Serology Testing (Antibody Levels) With Time Following SARS-CoV-2 (Covid-19) Vaccinations in Residents of Nursing, Extended Care, and Over-55 Communities

Subjects:

This study protocol will be registered with ClinicalTrails.gov and approval by an independent ethics committee. All subjects will be provided detailed written information concerning the trial, and will be required to give written consent to participate in the study. The investigators will collect blood samples from residents associated with over 300 nursing homes, extended care facilities and over-55 communities which have agreed to participate in the study at baseline (when available), and at 3, 6, 9 and 12 month timepoints post-vaccination with one of the three authorized SARS-CoV-2 vaccines. The plasma samples will be analyzed by Southlake Diagnostics.

The study will include up to 10,000 male and female residents of nursing homes, extended care facilities and over-55 communities as well as staff associated with these facilities. Demographic data of the subjects including characteristics, and medical histories including concomitant medications and disease states/conditions will be collected.

Blood Sample Collection:

A standard operating procedure (SOP) has been developed by Southlake Diagnostics to establish a standardized procedure for establishing a safe and appropriate location and method for obtaining human blood samples. This SOP incorporates regulations and recommendations from the Occupational Safety and Health Administration (OSHA) Needlestick Safety and Prevention Act (29 CFR 1910.1030). Blood draws conducted by Southlake Diagnostics personnel will abide by this SOP.