Immunogenicity Induced by COVID-19 Vaccines in Mexican Population

NCT06597370 | Completed DMC

• 1 other identifier: CEI-01-2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity induced by COVID-19 vaccines in Mexican population

  To characterize the immunogenicity induced by COVID-19 vaccines in Mexican population: mRNA expression for IgG anti-spike.

  4 months

Study Arms (4)

Group 1

20 persons who have received the Oxford/AstraZeneca vaccine (ChAdOx1 nCoV-19).

Other: Gene expression mRNA of IgG anti-spike

Group 2

20 persons who have received the vaccine Gamaleya National Center(Sputnik V)

Other: Gene expression mRNA of IgG anti-spike

Group 3

20 persons who have received the Pfizer/BioNTech vaccine (BNT162b2).

Other: Gene expression mRNA of IgG anti-spike

Group 4

20 persons who have received the Sinovac (CoronaVac) vaccine.

Other: Gene expression mRNA of IgG anti-spike

Interventions

Gene expression mRNA of IgG anti-spike OTHER

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 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Polytechnic Institute, Mexico: lead

Study Sites (1)

Escuela Superior de Medicina, Instituto Politécnico Nacional

Mexico City, 11340, Mexico

Location

Related Publications (15)

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Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Immunogenicity induced by COVID-19 vaccines in Mexican population: mRNA expression for IgG anti-spike.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 21, 2021
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

ME (1)