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

Completed

• Conditions: Pneumonia
• Interventions: Other: Pre and post vaccination titers

• Registration Number: NCT00955851
• Lead Sponsor: George Washington University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-08
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pneumonia patients	Pre and post vaccination titers	The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

George Washington University Hospital; 🇺🇸 Washington DC, District of Columbia, United States