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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00013871
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 26, 2013
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)

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.

Condition or disease Intervention/treatment Phase
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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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)
Actual Study Completion Date : November 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00013871

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Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Study Chair: Mark Abzug
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00013871    
Other Study ID Numbers: P1024
PACTG 1024
10609 ( Registry Identifier: DAIDS ES Registry Number )
ACTG P1024
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 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:
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Communicable Diseases
Whooping Cough
Pneumococcal Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs