Recruiting

SARS-CoV-2 Vaccination

Sponsor:

Dr. Sidney J. Stohs

Code:

NCT04944095

Conditions

Covid-19

Subjects Vaccinated Against Covid-19

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Change in SARS-CoV-2 Antibody Levels

Study Details

Brief 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

Study ID

NCT04944095

Start date

Aug 10, 2021

Status verified date

Aug, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Aug 9, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female subjects of age 55 and above
  • Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  • Individuals who are unable to give informed consent.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

SARS-CoV-2 Antibody Levels

This is a single arm study by Southlake Diagnostics Inc. whereby changes in plasma antibody levels (IgG and total) are determined over 12 months on individuals residing in over 300 associated nursing homes, extended care facilities and over-55 residences following vaccination with one of the authorized SARS-CoV-2 vaccines (Pfizer, Moderna or J \&J). No interventions are involved. The investigators are not responsible for administering the vaccines or determining subject eligibility or willingness to receive the vaccine. Blood samples will be drawn and plasma IgG and total antibodies will be determined at baseline, 3, 6, 9 and 12 months post-vaccination.

Interventions

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.

Primary outcome measure

  • Changes in Plasma Antibody Levels with Time Following SARS-CoV-2 Vaccinations [ Time Frame: Changes determined over 12 months (at baseline, 3,6, 9 and 12 months) ]

Central Contacts and Locations

Locations

Southlake Diagnostics, Inc.

Recruiting

Southlake, Texas, United States, 76092

Contacts

More Information

Sponsor

Dr. Sidney J. Stohs

Last update posted

Aug 29, 2022

Last verified

Aug, 2022

Keywords

  • IgG antibodies
  • total antibodies (IgG+ IgM)
  • age 55 and above
  • post-covid-19 vaccination
  • Confounding factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr. Sidney J. Stohs on 2022-08-29.