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Trial record 10 of 11 for:    "Rubella" | "Heptavalent Pneumococcal Conjugate Vaccine"

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

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ClinicalTrials.gov Identifier: NCT00013871
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 26, 2013
Sponsor:
Collaborator:
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)

Tracking Information
First Submitted Date  ICMJE March 31, 2001
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00013871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Official Title  ICMJE Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Hepatitis B
  • Measles
  • Pneumococcal Infections
  • Pertussis
Intervention  ICMJE
  • 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 Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00013871
Other Study ID Numbers  ICMJE P1024
PACTG 1024
10609 ( Registry Identifier: DAIDS ES Registry Number )
ACTG P1024
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Chair: Mark Abzug
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP