Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina
ECEHeVac
1 other identifier
interventional
1,760
1 country
4
Brief Summary
Randomized, open, multicenter, collaborative and adaptive non-inferiority trial to evaluate the immunogenicity and reactogenicity of the heterologous vaccination schedules made up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca, Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity of heterologous and homologous vaccination schedules.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2021
Shorter than P25 for phase_2
4 active sites
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
First Submitted
Initial submission to the registry
July 29, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
August 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedSeptember 29, 2021
September 1, 2021
2 months
July 29, 2021
September 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Antibody against Spike protein measurement by ELISA test
To assess IgG anti Spike response (UI/ml): To assess the antibody concentration in each arm by ELISA COVIDAR IgG expressed in IU/ml. To determine whether a heterologous vaccination regimen is non-inferior to that observed with currently used homologous regimens.
28 days
Incidence of adverse events by measurement of the number of reactions after vaccination
Adverse events events presumably attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI)
28 days
Secondary Outcomes (2)
Neutralising Antibody against Spike protein and cellular immune response
6 month
Incidence of adverse events by measurement of the number of reactions after vaccination
6 months
Study Arms (14)
Gam-COVID-Vac C1/ ChAdOx1 nCoV-19
ACTIVE COMPARATORHeterologous: Gam-COVID-Vac C1/ ChAdOx1 nCoV-19
ChAdOx1 nCoV-19 / Gam-COVID-Vac C1
ACTIVE COMPARATORHeterologous: ChAdOx1 nCoV-19 / Gam-COVID-Vac C1
Gam-COVID-Vac C1/ BBIBP-CorV
ACTIVE COMPARATORHeterologous: Gam-COVID-Vac C1/ BBIBP-CorV
BBIBP-CorV / Gam-COVID-Vac C1
ACTIVE COMPARATORHeterologous: BBIBP-CorV / Gam-COVID-Vac C1
ChAdOx1 nCoV-19 / BBIBP-CorV
ACTIVE COMPARATORHeterologous: ChAdOx1 nCoV-19 / BBIBP-CorV
BBIBP-CorV / ChAdOx1 nCoV-19
ACTIVE COMPARATORHeterologous: BBIBP-CorV / ChAdOx1 nCoV-19
Gam-COVID-Vac C1/ mRNA-1273
ACTIVE COMPARATORHeterologous: Gam-COVID-Vac C1/ mRNA-1273
ChAdOx1 nCoV-19 / mRNA-1273
ACTIVE COMPARATORHeterologous: ChAdOx1 nCoV-19 / mRNA-1273
BBIBP-CorV / mRNA-1273
ACTIVE COMPARATORHeterologous BBIBP-CorV / mRNA-1273
Gam-COVID-Vac C1/ Gam-COVID-Vac C2
ACTIVE COMPARATORHomologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C2
ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19
ACTIVE COMPARATORHomologous: ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19
BBIBP-CorV / BBIBP-CorV
ACTIVE COMPARATORHomologous: BBIBP-CorV / BBIBP-CorV
mRNA-1273 / mRNA-1273
ACTIVE COMPARATORHomologous: mRNA-1273 / mRNA-1273
Gam-COVID-Vac C1/ Gam-COVID-Vac C1
ACTIVE COMPARATORHomologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C1
Interventions
Gam-COVID-Vac Gamaleya National Center for Epidemiology and Microbiology - Russia. Non-replicative viral vector. Multi-dose vial (5 doses in 3 mL) Single-dose vial (1 dose in 0.5 mL). Intramuscular T° less than -18 ° C BBIBP-CorV Beijing Institute of Biological Products - People's Republic of China. Inactivated viruses. Single-dose vials (1 dose in 0.5 mL) or multi-dose vial (2 doses per vial). Intramuscular T° 2 to 8 ° C ChAdOx1 nCoV-19 vaccine AZD1222 AstraZeneca-Oxford - United Kingdom. Non-replicative viral vector. Multi-dose vial (10 doses in 5 mL). Intramuscular T°: 2 to 8 ° C mRNA-1273 or Spikevax Moderna Switzerland GmbH and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States. mRNA. Multi-dose vial (maximum 15 doses per 0.5ml vial). Intramuscular. T°-15 ° to -50 °
Eligibility Criteria
You may qualify if:
- years of age or older, vaccinated with 1 dose of Sputnik V, AstraZeneca or Sinopharm vaccine up to 60 days prior to enrollment (according to the platform of the vaccine received as the first dose) or not vaccinated for the mRNA-1273 / mRNA-1273 Arm
- With and without identified risk factors for COVID-19
- Signature of the informed consent
- Remain in the jurisdiction where your study began until the end of it
- Be able to understand and sign the informed consent
You may not qualify if:
- Patients with immunocompromise due to underlying disease or immunosuppressive treatment
- Pregnant and breastfeeding people
- Being registered in the National Health Surveillance System for having suffered COVID-19 (symptomatic or asymptomatic) or having a positive IgG result in nucleocapsid ELISA in the sample taken on "DAY 0" for people who had received Sputnik-V or AstraZeneca as the first dose
- Having had a severe allergic reaction (anaphylaxis) to any vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Córdoba
Córdoba, Argentina
Provincia de Buenos Aires
La Plata, Argentina
La Rioja
La Rioja, Argentina
San Luis
San Luis, Argentina
Related Publications (1)
Nunez NG, Schmid J, Power L, Alberti C, Krishnarajah S, Kreutmair S, Unger S, Blanco S, Konigheim B, Marin C, Onofrio L, Kienzler JC, Costa-Pereira S, Ingelfinger F; InmunoCovidCba; InViV working group; Pasinovich ME, Castelli JM, Vizzotti C, Schaefer M, Villar-Vesga J, Mundt S, Merten CH, Sethi A, Wertheimer T, Lutz M, Vanoaica D, Sotomayor C, Gruppi A, Munz C, Cardozo D, Barbas G, Lopez L, Carreno P, Castro G, Raboy E, Gallego S, Moron G, Cervi L, Acosta Rodriguez EV, Maletto BA, Maccioni M, Becher B. High-dimensional analysis of 16 SARS-CoV-2 vaccine combinations reveals lymphocyte signatures correlating with immunogenicity. Nat Immunol. 2023 Jun;24(6):941-954. doi: 10.1038/s41590-023-01499-w. Epub 2023 Apr 24.
PMID: 37095378DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Pasinovich, MD
Ministry of Public Health, Argentina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical adviser on immunizations, Undersecretary of Health Strategies
Study Record Dates
First Submitted
July 29, 2021
First Posted
August 3, 2021
Study Start
August 3, 2021
Primary Completion
September 30, 2021
Study Completion
February 15, 2022
Last Updated
September 29, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share