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Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina (ECEHeVac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04988048
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
Russian Direct Investment Fund
Information provided by (Responsible Party):
Marina Pasinovich, md, Ministry of Public Health, Argentina

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
COVID-19 VACCINE Covid19 Biological: COVID-19 vaccines Phase 2

Detailed Description:

More than a hundred COVID-19 vaccines based on different technologies are currentlyin the clinical phase of development around the world. More than a dozen derived from different platforms have been approved by regulatory entities in several countries and are used to immunize the world's population.

The dynamics of the COVID-19 pandemic, the emergence of variants, the magnitude and durability of the immune response, the effectiveness of approved vaccination schemes, as well as the possibility of combining vaccines from various platforms, are some of the issues to be facedin public health decision-making, in order to deliver the best protection standards to the population.

Given the dynamics of the disease in Argentina, the access to different COVID-19 vaccination alternatives requires the development of various strategies, such as stratifying the population sampled by the risk of being infected or transmitting the disease, the agreement for the acquisition of vaccines produced by multiple laboratories simultaneously, setting as a priority first dose vaccination to a higher number of people in a shorter period of time and completing the schemes already started.

The pandemic has revealed the capacity of our country to carry out research studies that produce evidence to face the new challenges posed by COVID19 and, particularly,to implement vaccination as one of the main tools to reduce the health impact it generates-for example,six months after the start of the vaccination campaign, results demonstrate the positive impact of this strategy and its effectiveness.

Models based on heterologous immunization schemes with vaccines from different platforms require evaluation by means of clinical trials,in order to show whether they are not less effective than homologous schemes already established. This is achieved through comparative evaluation of their immunogenicity, efficacy and reactogenicity with studies considering implementation possibilities, adaptiveness and response to real life situations.

Hence, the Ministry of Health propoundsthe development of a collaborative network for the integration of studies on vaccination strategies against COVID-19 with the use of heterologous schemes based on the evaluation of their non-inferiority, compared to homologous vaccination schedulesalready implemented worldwide.

The Argentine Ministry of Health looks forward to generating solid scientific evidence that supports decision-making in health policies, with broad federal participation and common objectives.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open, multicenter, collaborative and adaptive non-inferiority trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Collaborative Study to Evaluate Heterologous Vaccination Against Covid-19 in Argentina
Actual Study Start Date : August 3, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Gam-COVID-Vac C1/ ChAdOx1 nCoV-19
Heterologous: Gam-COVID-Vac C1/ ChAdOx1 nCoV-19
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: ChAdOx1 nCoV-19 / Gam-COVID-Vac C1
Heterologous: ChAdOx1 nCoV-19 / Gam-COVID-Vac C1
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: Gam-COVID-Vac C1/ BBIBP-CorV
Heterologous: Gam-COVID-Vac C1/ BBIBP-CorV
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: BBIBP-CorV / Gam-COVID-Vac C1
Heterologous: BBIBP-CorV / Gam-COVID-Vac C1
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: ChAdOx1 nCoV-19 / BBIBP-CorV
Heterologous: ChAdOx1 nCoV-19 / BBIBP-CorV
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: BBIBP-CorV / ChAdOx1 nCoV-19
Heterologous: BBIBP-CorV / ChAdOx1 nCoV-19
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: Gam-COVID-Vac C1/ mRNA-1273
Heterologous: Gam-COVID-Vac C1/ mRNA-1273
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: ChAdOx1 nCoV-19 / mRNA-1273
Heterologous: ChAdOx1 nCoV-19 / mRNA-1273
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: BBIBP-CorV / mRNA-1273
Heterologous BBIBP-CorV / mRNA-1273
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: Gam-COVID-Vac C1/ Gam-COVID-Vac C2
Homologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C2
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19
Homologous: ChAdOx1 nCoV-19 / ChAdOx1 nCoV-19
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: BBIBP-CorV / BBIBP-CorV
Homologous: BBIBP-CorV / BBIBP-CorV
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: mRNA-1273 / mRNA-1273
Homologous: mRNA-1273 / mRNA-1273
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)
Active Comparator: Gam-COVID-Vac C1/ Gam-COVID-Vac C1
Homologous: Gam-COVID-Vac C1/ Gam-COVID-Vac C1
 Biological: COVID-19 vaccines

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 °

Other Names:
  • SPUTNIK-V (Gam-COVID-Vac)
  • SINOPHARM (BBIBP-CorV)
  • AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222)
  • Moderna (mRNA-1273 or Spikevax)


Outcome Measures
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Primary Outcome Measures :
  1. Antibody against Spike protein measurement by ELISA test [ Time Frame: 28 days ]
    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.

  2. Incidence of adverse events by measurement of the number of reactions after vaccination [ Time Frame: 28 days ]
    Adverse events events presumably attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI)


Secondary Outcome Measures :
  1. Neutralising Antibody against Spike protein and cellular immune response [ Time Frame: 6 month ]
    Neutralizing antibody titer in the serum of vaccinated individuals, using "Vero" cells as infection targets and cellular immune response It will be studied in heparinized blood samples using mononuclear cells isolated from the blood samples obtained. These cells will be challenged "in vitro" with "pools" of peptides from the Spike and N proteins of SARS-CoV-2, evaluating the production of the cytokines interferon-γ and IL-2 by T cells, by flow cytometry.

  2. Incidence of adverse events by measurement of the number of reactions after vaccination [ Time Frame: 6 months ]
    adverse events events presumably attributable to vaccination and immunization (ESAVI) and adverse events of special interest (AESI)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04988048


Contacts
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Contact: Marina Pasinovich, MD +5491154961973 mpasinovich@msal.gov.ar
Contact: Juan Manuel Castelli, MD +5492214088284 jcastelli@msal.gov.ar

Locations
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Argentina
Córdoba Recruiting
Córdoba, Argentina
Contact: Gabriela Barbás         
Provincia de Buenos Aires Recruiting
La Plata, Argentina
Contact: Marina Pifano         
La Rioja Recruiting
La Rioja, Argentina
Contact: Carlos Laino         
San Luis Recruiting
San Luis, Argentina
Contact: Juan Manuel Talia         
Sponsors and Collaborators
Ministry of Public Health, Argentina
Russian Direct Investment Fund
Investigators
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Principal Investigator: Marina Pasinovich, MD Ministry of Public Health, Argentina
More Information
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Responsible Party: Marina Pasinovich, md, Medical adviser on immunizations, Undersecretary of Health Strategies, Ministry of Public Health, Argentina
ClinicalTrials.gov Identifier: NCT04988048    
Other Study ID Numbers: 0001/2021
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marina Pasinovich, md, Ministry of Public Health, Argentina:
Interchangeability
Heterologous vaccination
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs