Clinical Trials

MainTitle

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

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

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)
ClinicalTrials.gov Identifier
NCT00257127

First received: November 18, 2005
Last updated: November 10, 2014
Last Verified: November 2014
History of Changes
Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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)

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 ]
Secondary Outcome Measures:
  • Seropositivity, as determined by antibody levels [ Time Frame: At study entry and Days 7 and 28 ]
  • Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory [ Time Frame: Throughout study ]

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

Eligibility

Ages Eligible for Study: 6 Years to 23 Years  
Sexes Eligible for Study: All  
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

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
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
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
Nyu Ny Nichd Crs
New York, New York, United States, 10016
Metropolitan Hosp. Ctr.
New York, New York, United States, 10029
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
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
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936

Sponsors and Collaborators

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

Investigators

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

More Information

Additional Information:

Click here for more information about PACTG P1024

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: November 10, 2014  

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

Vaccination

Additional relevant MeSH terms:
HIV Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.