Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine

Study Overview
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Brief Summary
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This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

Detailed Description
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This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.

Official Title
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A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Biological: SARS-CoV-2 vaccine (inactivated)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically healthy adults aged 18 - 59 years. Subjects have been informed properly regarding the study and signed the informed consent form. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial. Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another trial. Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial. Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial. Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). The result of RT-PCR of swab nasopharyngeal is positive Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test). Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)). Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome Subjects receive any vaccination within 1 month before and after IP immunization. Subjects plan to move from the study area before the end of study period.

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: Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SARS-CoV-2 Vaccine<br>Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly | Biological: SARS-CoV-2 vaccine (inactivated)<br>* SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac<br>|
| Placebo Comparator: Placebo<br>Participants receive 2 doses of placebo with 14 days interval, intramuscularly | Biological: Placebo<br>* Placebo manufactured by PT. Bio Farma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of laboratory-confirmed COVID-19 after the second dose | Percentage of laboratory-confirmed COVID-19 cases | 14 days to 6 months after the second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of suspected COVID-19 cases | Percentage of suspected COVID-19 cases | within 14 days to 6 months after the second dose. | 
| Incidence of laboratory-confirmed cases (severe, critical and death) | Percentage of laboratory-confirmed cases (severe, critical, death) | within 14 days to 6 months after the second dose | 
| Seroconversion rate anti-S antibody IgG titer (ELISA) | Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches | 14 days after two doses of vaccination | 
| Seroconversion rate anti-S antibody IgG titer (ELISA) | Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches | 6 months after two doses of vaccination | 
| Seropositive rate of neutralizing antibodies | Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches | 14 days after two doses of vaccination | 
| Seropositive rate of neutralizing antibodies | Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches | 6 months after two doses of vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, SARS-CoV-2, infection