Change in Antibody Levels Following SARS-CoV-2 (Covid-19) Vaccinations

Summary

Limited information is available regarding the effects of various factors that may influence the duration and effectiveness of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccinations. This virus causes Covid-19. Such factors include age, disease states, general immunocompetence, and use of various drugs. The results of this study by Southlake Diagnostics Inc. will provide base-line antibody (IgG and total) data regarding the extent to which the results from this test can be interpreted as an indication or degree of protection from infection after vaccination with one of the three authorized SARS-CoV-2 vaccines (Pfizer, Moderna or J\& J), with information regarding various confounding factors. The study will include 30,000 male and female or more residents associated with over 300 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 and submitted to Southlake Diagnostics for analysis via the REDCap platform (described below). Various possible statistical correlations will be assessed.

Conditions

• Covid-19
• Subjects Vaccinated Against Covid-19

Interventions

OTHER

Change in SARS-CoV-2 Antibody Levels

Changes in plasma antibody levels over 12 months will be determine post-vaccination with one of the authorized SARS-CoV-2 vaccines.

Sponsors & Collaborators

• Telos Healthcare, LLC

  collaborator UNKNOWN

• Remarkable Healthcare

  collaborator UNKNOWN

• The Alden Network

  collaborator UNKNOWN

• Churchill Residential

  collaborator UNKNOWN

• Corridor Mobile Medical Services

  collaborator UNKNOWN

• Siemens Healthineers USA

  collaborator UNKNOWN

• HealthTrackRX/AIT

  collaborator UNKNOWN

• Abri Healthcare Services, LLC

  collaborator UNKNOWN

• Brookdale Senior Living, Inc.

  collaborator UNKNOWN

• Cantex Healthcare Centers, LLC

  collaborator UNKNOWN

• Christian Care Centers, Inc.

  collaborator UNKNOWN

• Cottonwood Creek Healthcare Community

  collaborator UNKNOWN

• Creative Solutions in Healthcare, Inc.

  collaborator UNKNOWN

• Dynasty Healthcare LLC

  collaborator UNKNOWN

• Midlothian Care Center

  collaborator UNKNOWN

• Nexion Health, Inc.

  collaborator UNKNOWN

• Optimum Healthcare, Inc.

  collaborator UNKNOWN

• Paramount Healthcare Consultants, LLC

  collaborator UNKNOWN

• Priority Healthcare, Inc.

  collaborator UNKNOWN

• Revelations Healthcare Group, LLC

  collaborator UNKNOWN

• Southwest Long Term Care, LLC

  collaborator UNKNOWN

• Stonegate Senior Living, LLC

  collaborator UNKNOWN

• Summit Healthcare, Inc.

  collaborator UNKNOWN

• TGR Healthcare, LLC

  collaborator UNKNOWN

• Trinity Healthcare, LLC

  collaborator UNKNOWN

• Dr. Sidney J. Stohs

  lead OTHER

Principal Investigators

• Harry G Preuss, MD · Georgetown University, washington, DC

• Robert U Newton, Ph.D. · Edith Cowan University, Perth Western Australia

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-10

Primary Completion

2024-08-09

Completion

2024-12-31

Countries

• United States

Study Locations