Covid-19Covid-19-AbsNCT04944095
Change in Antibody Levels Following SARS-CoV-2 (Covid-19) Vaccinations
An observational study of Covid-19 and Subjects Vaccinated Against Covid-19, run by Dr. Sidney J. Stohs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Covid-19, Subjects Vaccinated Against Covid-19
- What is being tested?
- Change in SARS-CoV-2 Antibody Levels
- Type of treatment
- Vaccines
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Adult, Older adult
Study population: Residents and staff associated with nursing homes, extended care facilities and over-55 communities
Who may be able to join
- Male and female subjects of age 55 and above
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Individuals who are unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southlake Diagnostics, Inc.
Southlake, Texas, 76092
Desiree Brown, MA, 214-697-9949, desiree@southlakedx.com
Sidney J. Stohs, Ph.D., 1-214-215-6655, sid.stohs@bostonbiopharm.com
About this study
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
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.
Read the 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.
- Conditions
- Covid-19, Subjects Vaccinated Against Covid-19
- Being tested
- Change in SARS-CoV-2 Antibody Levels
- Keywords
- IgG antibodies, total antibodies (IgG+ IgM), age 55 and above, post-covid-19 vaccination, Confounding factors
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in SARS-CoV-2 Antibody LevelsOther
Also called No other names apply
Changes in plasma antibody levels over 12 months will be determine post-vaccination with one of the authorized SARS-CoV-2 vaccines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Change in SARS-CoV-2 Antibody Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Plasma Antibody Levels with Time Following SARS-CoV-2 Vaccinations
Determination of plasma IgG and total (IgG + IgM) antibody levels with time
Measured: Changes determined over 12 months (at baseline, 3,6, 9 and 12 months)
Secondary outcomes (1)
Plasma Antibody Levels and Confounding Factors
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.
Measured: Factors affecting changes over 12 months (determinations at baseline, 3,6, 9 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start10 Aug 2021
- Primary completion9 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sidney J. Stohs
- Sponsor type
- University, hospital or other
- Collaborators
- Telos Healthcare, LLC, Remarkable Healthcare, The Alden Network, Churchill Residential, Corridor Mobile Medical Services, Siemens Healthineers, 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
- Responsible party
- Sponsor-investigator, Dr. Sidney J. Stohs, Boston Biopharm, Inc.
- Investigators
- Harry G Preuss, MD, Study director, Georgetown University, washington, DCRobert U Newton, Ph.D., Study director, Edith Cowan University, Perth Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944095
- Sponsor's protocol ID
- SARS-CoV-2 Antibodies Levels
- Acronym
- Covid-19-Abs
- Status last verified
- Aug 2022
- First submitted
- 24 Jun 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A plan is being developed whereby all IPD that is involved in publications will be shared with other investigators.
Publications
VanBlargan LA, Goo L, Pierson TC. Deconstructing the Antiviral Neutralizing-Antibody Response: Implications for Vaccine Development and Immunity. Microbiol Mol Biol Rev. 2016 Oct 26;80(4):989-1010. doi: 10.1128/MMBR.00024-15. Print 2016 Dec.
PubMed 27784796Piccoli L, Park YJ, Tortorici MA, Czudnochowski N, Walls AC, Beltramello M, Silacci-Fregni C, Pinto D, Rosen LE, Bowen JE, Acton OJ, Jaconi S, Guarino B, Minola A, Zatta F, Sprugasci N, Bassi J, Peter A, De Marco A, Nix JC, Mele F, Jovic S, Rodriguez BF, Gupta SV, Jin F, Piumatti G, Lo Presti G, Pellanda AF, Biggiogero M, Tarkowski M, Pizzuto MS, Cameroni E, Havenar-Daughton C, Smithey M, Hong D, Lepori V, Albanese E, Ceschi A, Bernasconi E, Elzi L, Ferrari P, Garzoni C, Riva A, Snell G, Sallusto F, Fink K, Virgin HW, Lanzavecchia A, Corti D, Veesler D. Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology. Cell. 2020 Nov 12;183(4):1024-1042.e21. doi: 10.1016/j.cell.2020.09.037. Epub 2020 Sep 16.
PubMed 32991844Premkumar L, Segovia-Chumbez B, Jadi R, Martinez DR, Raut R, Markmann A, Cornaby C, Bartelt L, Weiss S, Park Y, Edwards CE, Weimer E, Scherer EM, Rouphael N, Edupuganti S, Weiskopf D, Tse LV, Hou YJ, Margolis D, Sette A, Collins MH, Schmitz J, Baric RS, de Silva AM. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol. 2020 Jun 11;5(48):eabc8413. doi: 10.1126/sciimmunol.abc8413.
