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Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers Over 1 Year

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04910971
Recruitment Status : Unknown
Verified June 2021 by Paul A. Gurbel, LifeBridge Health.
Recruitment status was:  Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Information provided by (Responsible Party):
Paul A. Gurbel, LifeBridge Health

Brief Summary:

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a great challenge to global health. The first case was identified in December 2019 in Wuhan, China and since has infected nearly 100 million people and claimed almost 2 million lives worldwide. In response, the medical community and scientists have worked hard to develop effective therapies and guidelines to treat a wide range of symptoms including the use of the antiviral drug remdesivir, convalescent plasma, antibiotics, steroids, and anticoagulant therapy. To prevent the spread of the disease, multiple vaccines based on mRNA and DNA technologies that include inactivated viral components have been developed and millions of doses are currently being administered worldwide. Early analysis of data from the phase III Pfizer/BioNTech and Moderna vaccine trials suggested the vaccine was more than 90% effective in preventing the illness with a good safety profile (Polack et al., 2020). However, there are still many unknowns regarding the long-term safety of these newer vaccine technologies and the level and duration of immunogenicity.

SARS-CoV-2 infection results in seroconversion and production of anti-SARS-CoV-2 antibodies. The antibodies may suppress viral replication through neutralization but might also participate in COVID-19 pathogenesis through a process termed antibody-dependent enhancement (Lu et al., 2020). Rapid progress has been made in the research of antibody response and therapy in COVID-19 patients, including characterization of the clinical features of antibody responses in different populations infected by SARS-CoV-2, treatment of COVID-19 patients with convalescent plasma and intravenous immunoglobin products, isolation and characterization of a large panel of monoclonal neutralizing antibodies and early clinical testing, as well as clinical results from several COVID-19 vaccine candidates.

In this study, we plan to assess the effic of both vaccines on the healthcare workers. As healthcare workers begin to receive their first vaccination dosage, we will start looking for traces of antibodies within the blood and saliva. The data provided will help us determine the efficacy of the vaccine over a period of 1 year, identify any difference in efficacy amongst different populations (gender, age, and ethnicities) differences among vaccine types, demographics and follow-up on any potential side effects. We will collaborate with Nirmidas Biotech Inc. based in Palto Alto, California, a Stanford University spinoff on this project. Nirmidas Biotech. Inc is a young diagnostic company that have received several FDA EUA tests for COVID-19. We will perform IgG/IgM antibody detection by the NIRMIDAS MidaSpot™ COVID-19 Antibody Combo Detection Kit approved by FDA EUA for POC testing in our hospital site for qualitative antibody testing. We will then send dry blood spot and saliva to Nirmidas for the pGOLD™ COVID-19 High Accuracy IgG/IgM Assay to quantify antibody levels and avidity, both of which are important to immunity. The pGOLD assay is a novel nanotechnology assay platform capable of quantifying antibody levels and binding affinity to viruses. We collaborated recently with Nirmidas on this platform and published a joint paper in Nature Biomedical Engineering on COVID-19 Ab pGOLD assay (Liu et al., 2020). It is also capable of detecting antibodies in saliva samples and could offer a non-invasive approach to assessing antibody response for vaccination.

Condition or disease
COVID-19 Vaccine Corona Virus Infection Vaccine Adverse Reaction Vaccine Response Inflammation Thrombosis

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers Over 1 Year
Actual Study Start Date : January 31, 2021
Estimated Primary Completion Date : May 28, 2022
Estimated Study Completion Date : July 28, 2022

Resource links provided by the National Library of Medicine

Group 1: Recipients of BNT162b2 mRNA Covid-19 Vaccine
Group 2: Recipients of mRNA-1273 SARS-CoV-2 Vaccine

Primary Outcome Measures :
  1. Presence of IgG and IgM antibodies to SARS-CoV-2 in response to vaccination [ Time Frame: 3 months ]
    Detection and quantification of IgG and IgM antibodies to SARS-CoV-2 by the antibody-avidity assay test

  2. Loss of IgG and IgM antibodies to SARS-CoV-2 [ Time Frame: 12 months ]
    Loss of IgG and IgM antibodies to SARS-CoV-2 when tested by the antibody-avidity assay test and rapid COVID-19 Antibody Combo Detection Kit at days 0, 20, 45, 70, 3 months, 6 months, 9 months, 12 months post-vaccination, after initial detection of antibodies

Secondary Outcome Measures :
  1. Thrombo-inflammatory syndrome [ Time Frame: 12 months ]
    Frequency of thrombo-inflammatory syndrome as defined by urinary 11-dehdro thromboxane > 4200 pg/mg in subjects experiencing a moderate-severe reaction to immunization

  2. Side effects [ Time Frame: 12 months ]
    he occurrence and severity of reactogenicity in terms of solicited local and systemic adverse events after each vaccination for the duration of 1 year.

  3. Hypercoagulability [ Time Frame: 12 months ]
    Frequency of hypercoagulability as defined by increased platelet fibrin-clot strength as measured by Thrombelastography in subjects experiencing a moderate-severe reaction to immunization

Biospecimen Retention:   Samples Without DNA
Urine for urinary 11-dehdro thromboxane Blood for platelet fibrin-clot strength as measured by Thrombelastography, IgG and IgM antibodies to SARS-CoV-2

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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health care workers within a large health care system being administered FDA approved SARS-CoV-2 vaccinations

Inclusion Criteria:

  • Adult males or females aged 18 years and older (inclusive) at screening.
  • Able and willing (in the investigator's opinion) to comply with all study requirements.
  • Willing to discuss their relevant medical history with the study investigators.
  • Willing and able to give informed consent prior to study enrollment.

Exclusion Criteria:

  • History of a recent or previous COVID-19 infection per history or as detected by either the PGOLD™COVID-19 IGG/IGM ASSAY or MidaSpot™ COVID-19 Antibody fingerstick test.

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): NCT04910971

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Contact: Paul A. Gurbel, MD 410-601-5475 pgurbel@lifebridgehealth.org
Contact: Kevin Bliden, MBA 410-601-5475 kbliden@lifebridgehealth.org

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United States, Maryland
Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: kevin bliden, MBA    443-244-1497      
Contact: Udaya Tantry, PhD    410-707-2655    utantry@lifebridgehealth.org   
Sponsors and Collaborators
LifeBridge Health
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Study Director: Kevin Bliden, MBA Sinai Center for Thrombosis Research
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Responsible Party: Paul A. Gurbel, Principal Investigator, LifeBridge Health
ClinicalTrials.gov Identifier: NCT04910971    
Other Study ID Numbers: 1707882
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paul A. Gurbel, LifeBridge Health:
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases