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A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

Primary Purpose

HIV Infections, Pneumococcal Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Pneumococcal Vaccine, Polyvalent (23-valent)
Pneumococcal Conjugate Vaccine, Heptavalent
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pneumococcal Infections, Bacterial Vaccines

Eligibility Criteria

2 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Antipyretics for rectal temperature >= 100.4 F. Antiretroviral therapy. Patients must have: HIV positivity. Birth weight at least 1800 g (3.75 lb). Consent and compliance of parent or guardian. NOTE: Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Enrollment in HIV vaccine trials. Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures. Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia. Hypogammaglobulinemia. Concurrent Medication: Excluded: Prophylactic antipyretics. Patients with the following prior conditions are excluded: Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry. Prior Medication: Excluded: Any prior pneumococcal vaccine. Measles vaccine within 1 month prior to study vaccination. Any other routine vaccine within 1 week prior to study vaccination. Any immunosuppressant agent, including prednisone, for more than 6 weeks. Prior Treatment: Excluded: Blood products within 56 days prior to study vaccination.

Sites / Locations

  • Usc La Nichd Crs
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • San Francisco Gen. Hosp.
  • UCSF Pediatric AIDS CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Cook County Hosp.
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Tulane/LSU Maternal/Child 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
  • Children's Hospital of Michigan NICHD CRS
  • UMDNJ - Robert Wood Johnson
  • NJ Med. School CRS
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • NYU Med. Ctr., Dept. of Medicine
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • Texas Children's Hosp. CRS
  • UW School of Medicine - CHRMC
  • 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

Placebo Comparator

Arm Label

1

2

Arm Description

Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine

Patients receiving placebo vaccine

Outcomes

Primary Outcome Measures

Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series

Secondary Outcome Measures

Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Lederle-Praxis Biologicals
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1. Study Identification

Unique Protocol Identification Number
NCT00000829
Brief Title
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
Official Title
A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
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
October 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Lederle-Praxis Biologicals

4. Oversight

5. Study Description

Brief Summary
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Detailed Description
Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein. Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pneumococcal Infections
Keywords
Vaccines, Synthetic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pneumococcal Infections, Bacterial Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving intramuscular heptavalent pneumococcal conjugate vaccine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo vaccine
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Vaccine, Polyvalent (23-valent)
Intervention Description
Administered as an injection at 24 months of age
Intervention Type
Biological
Intervention Name(s)
Pneumococcal Conjugate Vaccine, Heptavalent
Intervention Description
Administered as an injection at 0, 2, 4, and 15 months of age
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered at 0, 2, 4, and 15 months of age
Primary Outcome Measure Information:
Title
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
Time Frame
Throughout study
Title
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo
Time Frame
Prior to 4th vaccination and at 1 month after 4th vaccination
Title
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients
Time Frame
Throughout study
Title
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients
Time Frame
At a time after the 3rd vaccination and at a time after the 4th vaccination
Title
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antipyretics for rectal temperature >= 100.4 F. Antiretroviral therapy. Patients must have: HIV positivity. Birth weight at least 1800 g (3.75 lb). Consent and compliance of parent or guardian. NOTE: Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Enrollment in HIV vaccine trials. Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures. Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia. Hypogammaglobulinemia. Concurrent Medication: Excluded: Prophylactic antipyretics. Patients with the following prior conditions are excluded: Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry. Prior Medication: Excluded: Any prior pneumococcal vaccine. Measles vaccine within 1 month prior to study vaccination. Any other routine vaccine within 1 week prior to study vaccination. Any immunosuppressant agent, including prednisone, for more than 6 weeks. Prior Treatment: Excluded: Blood products within 56 days prior to study vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James King, Jr, M.D.
Organizational Affiliation
University of Maryland, College Park
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sharon Nachman, M.D.
Organizational Affiliation
SUNY at Stony Brook
Official's Role
Study Chair
Facility Information:
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
946091809
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
San Francisco Gen. Hosp.
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
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
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
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
212874933
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071072198
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
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
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
Incarnation Children's Ctr.
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
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

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