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

This study has been completed.
Sponsor:
Information provided by:
George Washington University
ClinicalTrials.gov Identifier:
NCT00955851
First received: August 7, 2009
Last updated: July 29, 2010
Last verified: August 2009
  Purpose

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).


Condition Intervention
Pneumonia
Other: Pre and post vaccination titers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Titers will be obtained pre vaccination and 4 weeks post vaccination

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955851

Locations
United States, District of Columbia
George Washington University Hospital
Washington DC, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
  More Information

No publications provided

Responsible Party: Juan Reyes, MD, George Washington University Medical Faculty Associates
ClinicalTrials.gov Identifier: NCT00955851     History of Changes
Other Study ID Numbers: 010902
Study First Received: August 7, 2009
Last Updated: July 29, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014