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Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00706550
First Posted: June 27, 2008
Last Update Posted: April 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Albert Einstein College of Medicine, Inc.
Montefiore Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
June 24, 2008
June 27, 2008
September 26, 2013
December 12, 2013
April 24, 2014
October 2008
September 2011   (Final data collection date for primary outcome measure)
  • Immunoglobulin G (IgG) Levels [ Time Frame: Baseline ]
    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 [ Time Frame: One-month post-vaccine ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: One-month post-vaccine ]
    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) [ Time Frame: Baseline ]
    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) [ Time Frame: One-month post-vaccine ]
    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.
Antibody levels [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00706550 on ClinicalTrials.gov Archive Site
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Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects
Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
HIV Infections
  • Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
    Currently commercially available pneumococcal polysaccharide vaccine
    Other Name: Pneumovax 23
  • Biological: Placebo
    Placebo
  • Immediate

    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

    Interventions:
    • Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
    • Biological: Placebo
  • Delayed

    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

    Interventions:
    • Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
September 2012
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00706550
INDA-002-08S
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
  • Albert Einstein College of Medicine, Inc.
  • Montefiore Medical Center
Principal Investigator: Maria Rodriguez-Barradas, MD Michael E DeBakey VA Medical Center
VA Office of Research and Development
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP