A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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.
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 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 |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013