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

• ClinicalTrials.gov Identifier: NCT04944095
• Recruitment Status: Recruiting
• First Posted: June 29, 2021
• Last Update Posted: August 29, 2022
• Sponsor: Dr. Sidney J. Stohs
• Collaborators: Telos Healthcare, LLC; Remarkable Healthcare; The Alden Network; Churchill Residential; Corridor Mobile Medical Services; Siemens Healthineers USA; HealthTrackRX/AIT; Abri Healthcare Services, LLC; Brookdale Senior Living, Inc.; Cantex Healthcare Centers, LLC; Christian Care Centers, Inc.; Cottonwood Creek Healthcare Community; Creative Solutions in Healthcare, Inc.; Dynasty Healthcare LLC; Midlothian Care Center; Nexion Health, Inc.; Optimum Healthcare, Inc.; Paramount Healthcare Consultants, LLC; Priority Healthcare, Inc.; Revelations Healthcare Group, LLC; Southwest Long Term Care, LLC; Stonegate Senior Living, LLC; Summit Healthcare, Inc.; TGR Healthcare, LLC; Trinity Healthcare, LLC
• Information provided by (Responsible Party): Dr. Sidney J. Stohs, Boston Biopharm, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Covid-19; Subjects Vaccinated Against Covid-19	Other: Change in SARS-CoV-2 Antibody Levels

Detailed Description:

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.

The OSHA Bloodborne Pathogen Standard, (29 CFR 1910.1030) defines the required usage of Safety Engineered Sharps Devices for any clinical research (including blood draws and injections). All personnel conducting human blood draws are required to use Safety Engineered Sharps Devices.

Personnel conducting blood draws are required to wear the appropriate personal protective equipment (PPE). The Clinical Operations team is responsible for verifying that laboratory personnel performing blood draws have appropriate training and experience in conducting human blood sampling.

Blood samples will be drawn from an appropriate vein as the median cubital vein. Blood samples of 3.0 ml will be collected in BD Vacutainer blood collection tubes containing lithium-heparin using 21-23 gage needles. The blood samples will be packed in biohazard, plastic leak-proof bags, and transported in insulated containers with cold packs to ensure the integrity of the samples, as necessary. Plasma will be prepared by centrifugation. Plasma samples will be stored at 2-8°C if not tested within 8 hours, and frozen if not tested within 14 days.

Analytical Methods:

IgG antibodies to SARS-CoV-2 in human plasma (lithium-heparin) will be determined using the Siemen's Atellica® IM SARS-CoV-2 IgG (sCOVG) assay (EUA Number: EUA202669) which is a chemiluminescent immunoassay intended for qualitative and semi-quantitative detection of IgG antibodies using the Atellica® IM Analyzer [1]. This SARS-CoV-2 IgG assay specifically detects IgG antibodies to the S1 receptor binding domain (RBD) antigen. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection or vaccination. The duration of time antibodies is present post-vaccination is not well characterized. The test will give an indication of the level of immunity that is provided by a vaccine for the SARS-CoV-2 virus which causes COVID-19.

The Atellica IM sCOVG assay is a fully automated 2 step sandwich immunoassay using indirect chemiluminescent technology. A direct relationship exists between the amount of SARS-CoV-2 IgG antibody present in a patient plasma sample and the amount of relative chemiluminescent light units (RLUs) detected by the system. Preparing master curves and performing calibrations of the system will be performed according to manufacturing instructions.

Results of the IgG antibody test are expressed as index values with an analytical measuring interval of 0.50-150.00 Index units. Plasma samples with index values >150 will be diluted and retested. Index values <1.00 will be considered negative (non-reactive) while values >1.00 will be considered positive (reactive) [1].

Total (IgM + IgG) antibodies to SARS-CoV-2 in human plasma (lithium-heparin) will be determined using the Siemen's Atellica® IM SARS-CoV-2 Total (COV2T) assay which is a chemiluminescent immunoassay intended for qualitative detection of total antibodies using the using the Atellica® IM Analyzer[1].

The Atellica IM COV2T assay is an automated immunoassay using indirect chemiluminescent technology [1]. Results of the total (IgM + IgG) antibody test are expressed as index values with an analytical measuring interval of 0.05-10.00 Index units. Index values <1.00 will be considered negative (non-reactive) while values >1.00 will be considered positive (reactive) [1]

[1]. https://www.siemens-healthineers.com/en-us/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/sars-cov-2-igg-assay

Data Management:

Demographic data of the subjects including characteristics, and medical histories including concomitant medications and disease states/conditions will be provided for each subject by the respective residence and inputted into the REDCap cloud platform (described below) by data input specialists employed by Southlake Diagnostics. Data entry will be checked by a second specialist for accuracy of entry. Standardized and approved terminology will be used for all entry parameters as height, weight, age, drug names, and disease states to ensure consistency of data entry. Data entry will be reviewed for accuracy of entry and validation by the Co-Principal Investigator (Dr. Robert Newton) who is responsible for this function, and the Principal Investigator.

