Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

This study has been completed.
Sponsor:
Collaborators:
Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00706550
First received: June 24, 2008
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
HIV Infections
Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
Biological: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Immunoglobulin G (IgG) Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: October 2008
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
Currently commercially available pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23
Biological: Placebo
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

Biological: (PV) 23-valent pneumococcal polysaccharide vaccine
Currently commercially available pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23
Biological: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706550

Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
Investigators
Principal Investigator: Maria Rodriguez-Barradas, MD Michael E DeBakey VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00706550     History of Changes
Other Study ID Numbers: INDA-002-08S
Study First Received: June 24, 2008
Results First Received: September 26, 2013
Last Updated: March 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
pneumococcal polysaccharide vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2014