Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
NH-Shingrix
1 other identifier
interventional
217
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Sep 2020
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2023
CompletedNovember 22, 2023
November 1, 2023
1.3 years
August 20, 2020
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidenced of active and trained innate immunity
The primary outcome is change in the release of Type I interferon, interferon gamma, interferon associated molecules, and proinflammatory mediators released from monocytes/macrophages and natural killer cells (including gene activation) after receiving 2 injections of the Shingrix vaccine versus normal saline.
Day 91 and 120 (post vaccination)
Secondary Outcomes (1)
Respiratory Disease Severity (6 month)
Days 120 through 180
Study Arms (2)
Shingrix
EXPERIMENTALShingrix Dosage: two .5 ml injections into the deltoid muscle, administered 3 months apart (Day 0 and Day 90).
Normal Saline
PLACEBO COMPARATORSterile Normal Saline Solution, two .5 ml injections into the deltoid muscle, administered 3 months apart (Day 0 and Day 90)
Interventions
The Shingrix vaccine is a subunit vaccine that contains the recombinant varicella zoster virus (VZV) glycoprotein E (gE), adjuvanted with the proprietary Adjuvant System (AS01B). The AS01B Adjuvant system consists of two immune-stimulants, the saponin, Quillaja saponaria Molina, fraction 21 (QS21), and the toll-like receptor 4 (TLR4) agonist, MPL (3-O-desacyl-40-MPL) that enhance the release of interferon gamma (IFNϒ), which in turn stimulates activation and recruitment of blood monocyte-derived and resident lymph node dendritic cells to take up and present gE to cluster of differentiation 4 (CD4+) T cells.
Eligibility Criteria
You may qualify if:
- Meet Centers for Medicare and Medicaid definition for Long term care resident.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oklahomalead
- Oklahoma Medical Research Foundationcollaborator
Study Sites (1)
Fran and Earl Ziegler College of Nursing
Oklahoma City, Oklahoma, 73117, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barbara W. Carlson, RN, Ph.D.
Professor, University of Oklahoma Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinding is done to ensure staff and residents do not modify reports or reporting of COVID symptoms and to minimize other behaviors (such as sleeping, eating habits, physical activity) that may affect their innate immune system. It will also serve to minimize any bias in the processing/analysis of samples and the interpretation of the study results. During the conduct of the study, only three people (the statistician and 2 research nurses who will reconstitute, draw up, and administer the injections) will have knowledge of the group assignments. Participants, the staff at the nursing home, the staff collecting the COVID symptom data, and study investigators are blinded to the subject assignments.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 21, 2020
Study Start
September 1, 2020
Primary Completion
December 30, 2021
Study Completion
May 19, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share