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

• Sponsor: Universidad de Antioquia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05172167
• Collaborator: Laboratorio integrado de medicina especializada(LIME) (Other), Proyecto de regalias BPIN 2020000100152 (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 2.9
• Patients Per Site Per Month: 70

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: Levels of IgG and IgM SARS-CoV-2 antibodies blood test.; Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Feb 2, 2022
• Anticipated Primary Completion Date: Apr 15, 2022
• Anticipated Study Completion Date: Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Early vaccinated against COVID-19 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.; 0,1,2 months; Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab; 0,1,2 months
Late vaccinated against COVID-19 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.; 0,1,2 months; Diagnostic Test: RT-PCR SARS-CoV-2 nasopharyngeal swab; 0,1,2 months
COVID-19 infection 40 patients diagnostic of COVID-19	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

2. SARS-CoV-2 infections in vaccinated patients against COVID-19. [Through study completion, an average of 2 months]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratorio Integrado de Medicina Especializada	Medellin	Antioquia	Colombia	050022

Sponsors and Collaborators

• Universidad de Antioquia
• Laboratorio integrado de medicina especializada(LIME)
• Proyecto de regalias BPIN 2020000100152

Investigators

• Principal Investigator: Andres F Zuluaga, MD, MSc, MeH, Universidad de Antioquia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andres Felipe Zuluaga Salazar, Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University, Universidad de Antioquia
• ClinicalTrials.gov Identifier: NCT05172167
• Other Study ID Numbers: LIME-21-P-02
• First Posted: Dec 29, 2021
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andres Felipe Zuluaga Salazar, Full profesor, senior researcher and head of the Department of Pharmacology and Toxicology in Antioquia University, Universidad de Antioquia: Laboratory biomarkers; Health condition; COVID-19; Antibodies level; Vaccinated people
• Additional relevant MeSH terms: COVID-19; Antibodies

Study Results

No Results Posted as of Mar 2, 2022