Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)
Condition: COVID-19 Virus Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Inactivated SARS-CoV-2 vaccine (Vero cell); Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.; Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical trial conducted in randomized, double-blinded, placebo-controlled design.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2 infection; Inactivated SARS-CoV-2 Vaccine