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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pneumococcal 7-valent conjugate vaccine
Pneumococcal polysaccharide vaccine
Hepatitis B vaccine
Measles, mumps, and rubella virus vaccine, live
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Vaccination

Eligibility Criteria

6 Years - 23 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Usc La Nichd Crs
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • UCSD Mother-Child-Adolescent Program CRS
  • Univ. of Colorado Denver NICHD CRS
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • South Florida CDTC Ft Lauderdale NICHD CRS
  • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
  • Univ. of Florida Jacksonville NICHD CRS
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Children's Hosp.
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Rutgers - New Jersey Medical School CRS
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • Nyu Ny Nichd Crs
  • Metropolitan Hosp. Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • St. Christopher's Hosp. for Children
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
  • San Juan City Hosp. PR NICHD CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Patients will receive PCV, HBV, and MMR at study entry

Patients will receive PPV, HBV, and MMR at study entry

Outcomes

Primary Outcome Measures

Grade 3 or greater hematologic and chemistry laboratory values, signs, or symptoms not present, as specified by the protocol

Secondary Outcome Measures

Seropositivity, as determined by antibody levels
Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory

Full Information

First Posted
November 18, 2005
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00257127
Brief Title
Immune System Function Following Vaccination in HIV Infected Children Taking Anti-HIV Drugs
Official Title
Evaluation of Immunologic Memory Following Pneumococcal, Hepatitis B, and Measles Vaccination in HIV Infected Children Treated With Highly Active Antiretroviral Therapy (HAART)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive PCV, HBV, and MMR at study entry
Arm Title
2
Arm Type
Experimental
Arm Description
Patients will receive PPV, HBV, and MMR at study entry
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 7-valent conjugate vaccine
Other Intervention Name(s)
PCV
Intervention Description
0.5 mL administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Pneumococcal polysaccharide vaccine
Other Intervention Name(s)
PPV
Intervention Description
0.5 mL administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine
Other Intervention Name(s)
HBV
Intervention Description
0.5 mL administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Measles, mumps, and rubella virus vaccine, live
Other Intervention Name(s)
MMR
Intervention Description
0.5 mL administered subcutaneously
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Seropositivity, as determined by antibody levels
Time Frame
At study entry and Days 7 and 28
Title
Immunologic memory, as determined by primary and secondary responses, antibody levels, and additional measures of immunologic memory
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Abzug, MD
Organizational Affiliation
The Children's Hospital, Denver, CO
Official's Role
Study Chair
Facility Information:
Facility Name
UAB, Dept. of Ped., Div. of Infectious Diseases
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Usc La Nichd Crs
City
Alhambra
State/Province
California
ZIP/Postal Code
91803
Country
United States
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
UCSD Mother-Child-Adolescent Program CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
South Florida CDTC Ft Lauderdale NICHD CRS
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Children's Hosp.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Rutgers - New Jersey Medical School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Nyu Ny Nichd Crs
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hosp. Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States
Facility Name
St. Christopher's Hosp. for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
15288824
Citation
Obaro SK, Pugatch D, Luzuriaga K. Immunogenicity and efficacy of childhood vaccines in HIV-1-infected children. Lancet Infect Dis. 2004 Aug;4(8):510-8. doi: 10.1016/S1473-3099(04)01106-5.
Results Reference
background
PubMed Identifier
23954381
Citation
Abzug MJ, Song LY, Levin MJ, Nachman SA, Borkowsky W, Pelton SI; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Antibody persistence and immunologic memory after sequential pneumococcal conjugate and polysaccharide vaccination in HIV-infected children on highly active antiretroviral therapy. Vaccine. 2013 Oct 1;31(42):4782-90. doi: 10.1016/j.vaccine.2013.08.002. Epub 2013 Aug 14.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.gov/ct/show/NCT00013871
Description
Click here for more information about PACTG P1024

Learn more about this trial

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

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