MedTrace Logo

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

NCT04523246 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

  • Herpes Zoster
  • Allergy and Immunology
  • Corona Virus Infection

Interventions

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 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.

DRUG

Normal Saline

Sterile normal saline, inactive control.

Sponsors & Collaborators

  • Oklahoma Medical Research Foundation

    collaborator OTHER

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Barbara W. Carlson, RN, Ph.D. · Professor, University of Oklahoma Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-12-30
Completion
2023-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523246 on ClinicalTrials.gov