Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers Over 1 Year
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|ClinicalTrials.gov Identifier: NCT04910971|
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 2, 2021
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|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
|Group 1: Recipients of BNT162b2 mRNA Covid-19 Vaccine|
|Group 2: Recipients of mRNA-1273 SARS-CoV-2 Vaccine|
- 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
- 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
- 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
- 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.
- 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
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
|Contact: Paul A. Gurbel, MDemail@example.com|
|Contact: Kevin Bliden, MBAfirstname.lastname@example.org|
|United States, Maryland|
|Baltimore, Maryland, United States, 21215|
|Contact: kevin bliden, MBA 443-244-1497|
|Contact: Udaya Tantry, PhD 410-707-2655 email@example.com|
|Study Director:||Kevin Bliden, MBA||Sinai Center for Thrombosis Research|