CompletedNCT06597370Vaccines COVIDUpdated Oct 4, 2024

Immunogenicity Induced by COVID-19 Vaccines in Mexican Population

An observational study in COVID-19 Vaccine, sponsored by National Polytechnic Institute, Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by National Polytechnic Institute, Mexico · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 80
Ages: 18 Years and older
Sex: All

Study 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).

Read the 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).

Conditions studied

COVID-19 Vaccine

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COVID-19 7,640

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 80 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

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Lead sponsor

National Polytechnic Institute, Mexico is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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

Inclusion criteria

- 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.

Exclusion criteria

Exclusion Criteria:

- 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.

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 80 participants (actual)
Target follow-up: 4 Months
Patient registry: Yes

Groups and cohorts

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

OtherGene 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 researchers measure

Primary outcomes

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.
Time frame: 4 months

Study locations

1 site

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

References and documents

Publications

Meyerowitz EA, Richterman A, Gandhi RT, Sax PE. Transmission of SARS-CoV-2: A Review of Viral, Host, and Environmental Factors. Ann Intern Med. 2021 Jan;174(1):69-79. doi: 10.7326/M20-5008. Epub 2020 Sep 17. PubMed 32941052 ↗
Pal M, Berhanu G, Desalegn C, Kandi V. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2): An Update. Cureus. 2020 Mar 26;12(3):e7423. doi: 10.7759/cureus.7423. PubMed 32337143 ↗
Arya R, Kumari S, Pandey B, Mistry H, Bihani SC, Das A, Prashar V, Gupta GD, Panicker L, Kumar M. Structural insights into SARS-CoV-2 proteins. J Mol Biol. 2021 Jan 22;433(2):166725. doi: 10.1016/j.jmb.2020.11.024. Epub 2020 Nov 24. PubMed 33245961 ↗
Bourgonje AR, Abdulle AE, Timens W, Hillebrands JL, Navis GJ, Gordijn SJ, Bolling MC, Dijkstra G, Voors AA, Osterhaus AD, van der Voort PH, Mulder DJ, van Goor H. Angiotensin-converting enzyme 2 (ACE2), SARS-CoV-2 and the pathophysiology of coronavirus disease 2019 (COVID-19). J Pathol. 2020 Jul;251(3):228-248. doi: 10.1002/path.5471. Epub 2020 Jun 10. PubMed 32418199 ↗
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. PubMed 31978945 ↗
Masters PS, Perlman S. Coronaviridae. 6th ed. Campos virología de, editor. Fields Virology. 2013. 825-58 p.
Gonzalez JM, Gomez-Puertas P, Cavanagh D, Gorbalenya AE, Enjuanes L. A comparative sequence analysis to revise the current taxonomy of the family Coronaviridae. Arch Virol. 2003 Nov;148(11):2207-35. doi: 10.1007/s00705-003-0162-1. PubMed 14579179 ↗
Weiss SR, Navas-Martin S. Coronavirus pathogenesis and the emerging pathogen severe acute respiratory syndrome coronavirus. Microbiol Mol Biol Rev. 2005 Dec;69(4):635-64. doi: 10.1128/MMBR.69.4.635-664.2005. PubMed 16339739 ↗
Swelum AA, Shafi ME, Albaqami NM, El-Saadony MT, Elsify A, Abdo M, Taha AE, Abdel-Moneim AE, Al-Gabri NA, Almaiman AA, Saleh Al-Wajeeh A, Tufarelli V, Staffa VN, Abd El-Hack ME. COVID-19 in Human, Animal, and Environment: A Review. Front Vet Sci. 2020 Sep 4;7:578. doi: 10.3389/fvets.2020.00578. eCollection 2020. PubMed 33102545 ↗
Contini C, Di Nuzzo M, Barp N, Bonazza A, De Giorgio R, Tognon M, Rubino S. The novel zoonotic COVID-19 pandemic: An expected global health concern. J Infect Dev Ctries. 2020 Mar 31;14(3):254-264. doi: 10.3855/jidc.12671. PubMed 32235085 ↗
Majid S, Farooq R, Khan MS, Rashid S, Bhat SA, Wani HA, Qureshi W. Managing the COVID-19 Pandemic: Research Strategies Based on the Evolutionary and Molecular Characteristics of Coronaviruses. SN Compr Clin Med. 2020;2(10):1767-1776. doi: 10.1007/s42399-020-00457-z. Epub 2020 Aug 25. PubMed 32864575 ↗
Gorbalenya AE, Baker SC, Baric RS, de Groot RJ, Drosten C, Gulyaeva AA, et al. Severe acute respiratory syndrome-related coronavirus: The species and its viruses - a statement of the Coronavirus Study Group. bioRxiv. 2020;
Lu H, Stratton CW, Tang YW. Outbreak of pneumonia of unknown etiology in Wuhan, China: The mystery and the miracle. J Med Virol. 2020 Apr;92(4):401-402. doi: 10.1002/jmv.25678. Epub 2020 Feb 12. No abstract available. PubMed 31950516 ↗
Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. Addendum: A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Dec;588(7836):E6. doi: 10.1038/s41586-020-2951-z. No abstract available. PubMed 33199918 ↗
Park SE. Epidemiology, virology, and clinical features of severe acute respiratory syndrome -coronavirus-2 (SARS-CoV-2; Coronavirus Disease-19). Clin Exp Pediatr. 2020 Apr;63(4):119-124. doi: 10.3345/cep.2020.00493. Epub 2020 Apr 2. PubMed 32252141 ↗

Study documents

Protocol and statistical analysis plan · Jul 10, 2021
Informed consent form · Jul 10, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06597370
Lead sponsor: National Polytechnic Institute, Mexico
Responsible party: Modesto Gómez López (Immunogenicity induced by COVID-19 vaccines in Mexican population: mRNA expression for IgG anti-spike., National Polytechnic Institute, Mexico) — Principal investigator
First posted: Sep 19, 2024
Start date: Sep 1, 2021
Primary completion: Dec 20, 2021
Completion: Dec 21, 2021
Last update: Oct 4, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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