NCT04944095

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

June 24, 2021

Last Update Submit

August 26, 2022

Conditions

Covid-19Subjects Vaccinated Against Covid-19

Keywords

IgG antibodiestotal antibodies (IgG+ IgM)age 55 and abovepost-covid-19 vaccinationConfounding factors

Outcome Measures

Primary Outcomes (1)

  • Changes in Plasma Antibody Levels with Time Following SARS-CoV-2 Vaccinations

    Determination of plasma IgG and total (IgG + IgM) antibody levels with time

    Changes determined over 12 months (at baseline, 3,6, 9 and 12 months)

Secondary Outcomes (1)

  • Plasma Antibody Levels and Confounding Factors

    Factors affecting changes over 12 months (determinations at baseline, 3,6, 9 and 12 months)

Study Arms (1)

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

Interventions

Change in SARS-CoV-2 Antibody LevelsOTHER

Changes in plasma antibody levels over 12 months will be determine post-vaccination with one of the authorized SARS-CoV-2 vaccines.

Also known as: No other names apply
SARS-CoV-2 Antibody Levels

Eligibility Criteria

Age55 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Male and female subjects of age 55 and above
  • Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

  • Individuals who are unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southlake Diagnostics, Inc.

Southlake, Texas, 76092, United States

RECRUITING

Related Publications (44)

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  • Seow J, Graham C, Merrick B, Acors S, Pickering S, Steel KJA, Hemmings O, O'Byrne A, Kouphou N, Galao RP, Betancor G, Wilson HD, Signell AW, Winstone H, Kerridge C, Huettner I, Jimenez-Guardeno JM, Lista MJ, Temperton N, Snell LB, Bisnauthsing K, Moore A, Green A, Martinez L, Stokes B, Honey J, Izquierdo-Barras A, Arbane G, Patel A, Tan MKI, O'Connell L, O'Hara G, MacMahon E, Douthwaite S, Nebbia G, Batra R, Martinez-Nunez R, Shankar-Hari M, Edgeworth JD, Neil SJD, Malim MH, Doores KJ. Longitudinal observation and decline of neutralizing antibody responses in the three months following SARS-CoV-2 infection in humans. Nat Microbiol. 2020 Dec;5(12):1598-1607. doi: 10.1038/s41564-020-00813-8. Epub 2020 Oct 26.

    PMID: 33106674BACKGROUND

  • Ibarrondo FJ, Fulcher JA, Goodman-Meza D, Elliott J, Hofmann C, Hausner MA, Ferbas KG, Tobin NH, Aldrovandi GM, Yang OO. Rapid Decay of Anti-SARS-CoV-2 Antibodies in Persons with Mild Covid-19. N Engl J Med. 2020 Sep 10;383(11):1085-1087. doi: 10.1056/NEJMc2025179. Epub 2020 Jul 21. No abstract available.

    PMID: 32706954BACKGROUND

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

    BACKGROUND

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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Harry G Preuss, MD

    Georgetown University, washington, DC

    STUDY DIRECTOR

  • Robert U Newton, Ph.D.

    Edith Cowan University, Perth Western Australia

    STUDY DIRECTOR

Central Study Contacts

Sidney J Stohs, Ph.D.

CONTACT

1-214-215-6655sid.stohs9@gmail.com; sid.stohs@bostonbiopharm.com

William Kraemer, Ph.D.

CONTACT

1-860-208-5189kraemer@osu.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
EVP Global Scientific Affairs

Study Record Dates

First Submitted

June 24, 2021

First Posted

June 29, 2021

Study Start

August 10, 2021

Primary Completion

August 9, 2024

Study Completion

December 31, 2024

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

A plan is being developed whereby all IPD that is involved in publications will be shared with other investigators.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

US(1)