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NCT00955851 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00955851
Other study ID # 010902
Secondary ID
Status Completed
Phase N/A
First received August 7, 2009
Last updated July 29, 2010
Start date June 2009
Est. completion date July 2010

Study information
Verified date August 2009
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Pre and post vaccination titers
Titers will be obtained pre vaccination and 4 weeks post vaccination

Locations
Country Name City State
United States George Washington University Hospital Washington DC District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 5 weeks No
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