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

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05172167

Enrollment

200

Registered

2021-12-29

Start date

2022-02-02

Completion date

2022-04-30

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Laboratory biomarkers, Health condition, COVID-19, Antibodies level, Vaccinated people

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.

Interventions

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

0,1,2 months

DIAGNOSTIC_TESTRT-PCR SARS-CoV-2 nasopharyngeal swab

0,1,2 months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Colombia

Contacts

Primary ContactIvone Jimenez

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026