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

NCT00955851 | Completed

• 1 other identifier: 010902
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Pneumonia

Outcome Measures

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.

  5 weeks

Study Arms (1)

Pneumonia patients

The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol.

Other: Pre and post vaccination titers

Interventions

Pre and post vaccination titers OTHER

Titers will be obtained pre vaccination and 4 weeks post vaccination

Pneumonia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have been admitted to the Medicine Ward under the Pneumonia Core Measure Protocol as stated by the Joint Commission, and who receive the polyvalent pneumococcal vaccine as an inpatient as indicated by ACIP guidelines.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Hospital

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

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Lead

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 30, 2010

Record last verified: 2009-08

Locations

US (1)