Clinical trial NCT05172167: Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Laboratory biomarkers
Health condition
COVID-19
Antibodies level
Vaccinated people
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Laboratorio integrado de medicina especializada(LIME)
name: Proyecto de regalias BPIN 2020000100152
First posted: 2021-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: IgG and IgM antibodies blood test levels generated by the different COVID-19 vaccines in people throughout the time of the study.
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: Comparing immunoglobulins M and G levels in vaccinated patients against SARS-CoV-2 with RNA and non RNA vaccines.
timeFrame: Through study completion, an average of 2 months
measure: SARS-CoV-2 infections in vaccinated patients against COVID-19.
timeFrame: Through study completion, an average of 2 months
measure: Correlate through time immunoglobulins M and G levels in people vaccinated against COVID-19 and SARS-CoV-2 acute infected patients.
timeFrame: Through study completion, an average of 2 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Laboratorio Integrado de Medicina Especializada
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Andres F Zuluaga, MD, MSc, MeH
role: PRINCIPAL_INVESTIGATOR
References: