Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using

Status Completed

Clinical Trial 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.

Clinical Trial 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 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 three months apart. Blood samples are collected before the baseline injection (day zero), 1 day after the second injection (91 days post) and 1 month following the second injection (120 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 90, 120, 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04523246
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	Early Phase 1
Start date	September 1, 2020
Completion date	May 19, 2023

View Details

See also
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	`NCT04480333` - Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831	Phase 1
Recruiting	`NCT04565782` - Corona Virus Infection Among Liver Transplant Recipients
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
Withdrawn	`NCT04386447` - Phase II RCT to Assess Efficacy of Intravenous Administration of Oxytocin in Patients Affected by COVID-19	Phase 2
Completed	`NCT05736926` - Anal Fissure Among Survivors of COVID-19 Virus Infection.
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms