Immunogenicity Induced by COVID-19 Vaccines in Mexican Population (Vaccines COVID)

October 2, 2024 updated by: Modesto Gómez López, National Polytechnic Institute, Mexico

Immunogenicity Induced by COVID-19 Vaccines in Mexican Population: mRNA Expression for IgG Anti-spike

To determine the gene expression of anti-spike IgG through PCR-RT in patients vaccinated with the 4 types of vaccines available in Mexico Oxford/AstraZeneca (ChAdOx1 nCoV-19), Centro Nacional Gamaleya (Sputnik V), Pfizer/BioNTech (BNT162b2) and Sinovac (CoronaVac).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

80 subjects with full vaccination schedule will be included, 20 per group To know the gene expression of IgG anti-spike through PCR-RT in patients vaccinated with the 4 types of vaccines available in Mexico Oxford/AstraZeneca (ChAdOx1 nCoV-19), Centro Nacional Gamaleya (Sputnik V), Pfizer/BioNTech (BNT162b2) and Sinovac (CoronaVac).

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11340
        • Escuela Superior de Medicina, Instituto Politécnico Nacional

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Mexican men and women over 18 years of age, vaccinated in the last 4 months

Description

Inclusion Criteria:

  1. - Mexican people.
  2. - Over 18 years of age.
  3. - With complete vaccination schedule against COVID-19.
  4. - Allowing peripheral blood samples to be taken.
  5. - To sign an informed consent form.
  6. - To agree to participate in the protocol.

Exclusion Criteria:

  1. - Persons with incomplete vaccination schedule against COVID-19.
  2. - Persons who have 30 +/- 5 days of having completed the vaccination scheme against COVID-19.
  3. - People under treatment with any immunosuppressive drug.
  4. People who refuse to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
20 persons who have received the Oxford/AstraZeneca vaccine (ChAdOx1 nCoV-19).
Other: Gene expression mRNA of IgG anti-spike

b) Peripheral venous blood samples (3 ml per occasion) will be taken from all participants. They will be carried out on days 30,60 and 120 after completion of the COVID-19 vaccination schedule.

c) Sample processing:

  • tRNA extraction from all samples.
  • cDNA synthesis
  • Real time PCR performance.
Group 2
20 persons who have received the vaccine Gamaleya National Center(Sputnik V)
Other: Gene expression mRNA of IgG anti-spike

b) Peripheral venous blood samples (3 ml per occasion) will be taken from all participants. They will be carried out on days 30,60 and 120 after completion of the COVID-19 vaccination schedule.

c) Sample processing:

  • tRNA extraction from all samples.
  • cDNA synthesis
  • Real time PCR performance.
Group 3
20 persons who have received the Pfizer/BioNTech vaccine (BNT162b2).
Other: Gene expression mRNA of IgG anti-spike

b) Peripheral venous blood samples (3 ml per occasion) will be taken from all participants. They will be carried out on days 30,60 and 120 after completion of the COVID-19 vaccination schedule.

c) Sample processing:

  • tRNA extraction from all samples.
  • cDNA synthesis
  • Real time PCR performance.
Group 4
20 persons who have received the Sinovac (CoronaVac) vaccine.
Other: Gene expression mRNA of IgG anti-spike

b) Peripheral venous blood samples (3 ml per occasion) will be taken from all participants. They will be carried out on days 30,60 and 120 after completion of the COVID-19 vaccination schedule.

c) Sample processing:

  • tRNA extraction from all samples.
  • cDNA synthesis
  • Real time PCR performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity induced by COVID-19 vaccines in Mexican population
Time Frame: 4 months
To characterize the immunogenicity induced by COVID-19 vaccines in Mexican population: mRNA expression for IgG anti-spike.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Polytechnic Institute, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-01-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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