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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
Sponsor:
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.

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

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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

Resource links provided by the National Library of Medicine


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




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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

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


Contacts
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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
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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
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Study Director: Harry G Preuss, MD Georgetown University, washington, DC
Study Director: Robert U Newton, Ph.D. Edith Cowan University, Perth Western Australia
Publications:
Corbett 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.
Mercado 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. Erratum In: Nature. 2021 Feb;590(7844):E25.
14. 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
18. Iyer AS. Dynamics and significance of the antibody response to SARS-CoV-2. medRxiv. 2020.07.18.20155374. DOI:10.1101/2020.07.18.20155374
21. Poland GA, et al. SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates. Published online October 13, 2020. https://doi.org/10.1016/S0140-6736(20)32137-1
28. Keech C, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. DOI:10.1056/NEJMoa2026920 29. 49. Zhang, Y.J. et al. Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine in healthy adults aged 18-59 years: report of the randomized, double-blind, and placebo-controlled phase 2 clinical trial. medRxiv. 2020.07.31.20161216; https://doi.org/10.1101/2020.07.31.20161216
36. Bubar, K.M. et al. Model-informed COVID-19 vaccine prioritization strategies by age and serostatus. medRxiv 2020.09.08.20190629; https://doi.org/10.1101/2020.09.08.20190629
45. https://www.siemens-healthineers.com/en-us/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/sars-cov-2-igg-assay

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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    Key Record Dates
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.

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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:
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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