Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra
- Conditions
- COVID-19
- Interventions
- Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab
- Registration Number
- NCT05172167
- Lead Sponsor
- Universidad de Antioquia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 infection Levels of IgG and IgM SARS-CoV-2 antibodies blood test. 40 patients diagnostic of COVID-19 Early vaccinated against COVID-19 Levels of IgG and IgM SARS-CoV-2 antibodies blood test. 80 subjects with less than 4 months after being fully vaccinated against COVID-19 Early vaccinated against COVID-19 RT-PCR SARS-CoV-2 nasopharyngeal swab 80 subjects with less than 4 months after being fully vaccinated against COVID-19 Late vaccinated against COVID-19 Levels of IgG and IgM SARS-CoV-2 antibodies blood test. 80 subjects with more than 4 months after being fully vaccinated against COVID-19 COVID-19 infection RT-PCR SARS-CoV-2 nasopharyngeal swab 40 patients diagnostic of COVID-19 Late vaccinated against COVID-19 RT-PCR SARS-CoV-2 nasopharyngeal swab 80 subjects with more than 4 months after being fully vaccinated against COVID-19
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Laboratorio Integrado de Medicina Especializada
🇨🇴Medellin, Antioquia, Colombia