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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
3,000
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.
Fundación Huésped
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Vacunar Liniers
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Vacunar Cañitas
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Vacunar Coghlan
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Incidence of COVID-19 cases after two-doses of vaccination
All confirmed COVID -19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.
Time frame: 14 days after the full course of vaccination
The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after 2-dose of immunization and 28 days after full course of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after 2-dose of immunization and 28 days after full course of immunization
The Geometric Mean Increase (GMI) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after 2-dose of immunization and 28 days after full course of immunization
Incidence of any adverse reactions/events
Time frame: Within 30 minutes after each dose of vaccine
Incidence of adverse reactions/events
Time frame: 0 ~ 21/28 days after each dose of vaccine
Incidence of serious adverse events (SAE)
Time frame: From the beginning of the first dose to 12 months after the whole course of immunization
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