- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00013871
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)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Infection by Streptococcus pneumoniae is the most frequent opportunistic infection observed in HIV-infected children. PCVs are immunogenic and efficacious in normal children and offer hope of reducing pneumococcal infections in HIV-infected children. The degree to which children on HAART are protected by prior immunizations and are responsive to new immunizations is still largely undefined. This study is designed to answer whether PCV immunizations are safe and effective. The immune responses to prior immunizations and responsiveness to booster doses of vaccines against measles, pertussis, and hepatitis B virus of children on HAART will also be examined. Answers to these questions will determine whether these children are likely to be protected against these clinically relevant pathogens and whether they should routinely receive booster doses of these vaccines after a period of HAART.
Patients are stratified on the basis of CD4 percentage and age. Patients that previously received a primary hepatitis B vaccine (HBV) series receive an HBV immunization at entry. Other vaccinations may be given (based on age and/or CD4 cell measurement, and immunization status) for PCV at entry and 2 months, and measles-mumps-rubella (MMR) vaccine and PPV at 4 months. Some patients may be administered DTaP at a 6-month visit on the basis of age, previous immunization history, and negative tetanus antibody status. Follow-up visits are done at 8, 12, and 24 months. Blood samples are collected at all clinic visits for assessment of HIV RNA, immune responses against pneumococcus, measles, pertussis, and hepatitis B virus, as well as for laboratory evaluations.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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San Juan, Puerto Rico
- San Juan City Hosp. PR NICHD CRS
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San Juan, Puerto Rico
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
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Alabama
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Birmingham, Alabama, United States, 35233
- UAB, Dept. of Ped., Div. of Infectious Diseases
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California
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Long Beach, California, United States, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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Los Angeles, California, United States, 90033
- Usc La Nichd Crs
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Oakland, California, United States, 94609
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
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San Diego, California, United States, 92103
- UCSD Mother-Child-Adolescent Program CRS
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San Francisco, California, United States, 94143
- UCSF Pediatric AIDS CRS
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Colorado
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Aurora, Colorado, United States, 80218
- Univ. of Colorado Denver NICHD CRS
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Connecticut
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Hartford, Connecticut, United States
- Connecticut Children's Med. Ctr.
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New Haven, Connecticut, United States, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
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District of Columbia
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Washington, District of Columbia, United States
- Children's National Med. Ctr. Washington DC NICHD CRS
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Florida
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Fort Lauderdale, Florida, United States
- South Florida CDTC Ft Lauderdale NICHD CRS
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Gainesville, Florida, United States, 32610
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
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Jacksonville, Florida, United States, 32209
- Univ. of Florida Jacksonville NICHD CRS
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Miami, Florida, United States, 33161
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
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Georgia
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Columbus, Georgia, United States, 31901
- Columbus Regional HealthCare System, The Med. Ctr.
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Illinois
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Chicago, Illinois, United States, 60614
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
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Chicago, Illinois, United States, 60637
- Chicago Children's CRS
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Maryland
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Baltimore, Maryland, United States, 21201
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
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Massachusetts
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Boston, Massachusetts, United States, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
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Boston, Massachusetts, United States, 02118
- BMC, Div. of Ped Infectious Diseases
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Springfield, Massachusetts, United States, 01199
- Baystate Health, Baystate Med. Ctr.
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Worcester, Massachusetts, United States, 01655
- WNE Maternal Pediatric Adolescent AIDS CRS
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New Jersey
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Newark, New Jersey, United States, 07103
- Rutgers - New Jersey Medical School CRS
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New York
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Bronx, New York, United States, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
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Bronx, New York, United States, 19461
- Montefiore Med. Ctr. - AECOM
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Brooklyn, New York, United States, 11203
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
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New Hyde Park, New York, United States, 11040
- Schneider Children's Hosp., Div. of Infectious Diseases
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New York, New York, United States, 10016
- Nyu Ny Nichd Crs
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New York, New York, United States, 10032
- Columbia IMPAACT CRS
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New York, New York, United States, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
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New York, New York, United States
- Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
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New York, New York, United States
- Metropolitan Hosp. Ctr.
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New York, New York, United States
- St. Luke's-Roosevelt Hosp. Ctr.
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Rochester, New York, United States, 14642
- Strong Memorial Hospital Rochester NY NICHD CRS
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Stony Brook, New York, United States, 11794
- SUNY Stony Brook NICHD CRS
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- St. Christopher's Hosp. for Children
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hosp. CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Mark Abzug
Publications and helpful links
General Publications
- 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.
- Abzug 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.
- Abzug 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.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Infections
- Communicable Diseases
- Hepatitis B
- Whooping Cough
- Measles
- Pneumococcal Infections
- Hepatitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- P1024
- PACTG 1024
- 10609 (DAIDS ES Registry Number)
- ACTG P1024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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