NCT04523246

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 65 Years – 100 Years
• Healthy volunteers: Accepted

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.

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 ,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.

Conditions

• Herpes Zoster
• Allergy and Immunology
• Corona Virus Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-12-30
• Completion: 2023-05-19
• First posted: 2020-08-21
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study