Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)

Study Overview
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Brief Summary
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This study is a randomized, double-blinded, and placebo controlled phase III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18 59 Years.

Detailed Description
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This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18 59 years. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 13.000 subjects will be enrolled. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14. It is planned that the study will be conducted with two separate cohorts. The first cohort will be healthcare workers in the high risk group (K-1) and the second cohort will be people at normal risk (K-2). After 2 doses of vaccination of 1300 volunteers are completed, safety data will be evaluated by the data safety monitoring board without breaking the blinding, and if there is no safety issue, the K2 cohort will continue to be vaccinated.1.300 volunteers, including 650 volunteers SARS-CoV-2 vaccine and placebo arms, will be included in the K-1 cohort. In the K-2 cohort (normal risk group for COVID-19), 7.650 volunteers were planned to be included in the SARS-CoV-2 vaccine group, and 3.500 volunteers in the placebo group.

Official Title
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Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated

Conditions
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COVID-19

Intervention / Treatment
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* Biological: CoronaVac
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-59 years of age (including 18 and 59 years of ages), For only K1 cohort, health care workers such as medical doctor, nurse, ward boy, cleaner, hospital technician, administrative personnel who work in any department of a hospital. Signed informed consent Exclusion Criteria: Previously PCR positive for COVID-19 IgG or IgM is positive For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination Known allergy to components of the study vaccine or control Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study or planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant History of asplenia History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment Received live attenuated virus vaccine 14 days prior to enrollment in the study Inactivated vaccine or sub unit vaccine 7 days prior to enrollment in the study Fever (oral temperature >37.2℃, axillary temperature will not be accepted) within the past 24 hours Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol. Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SARS-COV-2 Vaccine<br>600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart. | Biological: CoronaVac<br>* Two doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14<br>|
| Placebo Comparator: Placebo<br>Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart. | Biological: Placebo<br>* Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19 | The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 | 2 weeks after the second dose of vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protection Indexes of One Vaccine Dose For Symptomatic COVID-19 | The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination. | 2 weeks after the second dose of vaccination | 
| Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death | The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination | 2 weeks after the second dose of vaccination | 
| Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection | The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination | 2 weeks after the second dose of vaccination | 
| Safety indexes of adverse reactions in 28 days | The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination. | 28 days after the second dose of vaccination | 
| Safety indexes of adverse reactions in 7 days | The incidence of adverse reactions within 7 days after each dose of vaccination | 7 days after each dose of vaccination | 
| Safety indexes of serious adverse events in 1 year | The incidence of SAEs from the first vaccination to one year after the second dose vaccination | 1 year after second dose of vaccination | 
| Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days | The seroconversion rate, seropositivity rate 14 days after each dose vaccination | 14 days after each dose vaccination | 
| Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days | The seroconversion rate, seropositive rate 28 days after the second dose vaccination | 28 days after the second dose vaccination | 
| Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days | GMT and GMI of neutralizing antibody and IgG 14 days after each dose vaccination | 14 days after each dose vaccination | 
| Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days | GMT and GMI of neutralizing antibody and IgG 28 days after the second dose vaccination | 28 days after the second dose vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2 Vaccine