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Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00257127
  Purpose

The purpose of this study is to determine immune system function following vaccination in HIV-infected children currently taking anti-HIV drugs. To test the effectiveness of prior vaccination, patients in this study will receive booster shots of one of two pneumococcal vaccines, a hepatitis B vaccine, and a measles vaccine.


Condition Intervention
HIV Infections
Biological: Pneumococcal 7-valent conjugate vaccine
Biological: Pneumococcal polysaccharide vaccine
Biological: Hepatitis B vaccine
Biological: Measles, mumps, and rubella virus vaccine, live

MedlinePlus related topics:   AIDS    AIDS Medicines    Hepatitis    Hepatitis B    Measles    Memory   

ChemIDplus related topics:   Hepatitis B Vaccines    Heptavalent pneumococcal conjugate vaccine    Pneumococcal Vaccines    Rubella Vaccine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:   Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination 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):

Primary Outcome Measures:
  • Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol [ Time Frame: At study entry ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Seropositivity, as determined by antibody levels [ Time Frame: At study entry and Days 7 and 28 ] [ Designated as safety issue: No ]
  • Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:   101
Study Start Date:   February 2006
Primary Completion Date:   December 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Patients will receive PCV, HBV, and MMR at study entry
Biological: Pneumococcal 7-valent conjugate vaccine
0.5 mL administered intramuscularly
Biological: Hepatitis B vaccine
0.5 mL administered intramuscularly
Biological: Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously
2: Experimental
Patients will receive PPV, HBV, and MMR at study entry
Biological: Pneumococcal polysaccharide vaccine
0.5 mL administered intramuscularly
Biological: Hepatitis B vaccine
0.5 mL administered intramuscularly
Biological: Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously

Detailed Description:

With their immunocompromised status, HIV-infected children are at especially high risk for opportunistic infections, including infection by Streptococcus pneumoniae, hepatitis B, and measles. In PACTG P1024, HIV-infected children taking highly active antiretroviral therapy (HAART) received 2 doses of the pneumococcal conjugate vaccine (PCV), 1 dose of the pneumococcal polysaccharide vaccine (PPV), and booster shots of the hepatitis B vaccine (HBV) and measles, mumps, and rubella vaccine (MMR). Early responses to these vaccinations were favorable, but with declining antibody responses within the 18 months after vaccination. It is unknown if additional booster vaccinations in these children will result in a protective immunologic memory upon re-exposure to these pathogens. This study will determine whether HIV-infected children on HAART have evidence of specific immunologic memory 3 to 4 years after vaccination in PACTG P1024.

Patients will be randomly assigned to receive PCV or PPV at study entry. All eligible patients will also receive HBV and MMR at study entry. Patients will be monitored in the clinic for 1 hour after vaccination for any adverse effects. Study staff will contact patients by phone around Day 3 after study entry to ask patients if they have experienced any adverse effects to the vaccinations; patients who received MMR at study entry will be contacted again around Day 21. Some patients may be asked to return to the clinic for further evaluation if they experience side effects.

There will be study visits at study entry and Days 7 and 28. Medical history, a physical exam, blood collection, and an assessment of HIV-related symptoms will occur at all visits. HAART will not be provided by this study.

  Eligibility
Ages Eligible for Study:   6 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Completed the 96-week initial study period of PACTG P1024 and had enrolled into that study between June 1, 2001 and March 31, 2002
  • Fulfilled PACTG P1024's definition of HAART (taking 3 or more antiretrovirals [ARVs] from at least 2 of the available therapeutic drug classes) during PACTG P1024's vaccination period (Weeks 0 to 24). Patients who were taking 3 nucleoside reverse transcriptase inhibitors during that period without a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (PI) are not eligible for this study. Nontherapeutic boosting doses of ritonavir used in ritonavir-boosted PI regimens are not counted as separate ARVs.
  • Stable ARV regimen in the 4 weeks prior to study entry
  • No changes anticipated to current ARV regimen during this study
  • Willing to complete all study vaccinations and evaluations
  • Willing to use acceptable forms of contraception, if applicable
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Abnormal blood or chemistry values on most recent laboratory tests. More information on this criterion can be found in the protocol.
  • Received PCV, HBV, PPV, or MMR vaccines during PACTG P1024 in a sequence other than specified in PACTG P1024
  • Received one or more doses of each of PCV, PPV, MMR, or HBV vaccines since the end of PACTG P1024's vaccination period
  • Previous Grade 3 or higher adverse events or allergic reactions judged to be possibly or definitely related to the PCV, PPV, MMR, or HBV vaccines
  • Received any killed vaccine within the 4 weeks prior to study entry
  • Received any live vaccine within the 6 weeks prior to study entry
  • Planning to receive any killed or live vaccine other than study vaccines between the first and third study visits
  • Presence of an underlying condition that contraindicates use of any of the study vaccines. Patients who have a CD4% less than 15% will not be given the MMR vaccine, but such patients will not be excluded from this study.
  • Current immunomodulatory therapy, including IL-2, any interferon product, GM-CSF, or thalidomide. Patients taking G-CSF or erythropoietin are not excluded.
  • Anticipated need for immunomodulatory treatment during this study
  • Any intramuscular immune globulin product within the 6 months prior to study entry
  • Intravenous immune globulin within the 11 months prior to study entry
  • Platelets or plasma products within the 7 months prior to study entry
  • Anticipated need for immune globulin products during this study
  • Current systemic immunosuppressive therapy, including the equivalent of 1 mg/kg/day or greater of prednisone in the 2 weeks prior to study entry. Patients using inhaled corticosteroids only are not excluded from this study. More information on this criterion can be found in the protocol.
  • Anticipated need for systemic immunosuppressive therapy during this study
  • Other known or suspected diseases of the immune system
  • Cancer in the 3 months prior to study entry or treatment for cancer within the 3 months prior to study entry
  • Other acute or chronic medical or surgical conditions or contraindications that, in the opinion of the investigator, may interfere with the study
  • Known bleeding disorder
  • Any Grade 2 or higher clinical toxicity at study screening. More information on this criterion can be found in the protocol.
  • Require certain medications
  • Pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257127

Show 30 study locations  Show 30 Study Locations

Sponsors and Collaborators

Investigators
Study Chair:     Mark Abzug, MD     The Children's Hospital, Denver, CO    
  More Information


Click here for more information about PACTG P1024  This link exits the ClinicalTrials.gov site
 
Haga clic aquí para ver información sobre este ensayo clínico en español  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   DAIDS ( Rona Siskind )
Study ID Numbers:   PACTG P1061s
First Received:   November 18, 2005
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00257127
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccination  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Sexually Transmitted Diseases, Viral
Measles
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Hepatitis B
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 10, 2008




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