Pneumonia Clinical Trial
Official title:
A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine
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 |
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).
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | George Washington University Hospital | Washington DC | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
George Washington University |
United States,
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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