and MMR at study entry
2
EXPERIMENTALPatients will receive PPV, HBV, and MMR at study entry
Interventions
0.5 mL administered intramuscularly
0.5 mL administered subcutaneously
Eligibility Criteria
You may qualify if:
- Completed the 96-week initial study period of PACTG P1024 and had enrolled into that study between June 1, 2001 and March 31, 2002
- 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
You may not qualify if:
- Abnormal blood or chemistry values on most recent laboratory tests. More information on this criterion can be found in the protocol.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233, United States
Usc La Nichd Crs
Alhambra, California, 91803, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90806, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06510, United States
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316, United States
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, 32610-0296, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, United States
Chicago Children's CRS
Chicago, Illinois, 60614, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637, United States
Children's Hosp.
New Orleans, Louisiana, 70118, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01605, United States
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203, United States
Nyu Ny Nichd Crs
New York, New York, 10016, United States
Metropolitan Hosp. Ctr.
New York, New York, 10029, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794-8111, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, 19134, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00935, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Related Publications (2)
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.
PMID: 15288824BACKGROUNDAbzug 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.
PMID: 23954381DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark Abzug, MD
The Children's Hospital, Denver, CO
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
February 1, 2006
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
November 1, 2021
Record last verified: 2021-10