Randomized, open, multicenter, collaborative and adaptive non-inferiority trial toevaluate the immunogenicity and reactogenicity of the heterologous vaccination schedulesmade up of the combination of vaccines available in Argentina (Sputnik-V, AstraZeneca,Sinopharm and Moderna); and to compare the immunogenicity and reactogenicity ofheterologous and homologous vaccination schedules.
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.
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 Name: SPUTNIK-V (Gam-COVID-Vac),SINOPHARM (BBIBP-CorV),AstraZeneca (ChAdOx1 nCoV-19 vaccine AZD1222),Moderna (mRNA-1273 or Spikevax)
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
Córdoba
Córdoba, Argentina
Provincia de Buenos Aires
La Plata, Argentina
La Rioja
La Rioja, Argentina
San Luis
San Luis, Argentina
Marina Pasinovich, MD
+5491154961973
mpasinovich@msal.gov.ar
Juan Manuel Castelli, MD
+5492214088284
jcastelli@msal.gov.ar
Marina Pasinovich, MD, Principal Investigator
Ministry of Public Health, Argentina