Status:
COMPLETED
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Oklahoma Medical Research Foundation
Conditions:
Herpes Zoster
Allergy and Immunology
Eligibility:
All Genders
65-100 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to measure the effect of the Shingrix vaccine on your immune system and whether that has any effect on the body's ability to fight off other infections such as COVID-19. W...
Detailed Description
The purpose of this pilot study is to provide preliminary data in support of the concept that training of the innate immune system occurs following immunization (2 doses ,3 months apart) with the Shin...
Eligibility Criteria
Inclusion
- Meet Centers for Medicare and Medicaid definition for Long term care resident.
- 65 years and older.
- Have already received or provide consent to receive the 2020 flu vaccine.
- Negative screen (within the last 2 weeks) for COVID 19 virus.
- Has a history of chickenpox or shingles.
- Able to read and speak English.
- Able to provide informed consent and assent (with guardian/health care proxy).
Exclusion
- Brief Interview of Mental Status (BIMS) score \<8 (indicating severe dementia).
- Prior vaccination with the Shingrix.
- Positive test for COVID 19 or prior history of COVID 19 infection.
- Conditions that confound the interpretation of the innate immune measures. (i.e. Terminal condition, receiving hospice, Stage 3 and 4 open wound, Chemotherapy, immune modulators or other immunosuppressants, autoimmune disorders, and BMI \< 20 kg/m2).
- Conditions that confound interpretation of respiratory symptoms. (i.e Ventilator dependent, receiving more that 2-3 liters/min of oxygen by nasal cannula, chronic diarrhea, recurrent infections).
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2023
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT04523246
Start Date
September 1 2020
End Date
May 19 2023
Last Update
November 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fran and Earl Ziegler College of Nursing
Oklahoma City, Oklahoma, United States, 73117