Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra

February 24, 2022 updated by: Andres Felipe Zuluaga Salazar, Universidad de Antioquia

Prospective Evaluation of Antibodies Levels Variation Against SARS-CoV-2 in a Vaccinated Population of the Metropolitan Area of Valle de Aburra . Pilot Prospective Cohort.

Recent research evidence shows that levels of antibodies acquierd post vacunation against SARS-Cov-2 decrease over time as well as the efficacy to control the infection, additionally in a multicenter study carried out in 2020 were evidenced differences in the time it took to decrease the antibodies according to the type of vaccine, defined as mRNA or other types of vaccine.

In this study , the variation of the SARS-Cov-2 antibody levels in patients from Valle de Aburrá will be correlated according to the COVID-19 vaccine received.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, all patients giving written informed consent will undergo a serial IgM -IgG COVID-19 antibodies blood test and SARS-Cov-2 PCR by nasopharingeal swab, that will be taken at the beginning of the study and mensually for two months.

During the study will be done an active search for SARS-CoV-2 infections in the vaccinated people cohort, and if it is posible to characterize the variant of SARS-CoV-2 in participants previously vaccinated against this pathogen.

The main objective of this study is to describe the pattern of antibodies blood test based in the type of vaccine and correlated the pattern of antibodies SARS-Cov-2 levels in a population of Valle de Aburrá.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050022
        • Recruiting
        • Laboratorio Integrado de Medicina Especializada
        • Contact:
          • Andres F Zuluaga

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with a fully vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia and patients diagnosed with SARS-CoV-2 infection in the last 60 days, without matter vaccination status against SARS-CoV-2.

Description

Inclusion Criteria:

  • Adult over 18 years old
  • The vaccinated patients to be included must have received a complete vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia
  • SARS-CoV-2 infection in the last 2 months, verified by rtPCR test

Exclusion Criteria:

  • Immunocompromised patients
  • Immunosuppressive treatments, chemotherapy or antiretroviral therapy
  • Outpatient anticoagulant therapy
  • For vaccinated people (groups 1 and 2): if have had COVID-19 infection in the last 6 months

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early vaccinated against COVID-19
80 subjects with less than 4 months after being fully vaccinated against COVID-19
Diagnostic test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.
0,1,2 months
Diagnostic test: RT-PCR SARS-CoV-2 nasopharyngeal swab
0,1,2 months
Late vaccinated against COVID-19
80 subjects with more than 4 months after being fully vaccinated against COVID-19
Diagnostic test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.
0,1,2 months
Diagnostic test: RT-PCR SARS-CoV-2 nasopharyngeal swab
0,1,2 months
COVID-19 infection
40 patients diagnostic of COVID-19
Diagnostic test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.
0,1,2 months
Diagnostic test: RT-PCR SARS-CoV-2 nasopharyngeal swab
0,1,2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IgG and IgM antibodies blood test levels generated by the different COVID-19 vaccines in people throughout the time of the study.
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparing immunoglobulins M and G levels in vaccinated patients against SARS-CoV-2 with RNA and non RNA vaccines.
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
SARS-CoV-2 infections in vaccinated patients against COVID-19.
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months
Correlate through time immunoglobulins M and G levels in people vaccinated against COVID-19 and SARS-CoV-2 acute infected patients.
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months

Collaborators and Investigators

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

Sponsor

Universidad de Antioquia

Collaborators

Laboratorio integrado de medicina especializada(LIME)
Proyecto de regalias BPIN 2020000100152

Investigators

  • Principal Investigator: Andrés F Zuluaga, MD, MSc, MeH, Universidad de Antioquia

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)

February 2, 2022

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIME-21-P-02

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

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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