SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida

September 30, 2022 updated by: H. Lee Moffitt Cancer Center and Research Institute

SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida

The overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community Sample

Description

Inclusion Criteria:

  • Resident of Hillsborough County, Florida
  • 18 years of age or older
  • Currently not exhibiting symptoms of SARS-CoV-2 infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants age 18-34
Up to 300 participants age 18-34 who received an invitation by mail and are free of fever at time of interview.
Diagnostic test: SARS-CoV-2 Antibody Analysis
10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.
Diagnostic test: Weck-cel Swab Collection
A Weck-cel swab will be used to collect secretions from the mucosal epithelium
Behavioral: Web Based Questionnaire
A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.
Participants age 35-54
Up to 300 Participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Diagnostic test: SARS-CoV-2 Antibody Analysis
10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.
Diagnostic test: Weck-cel Swab Collection
A Weck-cel swab will be used to collect secretions from the mucosal epithelium
Behavioral: Web Based Questionnaire
A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.
Participants age 55-64
Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Diagnostic test: SARS-CoV-2 Antibody Analysis
10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.
Diagnostic test: Weck-cel Swab Collection
A Weck-cel swab will be used to collect secretions from the mucosal epithelium
Behavioral: Web Based Questionnaire
A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.
Participants 65 and over
Up to 300 participants age 35-54 who received an invitation by mail and are free of fever at time of interview.
Diagnostic test: SARS-CoV-2 Antibody Analysis
10 ml of blood will be drawn for antibody analysis. Participants who test SARCS-CoV-2 positive will be invited to participate in follow-up antibody testing at 4 weeks and at 3 months.
Diagnostic test: Weck-cel Swab Collection
A Weck-cel swab will be used to collect secretions from the mucosal epithelium
Behavioral: Web Based Questionnaire
A brief web enabled questionnaire will be administered to collect information related to demographics, SARS-CoV-2 exposure history, past symptoms, comorbidities associates with increased infection and disease risk, as well as immunosuppression status and use to immunosuppressive medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit
Time Frame: At study start
All participants who respond to study invitation letter will be tested for SARS-CoV-2 antibodies after completing a web-based questionnaire.
At study start
Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit
Time Frame: At 4 weeks
Participants who tested positive for SARS-CoV-2 antibodies at first study visit will be tested for antibodies to SARS-CoV-2 again at 4 weeks.
At 4 weeks
Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit
Time Frame: At 3 months
Participants who tested positive for SARS-CoV-2 antibodies at second study visit will be tested for antibodies to SARS-CoV-2 again at 3 months.
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Anna R Giuliano, PhD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2020

Primary Completion (Actual)

July 25, 2021

Study Completion (Actual)

July 25, 2021

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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