The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Immunogenicity First 500 participants will be assigned to group 1 that constitute 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
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)
|
| Non-Immunogenicity The next 500 participants will be assigned to group 2 that constitute 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
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)
|
Outcome Measures
Primary Outcome Measures
- The proportion of seropositivity of anti-SARS-CoV-2 neutralizing antibody [At 14 days, 3 months, and 6 months after 2 doses of vaccination]
To evaluate the proportion of seropositivity of anti-SARS-CoV-2 neutralizing antibody following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination
Secondary Outcome Measures
- 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 [At 14 days, 3 months, and 6 months after 2 doses of vaccination]
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
- The proportion of adverse event following immunization [Within 28 days after 2 doses of vaccination]
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
- The proportion of serious adverse event [Within 6 months after 2 doses of vaccination]
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
- The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection [Within 6 months after 2 doses of vaccination]
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
Eligibility Criteria
Criteria
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 History of SARS-CoV-2 infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratorium Klinik Kimia Farma Diponegoro Bandung | Bandung | Indonesia | ||
| 2 | Laboratorium Klinik Kimia Farma Cikini | Jakarta | Indonesia | ||
| 3 | Laboratorium Klinik Kimia Farma Medan | Medan | Indonesia | ||
| 4 | Laboratorium Klinik Kimia Farma Sutomo Semarang | Semarang | Indonesia |
Sponsors and Collaborators
- PT. Kimia Farma (Persero) Tbk
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Sinopharm21