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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00013871
Other study ID # P1024
Secondary ID PACTG 102410609A
Status Completed
Phase N/A
First received
Last updated
Est. completion date November 2004

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design


Intervention

Biological:
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed

Measles-Mumps-Rubella Vaccine (Live)

Pneumococcal Vaccine, Polyvalent (23-valent)

Pneumococcal Conjugate Vaccine, Heptavalent

Hepatitis B Vaccine (Recombinant)


Locations

Country Name City State
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
Puerto Rico Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS San Juan
United States Univ. of Colorado Denver NICHD CRS Aurora Colorado
United States Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases Baltimore Maryland
United States Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology Baltimore Maryland
United States UAB, Dept. of Ped., Div. of Infectious Diseases Birmingham Alabama
United States BMC, Div. of Ped Infectious Diseases Boston Massachusetts
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States Montefiore Med. Ctr. - AECOM Bronx New York
United States SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS Brooklyn New York
United States Chicago Children's CRS Chicago Illinois
United States Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Chicago Illinois
United States Columbus Regional HealthCare System, The Med. Ctr. Columbus Georgia
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
United States Connecticut Children's Med. Ctr. Hartford Connecticut
United States Texas Children's Hosp. CRS Houston Texas
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States Long Beach Memorial Med. Ctr., Miller Children's Hosp. Long Beach California
United States Usc La Nichd Crs Los Angeles California
United States Univ. of Miami Ped. Perinatal HIV/AIDS CRS Miami Florida
United States Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease New Haven Connecticut
United States Schneider Children's Hosp., Div. of Infectious Diseases New Hyde Park New York
United States Columbia IMPAACT CRS New York New York
United States Cornell Univ., Div. of Ped. Infectious Diseases & Immunology New York New York
United States Harlem Hosp. Ctr. NY NICHD CRS New York New York
United States Metropolitan Hosp. Ctr. New York New York
United States Nyu Ny Nichd Crs New York New York
United States St. Luke's-Roosevelt Hosp. Ctr. New York New York
United States Rutgers - New Jersey Medical School CRS Newark New Jersey
United States Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California
United States St. Christopher's Hosp. for Children Philadelphia Pennsylvania
United States Strong Memorial Hospital Rochester NY NICHD CRS Rochester New York
United States UCSD Mother-Child-Adolescent Program CRS San Diego California
United States UCSF Pediatric AIDS CRS San Francisco California
United States Baystate Health, Baystate Med. Ctr. Springfield Massachusetts
United States SUNY Stony Brook NICHD CRS Stony Brook New York
United States Children's National Med. Ctr. Washington DC NICHD CRS Washington District of Columbia
United States WNE Maternal Pediatric Adolescent AIDS CRS Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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