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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.
* Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early vaccinated against COVID-19<br>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.<br>* 0,1,2 months<br>Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab<br>* 0,1,2 months<br>|
| Late vaccinated against COVID-19<br>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.<br>* 0,1,2 months<br>Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab<br>* 0,1,2 months<br>|
| COVID-19 infection<br>40 patients diagnostic of COVID-19 | Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.<br>* 0,1,2 months<br>Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab<br>* 0,1,2 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing immunoglobulins M and G levels in vaccinated patients against SARS-CoV-2 with RNA and non RNA vaccines. |  | Through study completion, an average of 2 months | 
| SARS-CoV-2 infections in vaccinated patients against COVID-19. |  | 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. |  | Through study completion, an average of 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Laboratory biomarkers, Health condition, Antibodies level, Vaccinated people