Corona Virus Infection Clinical Trial
— NH-ShingrixOfficial 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
Verified date | November 2023 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 217 |
Est. completion date | May 19, 2023 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 100 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Fran and Earl Ziegler College of Nursing | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | Oklahoma Medical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Respiratory Disease Severity (6 month) | 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. | Days 120 through 180 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT04578210 -
Safety Infusion of NatuRal KillEr celLs or MEmory T Cells as Adoptive Therapy in COVID-19 pnEumonia or Lymphopenia
|
Phase 1/Phase 2 | |
Completed |
NCT05065827 -
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
|
||
Completed |
NCT04720794 -
A Study To Evaluate The Performance of the Lucira Health All-In-One COVID-19 Test Kit vs Hologic Panther Fusion
|
N/A | |
Enrolling by invitation |
NCT04659486 -
Adolescents With COVID-19/MIS-C at HCFMUSP
|
N/A | |
Completed |
NCT04598620 -
Non-invasive Prognostication of COVID-19 Patients by Use of Biomarkers in Exhaled Breath Condensate
|
||
Completed |
NCT05517941 -
Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
|
N/A | |
Recruiting |
NCT04565782 -
Corona Virus Infection Among Liver Transplant Recipients
|
||
Recruiting |
NCT04480333 -
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
|
Phase 1 | |
Active, not recruiting |
NCT04558476 -
Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation
|
Phase 2 | |
Completed |
NCT04526769 -
Detecting SARS-CoV-2 in Tears
|
||
Completed |
NCT05639998 -
BBV152/BBV154 Heterologus Prime-Boost Study
|
Phase 2 | |
Completed |
NCT05736926 -
Anal Fissure Among Survivors of COVID-19 Virus Infection.
|
||
Withdrawn |
NCT04386447 -
Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19
|
Phase 2 | |
Recruiting |
NCT04583566 -
Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients
|
||
Completed |
NCT04643678 -
Anakinra in the Management of COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04579588 -
Understanding Immunity to the Flu Vaccine in COVID-19 Patients
|
||
Terminated |
NCT03331445 -
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
|
Phase 2 | |
Recruiting |
NCT04573348 -
T Cells Response to SARS COV 2 Peptides
|
||
Completed |
NCT04615936 -
Nasal Photodisinfection COVID-19 Proof of Concept Study
|
N/A |