Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents

Completed · Early Phase 1

Conditions studied: Herpes Zoster, Allergy and Immunology, Corona Virus Infection

In brief

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. We hypothesize that: H1: Shingrix vaccination will elevate acute and trained immunity H2: For 6 months following the first injection, increased levels of acute and trained immunity is associated with less disease, including fewer hospitalizations and deaths associated with flu, pneumonia, and COVID-19.

Key facts

Study ID

NCT04523246

Run by

University of Oklahoma

People needed

217

Starts

2020-09-01

Expected to finish

2023-05-19

Last updated by the study team

2023-11-22

Who can join

Age: 65 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Fran and Earl Ziegler College of Nursing — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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