Immunogenicity Induced by COVID-19 Vaccines in Mexican Population

Completed

• Conditions: COVID-19 Vaccine
• Interventions: Other: Gene expression mRNA of IgG anti-spike

• Registration Number: NCT06597370
• Lead Sponsor: National Polytechnic Institute, Mexico

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).

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 Timeline

• Study Start: 2021-09-01
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-21
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Gene expression mRNA of IgG anti-spike	20 persons who have received the Oxford/AstraZeneca vaccine (ChAdOx1 nCoV-19).
Group 2	Gene expression mRNA of IgG anti-spike	20 persons who have received the vaccine Gamaleya National Center(Sputnik V)
Group 3	Gene expression mRNA of IgG anti-spike	20 persons who have received the Pfizer/BioNTech vaccine (BNT162b2).
Group 4	Gene expression mRNA of IgG anti-spike	20 persons who have received the Sinovac (CoronaVac) vaccine.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Escuela Superior de Medicina, Instituto Politécnico Nacional; 🇲🇽 Mexico City, Mexico