NCT05228912

Brief Summary

Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-COV2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI. Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers are being measured at baseline, 21-28 days after the first and second dose (when applicable), six months and a year of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models will be performed for the analyses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,870

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

February 4, 2022

Last Update Submit

February 27, 2023

Conditions

Vaccine Adverse ReactionCOVID-19Vaccine Reaction

Keywords

COVID-19immune responseAdverse reaction

Outcome Measures

Primary Outcomes (1)

  • Seroconversion after first and second dose of SARS-COV2 vaccines

    seroconversion after the first and second dose (if applicable) between BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac, and Coronavac through the measurement of SARS-CoV-2 spike 1-2 IgG antibodies using the same standardized assay

    six months

Secondary Outcomes (1)

  • Adverse reaction after first and second dose of SARS-COV-2 vaccines

    6 months

Other Outcomes (2)

  • Seroconversion after third and fourth dose of SARS-Cov-2 vaccines

    6 months

  • Adverse reaction after third and fourth dose of SARS-COV-2 vaccines

    6 months

Study Arms (7)

BNT162b2 mRNA

Group of patients of any age, any sex, that will receive a complete scheme of approved BNT162b2 mRNA vaccination , assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

mRNA-1273

Group of patients of any age, any sex, that will receive a complete scheme of approved mRNA-1273 vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

ChAdOx1-S

Group of patients of any age, any sex, that will receive a complete scheme of approved ChAdOx1-S vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

Ad26.COV2

Group of patients of any age, any sex, that will receive a complete scheme of approved Ad26.COV2 vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

Ad5-nCoV

Group of patients of any age, any sex, that will receive a complete scheme of approved Ad5-nCoV vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

Gam-COVID-Vac

Group of patients of any age, any sex, that will receive a complete scheme of approved Gam-COVID-Vac vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

Coronavac

Group of patients of any age, any sex, that will receive a complete scheme of approved Coronavac vaccination, assigned by a local government vaccination campaign. It can also include patients that receive a third or fourth boost.

Drug: COVID-19 Vaccines

Interventions

COVID-19 VaccinesDRUG

Each group will receive a complete scheme of the vaccine according to local government assignation

Ad26.COV2Ad5-nCoVBNT162b2 mRNAChAdOx1-SCoronavacGam-COVID-VacmRNA-1273

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include participants of both genders any age, that plan to receive a complete scheme of any of the next vaccines: BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac, or Coronavac. From specified vaccination centres in Mexico, Brazil, Italy and Argentina

You may qualify if:

  • Participants of both genders at relevant vaccination places who consented to participate, planned to conclude the immunization regimen of any vaccine and agree to be followed-up for the duration of the study

You may not qualify if:

  • Previously given any SARS-CoV-2 vaccine prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinica Nova de Monterrey

San Nicolás de los Garza, 66450, Mexico

Location

Related Publications (1)

  • Romero-Ibarguengoitia ME, Gonzalez-Cantu A, Pozzi C, Levi R, Mollura M, Sarti R, Sanz-Sanchez MA, Rivera-Salinas D, Hernandez-Ruiz YG, Armendariz-Vazquez AG, Del Rio-Parra GF, Barco-Flores IA, Gonzalez-Facio R, Azzolini E, Barbieri R, de Azevedo Dias AR, Henriques Guimaraes Junior M, Bastos-Borges A, Acciardi C, Paez-Bo G, Teixeira MM, Rescigno M. Analysis of immunization time, amplitude, and adverse events of seven different vaccines against SARS-CoV-2 across four different countries. Front Immunol. 2022 Jul 28;13:894277. doi: 10.3389/fimmu.2022.894277. eCollection 2022.

    PMID: 35967368DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples to determine the amount of specific anti-S1 and anti-S2 IgG antibodies against SARS-CoV-2 in

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Maria Elena Romero-Ibarguengoitia, MD, MS, PHD

    Hospital Clinica Nova de Monterrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MS, PHD

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 8, 2022

Study Start

February 26, 2021

Primary Completion

October 1, 2022

Study Completion

October 30, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

upon request

Locations

ME(1)