PubMed 32527802Wang H, Zhang Y, Huang B, Deng W, Quan Y, Wang W, Xu W, Zhao Y, Li N, Zhang J, Liang H, Bao L, Xu Y, Ding L, Zhou W, Gao H, Liu J, Niu P, Zhao L, Zhen W, Fu H, Yu S, Zhang Z, Xu G, Li C, Lou Z, Xu M, Qin C, Wu G, Gao GF, Tan W, Yang X. Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2. Cell. 2020 Aug 6;182(3):713-721.e9. doi: 10.1016/j.cell.2020.06.008. Epub 2020 Jun 6.
PubMed 32778225Addetia A, Crawford KHD, Dingens A, Zhu H, Roychoudhury P, Huang ML, Jerome KR, Bloom JD, Greninger AL. Neutralizing Antibodies Correlate with Protection from SARS-CoV-2 in Humans during a Fishery Vessel Outbreak with a High Attack Rate. J Clin Microbiol. 2020 Oct 21;58(11):e02107-20. doi: 10.1128/JCM.02107-20. Print 2020 Oct 21.
PubMed 32826322Corbett KS, Flynn B, Foulds KE, Francica JR, Boyoglu-Barnum S, Werner AP, Flach B, O'Connell S, Bock KW, Minai M, Nagata BM, Andersen H, Martinez DR, Noe AT, Douek N, Donaldson MM, Nji NN, Alvarado GS, Edwards DK, Flebbe DR, Lamb E, Doria-Rose NA, Lin BC, Louder MK, O'Dell S, Schmidt SD, Phung E, Chang LA, Yap C, Todd JM, Pessaint L, Van Ry A, Browne S, Greenhouse J, Putman-Taylor T, Strasbaugh A, Campbell TA, Cook A, Dodson A, Steingrebe K, Shi W, Zhang Y, Abiona OM, Wang L, Pegu A, Yang ES, Leung K, Zhou T, Teng IT, Widge A, Gordon I, Novik L, Gillespie RA, Loomis RJ, Moliva JI, Stewart-Jones G, Himansu S, Kong WP, Nason MC, Morabito KM, Ruckwardt TJ, Ledgerwood JE, Gaudinski MR, Kwong PD, Mascola JR, Carfi A, Lewis MG, Baric RS, McDermott A, Moore IN, Sullivan NJ, Roederer M, Seder RA, Graham BS. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. N Engl J Med. 2020 Oct 15;383(16):1544-1555. doi: 10.1056/NEJMoa2024671. Epub 2020 Jul 28.
PubMed 32722908Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Tureci O, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Sahin U, Gruber WC. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N Engl J Med. 2020 Dec 17;383(25):2439-2450. doi: 10.1056/NEJMoa2027906. Epub 2020 Oct 14.
PubMed 33053279Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, Liu J, Peter L, McMahan K, Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, van Manen D, Vellinga J, Custers J, Langedijk JP, Kwaks T, Bakkers MJG, Zuijdgeest D, Rosendahl Huber SK, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Hoffman E, Jacob-Dolan C, Kirilova M, Li Z, Lin Z, Mahrokhian SH, Maxfield LF, Nampanya F, Nityanandam R, Nkolola JP, Patel S, Ventura JD, Verrington K, Wan H, Pessaint L, Van Ry A, Blade K, Strasbaugh A, Cabus M, Brown R, Cook A, Zouantchangadou S, Teow E, Andersen H, Lewis MG, Cai Y, Chen B, Schmidt AG, Reeves RK, Baric RS, Lauffenburger DA, Alter G, Stoffels P, Mammen M, Van Hoof J, Schuitemaker H, Barouch DH. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature. 2020 Oct;586(7830):583-588. doi: 10.1038/s41586-020-2607-z. Epub 2020 Jul 30.
PubMed 32731257Wajnberg A, Amanat F, Firpo A, Altman DR, Bailey MJ, Mansour M, McMahon M, Meade P, Mendu DR, Muellers K, Stadlbauer D, Stone K, Strohmeier S, Simon V, Aberg J, Reich DL, Krammer F, Cordon-Cardo C. Robust neutralizing antibodies to SARS-CoV-2 infection persist for months. Science. 2020 Dec 4;370(6521):1227-1230. doi: 10.1126/science.abd7728. Epub 2020 Oct 28.
