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

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 15, 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Early vaccinated against COVID-19
    • 80 subjects with less than 4 months after being fully vaccinated against COVID-19
  • Late vaccinated against COVID-19
    • 80 subjects with more than 4 months after being fully vaccinated against COVID-19
  • COVID-19 infection
    • 40 patients diagnostic of COVID-19

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidad de Antioquia
  • Collaborator
    • Laboratorio integrado de medicina especializada(LIME)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andres Felipe Zuluaga Salazar, Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University – Universidad de Antioquia
  • Overall Official(s)
    • Andres F Zuluaga, MD, MSc, MeH, Principal Investigator, Universidad de Antioquia
  • Overall Contact(s)
    • Ivone Jimenez, +57 (4) 2196022, ivone.jimenez@udea.edu.co

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.