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| 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) |
| Estimated Enrollment: | 300 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
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 |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Hide Study 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 | |
| Study Chair: | Mark Abzug |
More Information
| 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 |
|
Measles-Mumps-Rubella Vaccine Antibodies, Viral Hepatitis B Vaccines Immunization, Secondary |
Pneumococcal Vaccines Antiretroviral Therapy, Highly Active Diphtheria-Tetanus-acellular Pertussis Vaccines |
|
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 |