Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

Not Applicable

Completed

• Conditions: Pneumococcal Infections; Pertussis; HIV Infections; Hepatitis B; Measles

• Registration Number: NCT00013871
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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 Timeline

• Study First Submitted: 2001-03-31
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Study Completion: 2004-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (40)

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases; 🇺🇸 Baltimore, Maryland, United States

Univ. of Miami Ped. Perinatal HIV/AIDS CRS; 🇺🇸 Miami, Florida, United States

Usc La Nichd Crs; 🇺🇸 Los Angeles, California, United States

Connecticut Children's Med. Ctr.; 🇺🇸 Hartford, Connecticut, United States

Univ. of Florida Jacksonville NICHD CRS; 🇺🇸 Jacksonville, Florida, United States

Chicago Children's CRS; 🇺🇸 Chicago, Illinois, United States

WNE Maternal Pediatric Adolescent AIDS CRS; 🇺🇸 Worcester, Massachusetts, United States

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS; 🇺🇸 Brooklyn, New York, United States

St. Luke's-Roosevelt Hosp. Ctr.; 🇺🇸 New York, New York, United States

Columbia IMPAACT CRS; 🇺🇸 New York, New York, United States

Harlem Hosp. Ctr. NY NICHD CRS; 🇺🇸 New York, New York, United States

Strong Memorial Hospital Rochester NY NICHD CRS; 🇺🇸 Rochester, New York, United States

SUNY Stony Brook NICHD CRS; 🇺🇸 Stony Brook, New York, United States

St. Christopher's Hosp. for Children; 🇺🇸 Philadelphia, Pennsylvania, United States

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS; 🇵🇷 San Juan, Puerto Rico

UCSF Pediatric AIDS CRS; 🇺🇸 San Francisco, California, United States

Long Beach Memorial Med. Ctr., Miller Children's Hosp.; 🇺🇸 Long Beach, California, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.; 🇺🇸 Oakland, California, United States

UCSD Mother-Child-Adolescent Program CRS; 🇺🇸 San Diego, California, United States

Children's National Med. Ctr. Washington DC NICHD CRS; 🇺🇸 Washington, District of Columbia, United States

South Florida CDTC Ft Lauderdale NICHD CRS; 🇺🇸 Fort Lauderdale, Florida, United States

Columbus Regional HealthCare System, The Med. Ctr.; 🇺🇸 Columbus, Georgia, United States

HMS - Children's Hosp. Boston, Div. of Infectious Diseases; 🇺🇸 Boston, Massachusetts, United States

BMC, Div. of Ped Infectious Diseases; 🇺🇸 Boston, Massachusetts, United States

Rutgers - New Jersey Medical School CRS; 🇺🇸 Newark, New Jersey, United States

Schneider Children's Hosp., Div. of Infectious Diseases; 🇺🇸 New Hyde Park, New York, United States

Nyu Ny Nichd Crs; 🇺🇸 New York, New York, United States

Texas Children's Hosp. CRS; 🇺🇸 Houston, Texas, United States

UAB, Dept. of Ped., Div. of Infectious Diseases; 🇺🇸 Birmingham, Alabama, 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

Univ. of Colorado Denver NICHD CRS; 🇺🇸 Aurora, Colorado, United States

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease; 🇺🇸 Chicago, Illinois, United States

Baystate Health, Baystate Med. Ctr.; 🇺🇸 Springfield, Massachusetts, United States

San Juan City Hosp. PR NICHD CRS; 🇵🇷 San Juan, Puerto Rico

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease; 🇺🇸 New Haven, Connecticut, United States

Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy; 🇺🇸 Gainesville, Florida, United States

Bronx-Lebanon Hosp. IMPAACT CRS; 🇺🇸 Bronx, New York, United States

Montefiore Med. Ctr. - AECOM; 🇺🇸 Bronx, New York, United States