Change in Antibody Levels Following SARS-CoV-2 (Covid-19) Vaccinations (Covid-19-Abs)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04944095|
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : August 29, 2022
|Condition or disease||Intervention/treatment|
|Covid-19 Subjects Vaccinated Against Covid-19||Other: Change in SARS-CoV-2 Antibody Levels|
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|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|
|Actual Study Start Date :||August 10, 2021|
|Estimated Primary Completion Date :||August 9, 2024|
|Estimated Study Completion Date :||December 31, 2024|
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.
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.
Other Name: No other names apply
- 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) ]Determination of plasma IgG and total (IgG + IgM) antibody levels with time
- Plasma Antibody Levels and Confounding Factors [ Time Frame: Factors affecting changes over 12 months (determinations at baseline, 3,6, 9 and 12 months) ]A determination of whether factors as age, known immunocompetence, use of specific drugs, and specific disease states impact changes in plasma antibody levels over the 12 months of the study.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944095
|Contact: Sidney J Stohs, Ph.D.||email@example.com; firstname.lastname@example.org|
|Contact: William Kraemer, Ph.D.||email@example.com|
|Study Director:||Harry G Preuss, MD||Georgetown University, washington, DC|
|Study Director:||Robert U Newton, Ph.D.||Edith Cowan University, Perth Western Australia|