COVID-19 VaccineVaccines COVIDNCT06597370
Immunogenicity Induced by COVID-19 Vaccines in Mexican Population
An observational study of COVID-19 Vaccine, run by National Polytechnic Institute, Mexico at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- What is being tested?
- Gene expression mRNA of IgG anti-spike
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2021to 21 Dec 2021
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mexican men and women over 18 years of age, vaccinated in the last 4 months
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Escuela Superior de Medicina, Instituto Politécnico Nacional
Mexico City, 11340
About this study
Official title: 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).
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
- COVID-19 Vaccine
- Being tested
- Gene expression mRNA of IgG anti-spike
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene expression mRNA of IgG anti-spikeOther
- 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.
- Sample processing:
- tRNA extraction from all samples.
- cDNA synthesis
- Real time PCR performance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 20 persons who have received the Oxford/AstraZeneca vaccine (ChAdOx1 nCoV-19). Receives: Other: Gene expression mRNA of IgG anti-spike | |
| Group 2 | 20 persons who have received the vaccine Gamaleya National Center(Sputnik V) Receives: Other: Gene expression mRNA of IgG anti-spike | |
| Group 3 | 20 persons who have received the Pfizer/BioNTech vaccine (BNT162b2). Receives: Other: Gene expression mRNA of IgG anti-spike | |
| Group 4 | 20 persons who have received the Sinovac (CoronaVac) vaccine. Receives: Other: Gene expression mRNA of IgG anti-spike |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2021
- Primary completion20 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- National Polytechnic Institute, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Modesto Gómez López, National Polytechnic Institute, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597370
- Sponsor's protocol ID
- CEI-01-2021
- Acronym
- Vaccines COVID
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32941052Pal 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 32337143Arya 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 33245961Bourgonje 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 32418199Zhu 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 31978945Masters 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 14579179Weiss 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 16339739Swelum 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 33102545Contini 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 32235085Majid 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 32864575Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
PubMed 32123347Lu 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 31950516Zhou 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 33199918Park 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 at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity Induced by COVID-19 Vaccines in Mexican Population: mRNA Expression for IgG Anti-spike
- ClinicalTrials.gov ID
- NCT06597370
- Acronym / sponsor ID
- Vaccines COVID / CEI-01-2021
- Conditions
- COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Polytechnic Institute, MexicoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Gene expression mRNA of IgG anti-spike20 persons who have received the Oxford/AstraZeneca vaccine (ChAdOx1 nCoV-19). |
| Group 2 | – | Other: Gene expression mRNA of IgG anti-spike20 persons who have received the vaccine Gamaleya National Center(Sputnik V) |
| Group 3 | – | Other: Gene expression mRNA of IgG anti-spike20 persons who have received the Pfizer/BioNTech vaccine (BNT162b2). |
| Group 4 | – | Other: Gene expression mRNA of IgG anti-spike20 persons who have received the Sinovac (CoronaVac) vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican men and women over 18 years of age, vaccinated in the last 4 months
Key inclusion criteria (6 listed)
- - 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.
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene expression mRNA of IgG anti-spikeb) 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. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Results publication: PubMed 32941052Meyerowitz 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.
- Results publication: PubMed 32337143Pal 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.
- Results publication: PubMed 33245961Arya 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.
- Results publication: PubMed 32418199Bourgonje 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.
- Results publication: PubMed 31978945Zhu 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.
- Results publicationMasters PS, Perlman S. Coronaviridae. 6th ed. Campos virología de, editor. Fields Virology. 2013. 825-58 p.
- Results publication: PubMed 14579179Gonzalez 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.
- Results publication: PubMed 16339739Weiss 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.
- Results publication: PubMed 33102545Swelum 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.
- Results publication: PubMed 32235085Contini 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.
- Results publication: PubMed 32864575Majid 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.
- Results publication: PubMed 32123347Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19 Vaccine
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccine, run by National Polytechnic Institute, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity induced by COVID-19 vaccines in Mexican population (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597370, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.