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OpenTrials
Completed

NCT Number: NCT00706550

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(PV) 23-valent pneumococcal polysaccharide vaccine

Biological

Currently commercially available pneumococcal polysaccharide vaccine

Other names: Pneumovax 23

Placebo

Biological

Placebo

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Albert Einstein College of Medicine
  • Montefiore Medical Center

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jun 27, 2008
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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