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Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
This study has been completed.
First Received: March 31, 2001   Last Updated: August 6, 2009   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00013871
  Purpose

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.


Condition Intervention
HIV Infections
Hepatitis B
Measles
Pneumococcal Infections
Pertussis
Biological: Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Biological: Measles-Mumps-Rubella Vaccine (Live)
Biological: Pneumococcal Vaccine, Polyvalent (23-valent)
Biological: Pneumococcal Conjugate Vaccine, Heptavalent
Biological: Hepatitis B Vaccine (Recombinant)

Study Type: Interventional
Study Design: Prevention
Official Title: Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 300
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013871

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Univ of California, San Diego
San Diego, California, United States, 92103
Harbor UCLA Med Ctr
Huntington Beach, California, United States, 92646
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Connecticut
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Connecticut Children's Med Ctr
Farmington, Connecticut, United States, 060303805
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Univ of Florida Gainesville
Gainesville, Florida, United States, 32610
United States, Georgia
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
The Med Ctr Inc
Columbus, Georgia, United States, 31901
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
St Joseph's Hosp & Med Center
Paterson, New Jersey, United States, 07503
United States, New York
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Harlem Hosp Ctr
New York, New York, United States, 10037
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
Montefiore Medical / AECOM
Bronx, New York, United States, 19461
United States, Ohio
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
United States, Virginia
Med College of Virginia
Richmond, Virginia, United States, 23219
Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, Puerto Rico, 00956
Sponsors and Collaborators
Investigators
Study Chair: Mark Abzug
  More Information

Additional Information:
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: ACTG P1024, PACTG 1024, DAIDS-ES ID 10609
Study First Received: March 31, 2001
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00013871     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Measles-Mumps-Rubella Vaccine
Antibodies, Viral
Hepatitis B Vaccines
Immunization, Secondary
Pneumococcal Vaccines
Antiretroviral Therapy, Highly Active
Diphtheria-Tetanus-acellular Pertussis Vaccines

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Liver Diseases
Morbillivirus Infections
Slow Virus Diseases
Measles
Hepatitis, Viral, Human
Whooping Cough
Infection
Hepadnaviridae Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Streptococcal Infections
Hepatitis B
Retroviridae Infections
RNA Virus Infections
Paramyxoviridae Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Pneumococcal Infections
Immunologic Deficiency Syndromes
Virus Diseases
Hepatitis
Bordetella Infections
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 30, 2009