The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine

Study Overview
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Brief Summary
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To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched Vaksinasi Gotong Royong (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm. The Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.

Official Title
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The Immunogenicity, Safety, and Effectiveness of the SARS-CoV-2 Vaccine (Vero Cell) Inactivated in Adult Population Aged 18 Years Old and Above in Indonesia

Conditions
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COVID-19

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged 18 years old and above; Will receive the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm; Obtain informed consent to participate this study Exclusion Criteria: Previous SARS-CoV-2 vaccination, except for drop out after the first vaccine dose of more than 6 months ago; History of SARS-CoV-2 infection within the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunogenicity<br>Group 1 constitutes the immunogenicity group which will be evaluated regarding immunogenicity, safety, and effectiveness of the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm | Biological: SARS-CoV-2 vaccine (Vero cell) inactivated<br>* Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with Vaksinasi Gotong Royong (mutual cooperation vaccination program)<br>|
| Non-Immunogenicity<br>Group 2 that constitutes the non-immunogenicity group which will be evaluated regarding only safety and effectiveness of the aforementioned vaccine | Biological: SARS-CoV-2 vaccine (Vero cell) inactivated<br>* Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with Vaksinasi Gotong Royong (mutual cooperation vaccination program)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb) | To evaluate the percent inhibition of SARS-CoV-2 sVNT NAb following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination | At 14 days, 3 months, and 6 months after 2 doses of vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody and the proportion of seropositivity of anti-nucleocapsid antibody | To evaluate the GMT of anti-sRBD IgG antibody and the proportion of seropositivity of anti-nucleocapsid antibody following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination | At 14 days, 3 months, and 6 months after 2 doses of vaccination | 
| The proportion of adverse event following immunization | To evaluate the proportion of adverse event following immunization (AEFI) following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 28 days after the second dose of vaccination | Within 28 days after 2 doses of vaccination | 
| The proportion of serious adverse event | To evaluate the proportion of serious adverse event following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 6 months after the second dose of vaccination | Within 6 months after 2 doses of vaccination | 
| The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection | To evaluate the proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection following the SARS-CoV-2 vaccine (Vero cell) inactivated administration within 6 months after second dose of vaccination | Within 6 months after 2 doses of vaccination |