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

Primary Purpose

HIV Infections, Hepatitis B, Measles

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Measles-Mumps-Rubella Vaccine (Live)
Pneumococcal Vaccine, Polyvalent (23-valent)
Pneumococcal Conjugate Vaccine, Heptavalent
Hepatitis B Vaccine (Recombinant)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Measles-Mumps-Rubella Vaccine, Antibodies, Viral, Hepatitis B Vaccines, Immunization, Secondary, Pneumococcal Vaccines, Antiretroviral Therapy, Highly Active, Diphtheria-Tetanus-acellular Pertussis Vaccines

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB, Dept. of Ped., Div. of Infectious Diseases
  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSD Mother-Child-Adolescent Program CRS
  • UCSF Pediatric AIDS CRS
  • Univ. of Colorado Denver NICHD CRS
  • Connecticut Children's Med. Ctr.
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Children's National Med. Ctr. Washington DC NICHD CRS
  • 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
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Columbus Regional HealthCare System, The Med. Ctr.
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Chicago Children's CRS
  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Rutgers - New Jersey Medical School CRS
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • Montefiore Med. Ctr. - AECOM
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • Schneider Children's Hosp., Div. of Infectious Diseases
  • Nyu Ny Nichd Crs
  • Columbia IMPAACT CRS
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
  • Metropolitan Hosp. Ctr.
  • St. Luke's-Roosevelt Hosp. Ctr.
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • St. Christopher's Hosp. for Children
  • Texas Children's Hosp. CRS
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 31, 2001
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
NCT00013871
Brief Title
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
Official Title
Evaluation of the Immunogenicity of Pneumococcal Conjugate Vaccine and Routine Pediatric Immunizations 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
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis B, Measles, Pneumococcal Infections, Pertussis
Keywords
Measles-Mumps-Rubella Vaccine, Antibodies, Viral, Hepatitis B Vaccines, Immunization, Secondary, Pneumococcal Vaccines, Antiretroviral Therapy, Highly Active, Diphtheria-Tetanus-acellular Pertussis Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
Intervention Type
Biological
Intervention Name(s)
Measles-Mumps-Rubella Vaccine (Live)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine, Polyvalent (23-valent)
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Conjugate Vaccine, Heptavalent
Intervention Type
Biological
Intervention Name(s)
Hepatitis B Vaccine (Recombinant)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Abzug
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
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
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
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Connecticut Children's Med. Ctr.
City
Hartford
State/Province
Connecticut
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
06504
Country
United States
Facility Name
Children's National Med. Ctr. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
South Florida CDTC Ft Lauderdale NICHD CRS
City
Fort Lauderdale
State/Province
Florida
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
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
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Columbus Regional HealthCare System, The Med. Ctr.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
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
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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
Montefiore Med. Ctr. - AECOM
City
Bronx
State/Province
New York
ZIP/Postal Code
19461
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
Schneider Children's Hosp., Div. of Infectious Diseases
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
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
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
Cornell Univ., Div. of Ped. Infectious Diseases & Immunology
City
New York
State/Province
New York
Country
United States
Facility Name
Metropolitan Hosp. Ctr.
City
New York
State/Province
New York
Country
United States
Facility Name
St. Luke's-Roosevelt Hosp. Ctr.
City
New York
State/Province
New York
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
Country
United States
Facility Name
St. Christopher's Hosp. for Children
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
22693229
Citation
Abzug MJ, Qin M, Levin MJ, Fenton T, Beeler JA, Bellini WJ, Audet S, Sowers SB, Borkowsky W, Nachman SA, Pelton SI, Rosenblatt HM; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity, immunologic memory, and safety following measles revaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2012 Aug 15;206(4):512-22. doi: 10.1093/infdis/jis386. Epub 2012 Jun 12.
Results Reference
derived
PubMed Identifier
19663708
Citation
Abzug MJ, Warshaw M, Rosenblatt HM, Levin MJ, Nachman SA, Pelton SI, Borkowsky W, Fenton T; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 and P1061s Protocol Teams. Immunogenicity and immunologic memory after hepatitis B virus booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. J Infect Dis. 2009 Sep 15;200(6):935-46. doi: 10.1086/605448.
Results Reference
derived
PubMed Identifier
17938165
Citation
Abzug MJ, Song LY, Fenton T, Nachman SA, Levin MJ, Rosenblatt HM, Pelton SI, Borkowsky W, Edwards KM, Peters J; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1024 Protocol Team. Pertussis booster vaccination in HIV-infected children receiving highly active antiretroviral therapy. Pediatrics. 2007 Nov;120(5):e1190-202. doi: 10.1542/peds.2007-0729. Epub 2007 Oct 15.
Results Reference
derived

Learn more about this trial

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

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