RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-10
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04944095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female subjects of age 55 and above
  2. * Has given voluntary, written, informed consent to participate in the study
  1. * Individuals who are unable to give informed consent.

Contacts and Locations

Study Contact

Sidney J Stohs, Ph.D.
CONTACT
1-214-215-6655
sid.stohs9@gmail.com; sid.stohs@bostonbiopharm.com
William Kraemer, Ph.D.
CONTACT
1-860-208-5189
kraemer@osu.edu

Principal Investigator

Harry G Preuss, MD
STUDY_DIRECTOR
Georgetown University, washington, DC
Robert U Newton, Ph.D.
STUDY_DIRECTOR
Edith Cowan University, Perth Western Australia

Study Locations (Sites)

Southlake Diagnostics, Inc.
Southlake, Texas, 76092
United States

Collaborators and Investigators

Sponsor: Dr. Sidney J. Stohs

  • Harry G Preuss, MD, STUDY_DIRECTOR, Georgetown University, washington, DC
  • Robert U Newton, Ph.D., STUDY_DIRECTOR, Edith Cowan University, Perth Western Australia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-10
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-08-10
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Covid-19
  • Subjects Vaccinated Against Covid-19