Clinical trial NCT04944095: Change in Antibody Levels Following SARS-CoV-2 (Covid-19) Vaccinations
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Subjects Vaccinated Against Covid-19
Keywords: IgG antibodies
total antibodies (IgG+ IgM)
age 55 and above
post-covid-19 vaccination
Confounding factors
Lead sponsor: Boston Biopharm, Inc.
Sponsor class: OTHER
Collaborators: name: Telos Healthcare, LLC
name: Remarkable Healthcare
name: The Alden Network
name: Churchill Residential
name: Corridor Mobile Medical Services
name: Siemens Healthineers USA
name: HealthTrackRX/AIT
name: Abri Healthcare Services, LLC
name: Brookdale Senior Living, Inc.
name: Cantex Healthcare Centers, LLC
name: Christian Care Centers, Inc.
name: Cottonwood Creek Healthcare Community
name: Creative Solutions in Healthcare, Inc.
name: Dynasty Healthcare LLC
name: Midlothian Care Center
name: Nexion Health, Inc.
name: Optimum Healthcare, Inc.
name: Paramount Healthcare Consultants, LLC
name: Priority Healthcare, Inc.
name: Revelations Healthcare Group, LLC
name: Southwest Long Term Care, LLC
name: Stonegate Senior Living, LLC
name: Summit Healthcare, Inc.
name: TGR Healthcare, LLC
name: Trinity Healthcare, LLC
First posted: 2021-06-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents and staff associated with nursing homes, extended care facilities and over-55 communities

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Plasma Antibody Levels with Time Following SARS-CoV-2 Vaccinations
timeFrame: Changes determined over 12 months (at baseline, 3,6, 9 and 12 months)
Secondary outcomes:
measure: Plasma Antibody Levels and Confounding Factors
timeFrame: Factors affecting changes over 12 months (determinations at baseline, 3,6, 9 and 12 months)
Other outcomes:
Locations:
city: Southlake
country: United States
facility: Southlake Diagnostics, Inc.
state: Texas
Study officials:
affiliation: Georgetown University, washington, DC
name: Harry G Preuss, MD
role: STUDY_DIRECTOR
affiliation: Edith Cowan University, Perth Western Australia
name: Robert U Newton, Ph.D.
role: STUDY_DIRECTOR
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