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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00257127
First received: November 18, 2005
Last updated: December 4, 2013
Last verified: December 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)

Resource links provided by NLM:


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
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive PCV, HBV, and MMR at study entry
Biological: Pneumococcal 7-valent conjugate vaccine
0.5 mL administered intramuscularly
Other Name: PCV
Biological: Hepatitis B vaccine
0.5 mL administered intramuscularly
Other Name: HBV
Biological: Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously
Other Name: MMR
Experimental: 2
Patients will receive PPV, HBV, and MMR at study entry
Biological: Pneumococcal polysaccharide vaccine
0.5 mL administered intramuscularly
Other Name: PPV
Biological: Hepatitis B vaccine
0.5 mL administered intramuscularly
Other Name: HBV
Biological: Measles, mumps, and rubella virus vaccine, live
0.5 mL administered subcutaneously
Other Name: MMR

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
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 ClinicalTrials.gov identifier: NCT00257127

Locations
United States, Alabama
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
United States, California
Usc La Nichd Crs
Alhambra, California, United States, 91803
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90806
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, United States, 92103
United States, Colorado
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06510
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States, 33316
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
Gainesville, Florida, United States, 32610-0296
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
United States, Illinois
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
United States, Louisiana
Children's Hosp.
New Orleans, Louisiana, United States, 70118
United States, Massachusetts
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01605
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
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Metropolitan Hosp. Ctr.
New York, New York, United States, 10029
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States, 14642
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794-8111
United States, Pennsylvania
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Investigators
Study Chair: Mark Abzug, MD The Children's Hospital, Denver, CO
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00257127     History of Changes
Other Study ID Numbers: P1061s, 10132, PACTG P1061s
Study First Received: November 18, 2005
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014