Statistical Methods:

The laboratory will provide the certified statistician with a spread sheet of the data which will be sorted and analyzed as a whole and according to various parameters as gender, age groups, known disease states and immunocompetencies, physical characteristics and time after vaccination using a REDCap Cloud platform (www.redcapcloud.com/). This platform is advanced, compliant software for the management of all types of data associated with clinical studies. The system is Medical Dictionary for Regulatory Activities (MEdDRA) terminology certified, Clinical Data Interchange Standards Consortium (CDISC) compliant, and International Standards Organization (ISO) 27001 certified. The data will be sorted and analyzed for statistical significance and trends using various computer programs associated with the platform.

Information regarding overall duration and rate of decline of antibody levels as a function of time post-vaccination as well as the effects of confounding factors on antibody levels as a function of time will be determined. Information regarding antibody levels (IgG and total) and Covid-19 infection or reinfection, and approximate time at which a booster shot may be required will also be obtained relative to antibody levels. The large number of subjects in the overall study should enable statistical associations to be made between antibody levels and various potentially confounding and influencing factors. The data will be reviewed by the Principal Investigator and Co-PIs.

Study Design

• Study Type: Observational
• Estimated Enrollment: 10000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Blood samples will be drawn from an appropriate vein as the median cubital vein. Blood samples of 3.0 ml will be collected in mind green-topped plastic, BD Vacutainer PST blood collection tubes containing lithium-heparin using 21-23 gage needles, and stored at room temperature for not more than 6 hours before centrifugation on site to prepare plasma which will be sent to the analytical laboratory. The blood samples will be packed in biohazard, plastic leak-proof bags, and transported in insulated containers with cold packs to ensure the integrity of the samples, as necessary. Plasma samples will be stored at 2-8°C if not tested within 8 hours, and frozen if not tested within 14 days.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Residents and staff associated with nursing homes, extended care facilities and over-55 communities

Criteria

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.

Contacts and Locations

Contacts

Contact: Sidney J Stohs, Ph.D.; 1-214-215-6655; sid.stohs9@gmail.com; sid.stohs@bostonbiopharm.com

Contact: William Kraemer, Ph.D.; 1-860-208-5189; kraemer@osu.edu

Locations

United States, Texas

Southlake Diagnostics, Inc.; Recruiting

Southlake, Texas, United States, 76092

Contact: Desiree Brown, MA 214-697-9949 desiree@southlakedx.com

Contact: Sidney J. Stohs, Ph.D. 1-214-215-6655 sid.stohs@bostonbiopharm.com

Sponsors and Collaborators

Dr. Sidney J. Stohs

Telos Healthcare, LLC

Remarkable Healthcare

The Alden Network

Churchill Residential

Corridor Mobile Medical Services

Siemens Healthineers USA

HealthTrackRX/AIT

Abri Healthcare Services, LLC

Brookdale Senior Living, Inc.

Cantex Healthcare Centers, LLC

Christian Care Centers, Inc.

Cottonwood Creek Healthcare Community

Creative Solutions in Healthcare, Inc.

Dynasty Healthcare LLC

Midlothian Care Center

Nexion Health, Inc.

Optimum Healthcare, Inc.

Paramount Healthcare Consultants, LLC

Priority Healthcare, Inc.

Revelations Healthcare Group, LLC

Southwest Long Term Care, LLC

Stonegate Senior Living, LLC

Summit Healthcare, Inc.

TGR Healthcare, LLC

Trinity Healthcare, LLC

Investigators

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

More Information

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45. https://www.siemens-healthineers.com/en-us/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/sars-cov-2-igg-assay

• Responsible Party: Dr. Sidney J. Stohs, EVP Global Scientific Affairs, Boston Biopharm, Inc.
• ClinicalTrials.gov Identifier: NCT04944095
• Other Study ID Numbers: SARS-CoV-2 Antibodies Levels
• First Posted: June 29, 2021
• Last Update Posted: August 29, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: A plan is being developed whereby all IPD that is involved in publications will be shared with other investigators.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Data regarding results associated with each of the three authorized vaccines will be shared upon completion of the study with other investigators and with their respective manufacturers. If the investigators determine that significant interim results may be of value and contribute to overall healthcare, for example to determine potential timing of booster vaccinations, this information will be made available to appropriate parties prior to publication.
• Access Criteria: Governmental agencies as the Center for Disease Control, vaccine manufacturers, investigators with a track record in this area, and investigators with background deemed appropriate by the Principal and Co-Principal Investigators.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Sidney J. Stohs, Boston Biopharm, Inc.:

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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Antibodies; Immunologic Factors; Physiological Effects of Drugs