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

Universidad de Antioquia200 enrolled

Overview

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.

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

200

Conditions

COVID-19

Interventions

Levels of IgG and IgM SARS-CoV-2 antibodies blood test.DIAGNOSTIC_TEST

0,1,2 months

RT-PCR SARS-CoV-2 nasopharyngeal swabDIAGNOSTIC_TEST

0,1,2 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Laboratorio Integrado de Medicina Especializada

Medellín, Antioquia, Colombia

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

SARS-CoV-2 infections in vaccinated patients against COVID-19.

Time frame: 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

Central Contacts

Ivone Jimenez

CONTACT

+57 (4) 2196022 ivone.jimenez@udea.edu.co

Data from ClinicalTrials.gov

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