PubMed 33115920Chen X, Pan Z, Yue S, Yu F, Zhang J, Yang Y, Li R, Liu B, Yang X, Gao L, Li Z, Lin Y, Huang Q, Xu L, Tang J, Hu L, Zhao J, Liu P, Zhang G, Chen Y, Deng K, Ye L. Disease severity dictates SARS-CoV-2-specific neutralizing antibody responses in COVID-19. Signal Transduct Target Ther. 2020 Sep 2;5(1):180. doi: 10.1038/s41392-020-00301-9.
PubMed 32879307Hassan AO, Case JB, Winkler ES, Thackray LB, Kafai NM, Bailey AL, McCune BT, Fox JM, Chen RE, Alsoussi WB, Turner JS, Schmitz AJ, Lei T, Shrihari S, Keeler SP, Fremont DH, Greco S, McCray PB Jr, Perlman S, Holtzman MJ, Ellebedy AH, Diamond MS. A SARS-CoV-2 Infection Model in Mice Demonstrates Protection by Neutralizing Antibodies. Cell. 2020 Aug 6;182(3):744-753.e4. doi: 10.1016/j.cell.2020.06.011. Epub 2020 Jun 10.
PubMed 32553273Krammer F. SARS-CoV-2 vaccines in development. Nature. 2020 Oct;586(7830):516-527. doi: 10.1038/s41586-020-2798-3. Epub 2020 Sep 23.
PubMed 3296700614. Muecksch F, et al. Longitudinal analysis of clinical serology assay performance and neutralising antibody levels in COVID19 convalescents. medRxiv. 2020.08.05.20169128. https://doi.org/10.1101/2020.08.05.20169128
15. Ripperger TJ, et al. Detection, prevalence, and duration of humoral responses to SARS-CoV-2 under conditions of limited population exposure. medRxiv. 2020.08.14.20174490; DOI: https://doi. org/10.1101/2020.08.14.20174490
16. Grandjean L, et al. Humoral response dynamics following infection with SARS-CoV-2. medRxiv. 2020.07.16.20155663; https://doi.org/10.1101/2020.07.16.20155663
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04944095
- Acronym / sponsor ID
- Covid-19-Abs / SARS-CoV-2 Antibodies Levels
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Dr. Sidney J. StohsUniversity, hospital or other
- Collaborators
- Telos Healthcare, LLC, Remarkable Healthcare, The Alden Network, Churchill Residential, Corridor Mobile Medical Services, Siemens Healthineers, 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
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 9 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Antibody Levels | – | Other: Change in SARS-CoV-2 Antibody LevelsThis 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Residents and staff associated with nursing homes, extended care facilities and over-55 communities
Key inclusion criteria (2 listed)
- Male and female subjects of age 55 and above
- Has given voluntary, written, informed consent to participate in the study
Key exclusion criteria (1 listed)
- Individuals who are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in SARS-CoV-2 Antibody LevelsAlso: No other names applyChanges in plasma antibody levels over 12 months will be determine post-vaccination with one of the authorized SARS-CoV-2 vaccines. | Other | SARS-CoV-2 Antibody Levels |
Primary outcome
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
1 secondary outcome
Plasma Antibody Levels and Confounding Factors
Time frame: Factors affecting changes over 12 months (determinations at baseline, 3,6, 9 and 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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- Background: PubMed 32527802Premkumar L, Segovia-Chumbez B, Jadi R, Martinez DR, Raut R, Markmann A, Cornaby C, Bartelt L, Weiss S, Park Y, Edwards CE, Weimer E, Scherer EM, Rouphael N, Edupuganti S, Weiskopf D, Tse LV, Hou YJ, Margolis D, Sette A, Collins MH, Schmitz J, Baric RS, de Silva AM. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol. 2020 Jun 11;5(48):eabc8413. doi: 10.1126/sciimmunol.abc8413.
- Background: PubMed 32778225Wang H, Zhang Y, Huang B, Deng W, Quan Y, Wang W, Xu W, Zhao Y, Li N, Zhang J, Liang H, Bao L, Xu Y, Ding L, Zhou W, Gao H, Liu J, Niu P, Zhao L, Zhen W, Fu H, Yu S, Zhang Z, Xu G, Li C, Lou Z, Xu M, Qin C, Wu G, Gao GF, Tan W, Yang X. Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2. Cell. 2020 Aug 6;182(3):713-721.e9. doi: 10.1016/j.cell.2020.06.008. Epub 2020 Jun 6.
