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

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ClinicalTrials.gov Identifier: NCT04523246
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborator:
Oklahoma Medical Research Foundation
Information provided by (Responsible Party):
Barbara Carlson, University of Oklahoma

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.


Condition or disease Intervention/treatment Phase
Herpes Zoster Allergy and Immunology Corona Virus Infection Biological: SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted) Drug: Normal Saline Early Phase 1

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, 2 months apart) with the Shingrix vaccine as compared to placebo (normal saline) in older adults residing in nursing homes. Two hundred nursing home residents, both men and women, aged >65 years, who have not acquired COVID-19 (verified through a screening questionnaire and by both viral antigen and antibody testing at the screen and least one week before the first injection) will get two intramuscular injections containing either the Shingrix vaccine, and the other half, two injections containing a normal saline (placebo comparison) approximately two months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (61 days post) and 1 month following the second injection (90 days). Weekly symptom checks and monthly antibody testing around day 180- will identify residents with COVID-19 and the severity of COVID-19 symptoms.

The primary outcome is the difference in immune cell capacity to produce type I interferon, interferon associated molecules, and proinflammatory mediators after receiving a 2 injection series of the Shingrix vaccine versus normal saline. Secondary outcomes include differences in hospitalization, pulmonary infections, and positive COVID-19 cases (via antibody testing on days 60, 90, and 180) in the Shingrix and normal saline groups. We anticipate that residents receiving the Shingrix vaccine will demonstrate signs of "trained" immunity compared to a control group receiving saline injections.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two hundred nursing home residents, both men and women, aged >65 years, who have not acquired COVID-19 (verified through a screening questionnaire and by both viral antigen and antibody testing at the screen and least one week before the first injection) will get two intramuscular injections containing either the Shingrix vaccine, and the other half, two injections containing a normal saline (comparison) approximately two months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (61 days post) and 1 month following the second injection (90 days). Weekly symptom checks and monthly antibody testing around day 180- will identify residents with COVID-19 and the severity of COVID-19 symptoms.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

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.

Primary Purpose: Basic Science
Official Title: Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents: A Randomized, Doubled-Blinded, Comparative Group Observational Study
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles

Arm Intervention/treatment
Experimental: Shingrix
Shingrix Dosage: two .5 ml injections into the deltoid muscle, administered 2 months apart (Day 0 and Day 60).
Biological: SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)
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 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.

Placebo Comparator: Normal Saline
Sterile Normal Saline Solution, two .5 ml injections into the deltoid muscle, administered 2 months apart (Day 0 and Day 60)
Drug: Normal Saline
Sterile normal saline, inactive control.




Primary Outcome Measures :
  1. Evidenced of active and trained innate immunity [ Time Frame: Day 61 and 90 (post vaccination) ]
    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.


Secondary Outcome Measures :
  1. Respiratory Disease Severity (6 month) [ Time Frame: Days 90 through 180 ]
    cases ( nasal swab for viral antigen and antibody testing), symptoms (symptom checklist), hospitalizations (MDS 3.0 report/chart reviews) and deaths (MDS 3.0 report/chart reviews) associated with flu, pneumonia, and COVID-19.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Meet Centers for Medicare and Medicaid definition for Long term care resident.
  2. 65 years and older.
  3. Have already received or provide consent to receive the 2020 flu vaccine.
  4. Negative screen (within the last 2 weeks) for COVID 19 virus.
  5. Has a history of chickenpox or shingles.
  6. Able to read and speak English.
  7. Able to provide informed consent and assent (with guardian/health care proxy).

Exclusion Criteria:

  1. Brief Interview of Mental Status (BIMS) score <8 (indicating severe dementia).
  2. Prior vaccination with the Shingrix.
  3. Positive test for COVID 19 or prior history of COVID 19 infection.
  4. 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).
  5. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523246


Contacts
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Contact: Barbara W. Carlson, RN, Ph.D. 405-271-1491 ext 49187 Barbara-Carlson@ouhsc.edu
Contact: Diana L Sturdevant, RN, Ph.D. 918-429-8952 Diana-Sturdevant@ouhsc.edu

Locations
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United States, Oklahoma
Fran and Earl Ziegler College of Nursing Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Barbara W. Carlson    405-271-1491    Barbara-Carlson@ouhsc.edu   
Sponsors and Collaborators
Barbara Carlson
Oklahoma Medical Research Foundation
Investigators
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Study Director: Barbara W. Carlson, RN, Ph.D. Professor, University of Oklahoma Health Sciences Center
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Responsible Party: Barbara Carlson, Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT04523246    
Other Study ID Numbers: OUHSC IRB#12394
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Barbara Carlson, University of Oklahoma:
Herpes Zoster
corona virus infection
allergy and immunology
Additional relevant MeSH terms:
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Virus Diseases
Herpes Zoster
Coronavirus Infections
Severe Acute Respiratory Syndrome
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases