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Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
(PV) 23-valent pneumococcal polysaccharide vaccine
Placebo
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring pneumococcal polysaccharide vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV infected
  • CD4 count >200
  • no acute illness
  • no pneumococcal vaccination within 3 years
  • naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months
  • willingness to start antiretroviral treatment as recommended by current guidelines

Exclusion Criteria:

  • prior pneumococcal vaccination within 3 years
  • prior AIDS diagnosis based on opportunistic disease
  • acute illness

Sites / Locations

  • Michael E DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate

Delayed

Arm Description

Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine

Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine

Outcomes

Primary Outcome Measures

Immunoglobulin G (IgG) Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
IgG Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Immunoglobulin M (IgM) Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
IgM Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Opsonophagocytic Killing Activity (OPA)
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.
Opsonophagocytic Killing Activity (OPA)
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2008
Last Updated
March 27, 2014
Sponsor
US Department of Veterans Affairs
Collaborators
Albert Einstein College of Medicine, Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00706550
Brief Title
Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
Official Title
Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Albert Einstein College of Medicine, Montefiore Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Other
Arm Description
Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
Arm Title
Delayed
Arm Type
Other
Arm Description
Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
Intervention Type
Biological
Intervention Name(s)
(PV) 23-valent pneumococcal polysaccharide vaccine
Other Intervention Name(s)
Pneumovax 23
Intervention Description
Currently commercially available pneumococcal polysaccharide vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Immunoglobulin G (IgG) Levels
Description
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
Time Frame
Baseline
Title
IgG Levels
Description
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Time Frame
One-month post-vaccine
Title
Immunoglobulin M (IgM) Levels
Description
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
Time Frame
Baseline
Title
IgM Levels
Description
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Time Frame
One-month post-vaccine
Title
Opsonophagocytic Killing Activity (OPA)
Description
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.
Time Frame
Baseline
Title
Opsonophagocytic Killing Activity (OPA)
Description
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.
Time Frame
One-month post-vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV infected CD4 count >200 no acute illness no pneumococcal vaccination within 3 years naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months willingness to start antiretroviral treatment as recommended by current guidelines Exclusion Criteria: prior pneumococcal vaccination within 3 years prior AIDS diagnosis based on opportunistic disease acute illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Rodriguez-Barradas, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

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