Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
4 other identifiers
interventional
300
2 countries
40
Brief Summary
The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in fighting pneumococcal infections in this group of children. This study will also look at the protection provided by childhood vaccination against measles, pertussis, and hepatitis B virus. Pneumococcal infections are the most common AIDS-related infection in HIV-infected children. PCV may help reduce the chances of HIV-infected children getting pneumococcal infections. This study will look at whether pneumococcal vaccines are safe and effective in HIV-infected children receiving HAART. It will look at whether HIV-infected children are protected by childhood vaccines received previously and if more doses are safe and improve protection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
40 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
March 31, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedNovember 1, 2021
October 1, 2021
March 31, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
Usc La Nichd Crs
Los Angeles, California, 90033, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 94609, United States
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103, United States
UCSF Pediatric AIDS CRS
San Francisco, California, 94143, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80218, United States
Connecticut Children's Med. Ctr.
Hartford, Connecticut, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504, United States
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, 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, 32610, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161, United States
Columbus Regional HealthCare System, The Med. Ctr.
Columbus, Georgia, 31901, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60614, United States
Chicago Children's CRS
Chicago, Illinois, 60637, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 21287, 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
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01655, 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
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11040, United States
Nyu Ny Nichd Crs
New York, New York, 10016, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
New York, New York, United States
Metropolitan Hosp. Ctr.
New York, New York, United States
St. Luke's-Roosevelt Hosp. Ctr.
New York, New York, 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, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
Montefiore Med. Ctr. - AECOM
The Bronx, New York, 19461, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
Related Publications (3)
Abzug MJ, Qin M, Levin MJ, Fenton T, Beeler JA, Bellini WJ, Audet S, Sowers SB, Borkowsky W, Nachman SA, Pelton SI, Rosenblatt HM; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity, immunologic memory, and safety following measles revaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2012 Aug 15;206(4):512-22. doi: 10.1093/infdis/jis386. Epub 2012 Jun 12.
PMID: 22693229DERIVEDAbzug MJ, Warshaw M, Rosenblatt HM, Levin MJ, Nachman SA, Pelton SI, Borkowsky W, Fenton T; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity and immunologic memory after hepatitis B virus booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2009 Sep 15;200(6):935-46. doi: 10.1086/605448.
PMID: 19663708DERIVEDAbzug MJ, Song LY, Fenton T, Nachman SA, Levin MJ, Rosenblatt HM, Pelton SI, Borkowsky W, Edwards KM, Peters J; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 Protocol Team. Pertussis booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. Pediatrics. 2007 Nov;120(5):e1190-202. doi: 10.1542/peds.2007-0729. Epub 2007 Oct 15.
PMID: 17938165DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark Abzug