Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)

COVID-19 Virus Infection Clinical Trial

Official title: Randomized, Double Blind, Placebo Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Argentine Healthy Population Aged Between 18 and 85 Years

Status Completed

Clinical Trial Summary

This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.

Clinical Trial Description

SARS-CoV-2 belongs to β Coronavirus family and is a pathogen that can spread across races and is easy to cause respiratory diseases.

In December 2019, patients with pneumonia of unknown causes showed fever, cough, dyspnea, accompanied by medical imaging change of patchy diffuse infiltration of the lungs [2]. Through genome sequencing and analysis of lower respiratory tract alveolar lavage fluid samples from patients with pneumonia of unknown cause, a novel coronavirus different from any known virus was found. The World Health Organization WHO named the virus 2019 novel coronavirus, or 2019-nCoV for short, and the disease caused by the virus was named COVID-19. WHO listed the epidemic as a public health emergency of international concern.

With the spread of the SARS-CoV-2 epidemic in the world, vaccines have become the best weapon for epidemic prevention and control. At present, no vaccine to prevent coronavirus disease (COVID-19) in 2019 has been approved for listing. Based on the experience accumulated in the research and development of coronavirus vaccines in the past, the target of vaccines is also mainly focused on S protein.

Inactivated Virus Vaccine inactivates the virus obtained by culture by heating or chemical methods. The inactivated virus loses its pathogenicity and retains the main antigenic characteristics of the virus capsid, which can stimulate the specific immune response of human body. The inactivated SARS-CoV-2 vaccine (Vero cell) is prepared by inoculating African green monkey kidney cells (Vero cell) with the SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying, and adding aluminum hydroxide adjuvant. After inoculating the vaccine, the recipients can produce immune response to prevent diseases caused by SARS-CoV-2. The inactivated SARS-CoV-2 vaccine (Vero cell) is prepared by inoculating African green monkey kidney cells (Vero cell) with the SARS-CoV-2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying, and adding aluminum hydroxide adjuvant. After inoculating the vaccine, the recipients can produce immune response to prevent diseases caused by SARS-CoV-2. ;

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Virus Infection

• NCT number: NCT04560881
• Study type: Interventional
• Source: Laboratorio Elea Phoenix S.A.
• Status: Completed
• Phase: Phase 3
• Start date: September 16, 2020
• Completion date: December 13, 2021