- Background: PubMed 32826322Addetia A, Crawford KHD, Dingens A, Zhu H, Roychoudhury P, Huang ML, Jerome KR, Bloom JD, Greninger AL. Neutralizing Antibodies Correlate with Protection from SARS-CoV-2 in Humans during a Fishery Vessel Outbreak with a High Attack Rate. J Clin Microbiol. 2020 Oct 21;58(11):e02107-20. doi: 10.1128/JCM.02107-20. Print 2020 Oct 21.
- Background: PubMed 32722908Corbett KS, Flynn B, Foulds KE, Francica JR, Boyoglu-Barnum S, Werner AP, Flach B, O'Connell S, Bock KW, Minai M, Nagata BM, Andersen H, Martinez DR, Noe AT, Douek N, Donaldson MM, Nji NN, Alvarado GS, Edwards DK, Flebbe DR, Lamb E, Doria-Rose NA, Lin BC, Louder MK, O'Dell S, Schmidt SD, Phung E, Chang LA, Yap C, Todd JM, Pessaint L, Van Ry A, Browne S, Greenhouse J, Putman-Taylor T, Strasbaugh A, Campbell TA, Cook A, Dodson A, Steingrebe K, Shi W, Zhang Y, Abiona OM, Wang L, Pegu A, Yang ES, Leung K, Zhou T, Teng IT, Widge A, Gordon I, Novik L, Gillespie RA, Loomis RJ, Moliva JI, Stewart-Jones G, Himansu S, Kong WP, Nason MC, Morabito KM, Ruckwardt TJ, Ledgerwood JE, Gaudinski MR, Kwong PD, Mascola JR, Carfi A, Lewis MG, Baric RS, McDermott A, Moore IN, Sullivan NJ, Roederer M, Seder RA, Graham BS. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. N Engl J Med. 2020 Oct 15;383(16):1544-1555. doi: 10.1056/NEJMoa2024671. Epub 2020 Jul 28.
- Background: PubMed 33053279Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Tureci O, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Sahin U, Gruber WC. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. N Engl J Med. 2020 Dec 17;383(25):2439-2450. doi: 10.1056/NEJMoa2027906. Epub 2020 Oct 14.
- Background: PubMed 32731257Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, Liu J, Peter L, McMahan K, Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, van Manen D, Vellinga J, Custers J, Langedijk JP, Kwaks T, Bakkers MJG, Zuijdgeest D, Rosendahl Huber SK, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Hoffman E, Jacob-Dolan C, Kirilova M, Li Z, Lin Z, Mahrokhian SH, Maxfield LF, Nampanya F, Nityanandam R, Nkolola JP, Patel S, Ventura JD, Verrington K, Wan H, Pessaint L, Van Ry A, Blade K, Strasbaugh A, Cabus M, Brown R, Cook A, Zouantchangadou S, Teow E, Andersen H, Lewis MG, Cai Y, Chen B, Schmidt AG, Reeves RK, Baric RS, Lauffenburger DA, Alter G, Stoffels P, Mammen M, Van Hoof J, Schuitemaker H, Barouch DH. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature. 2020 Oct;586(7830):583-588. doi: 10.1038/s41586-020-2607-z. Epub 2020 Jul 30.
- Background: PubMed 33115920Wajnberg A, Amanat F, Firpo A, Altman DR, Bailey MJ, Mansour M, McMahon M, Meade P, Mendu DR, Muellers K, Stadlbauer D, Stone K, Strohmeier S, Simon V, Aberg J, Reich DL, Krammer F, Cordon-Cardo C. Robust neutralizing antibodies to SARS-CoV-2 infection persist for months. Science. 2020 Dec 4;370(6521):1227-1230. doi: 10.1126/science.abd7728. Epub 2020 Oct 28.
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- Individual participant dataSharing planned: Yes. A plan is being developed whereby all IPD that is involved in publications will be shared with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry G Preuss, MD study director
Georgetown University, washington, DC
Robert U Newton, Ph.D. study director
Edith Cowan University, Perth Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Subjects Vaccinated Against Covid-19, run by Dr. Sidney J. Stohs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sidney J Stohs, Ph.D. (1-214-215-6655, sid.stohs9@gmail.com; sid.stohs@bostonbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944095, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.