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OpenTrials
Completed

NCT Number: NCT00955851

A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine

Investigators in the Division of Infectious Diseases and the Division of Hospital Medicine of The George Washington University Medical Center are carrying out a study to determine if hospitalized patients receiving the polyvalent pneumococcal vaccine during an acute illness develop an adequate antibody response. The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol, which assigns appropriate patients for vaccination based on the current guidelines from the Advisory Committee on Immunization Practices (ACIP).

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or female patients ages 18 or older
  • Diagnosis of pneumonia requiring hospitalization
  • Admission to the Medicine Ward under the Pneumonia Core Measure protocol
  • Eligible to receive standard of care pneumococcal vaccine by the treating physician
  • Able to receive an injection
  • Able to provide informed consent

Exclusion criteria

  • Preexisting history of immunosuppression, to include any of the following: HIV/AIDS, Chronic corticosteroid use, Malignancy requiring myeloablative chemotherapy, Hematologic malignancy, History of solid organ or stem cell transplant
  • Pregnancy
  • Receipt of pneumococcal vaccine within the last 5 years
  • Prior history of hypersensitivity reaction to the vaccine
  • Unable to return for follow-up testing

Treatment and study plan

Pre and post vaccination titers

Other

Titers will be obtained pre vaccination and 4 weeks post vaccination

Primary outcomes

  1. A change in the pre- and post-vaccination pneumococcal serotype-specific IgG concentration from baseline will be considered protective based on the laboratory reference range.

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2009
Registry last updated
Jul 30, 2010

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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