Clinical Trials


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

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: March 31, 2001
Last updated: November 25, 2013
Last Verified: November 2013
History of Changes


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
Pneumococcal Infections

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: Primary Purpose: 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)

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

Enrollment: 300
Study Completion Date: November 2004

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.



Ages Eligible for Study: 2 Years to 18 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00013871


United States, Alabama
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
United States, California
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
San Francisco, California, United States, 94143
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Med. Ctr.
Hartford, Connecticut, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS
Washington, District of Columbia, United States
United States, Florida
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, 32610
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
United States, Georgia
Columbus Regional HealthCare System, The Med. Ctr.
Columbus, Georgia, United States, 31901
United States, Illinois
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60614
Chicago Children's CRS
Chicago, Illinois, United States, 60637
United States, Maryland
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 21287
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01655
United States, New Jersey
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hosp. IMPAACT CRS
Bronx, New York, United States, 10457
Montefiore Med. Ctr. - AECOM
Bronx, New York, United States, 19461
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Nyu Ny Nichd Crs
New York, New York, United States, 10016
New York, New York, United States, 10032
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
New York, New York, United States
Metropolitan Hosp. Ctr.
New York, New York, United States
St. Luke's-Roosevelt Hosp. Ctr.
New York, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11794
United States, Pennsylvania
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
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, Puerto Rico

Sponsors and Collaborators

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


Study Chair: Mark Abzug
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00013871   History of Changes  
Other Study ID Numbers: P1024  
  PACTG 1024  
  ACTG P1024  
Study First Received: March 31, 2001  
Last Updated: November 25, 2013  

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:
Communicable Diseases
Whooping Cough
Pneumococcal Infections
Hepatitis B
Heptavalent Pneumococcal Conjugate Vaccine processed this data on March 27, 2020
This information is provided by