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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05126550
• Other study ID #: Sinopharm21
• Status: Active, not recruiting
• Start date: November 13, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: September 2022
• Source: PT. Kimia Farma (Persero) Tbk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 435
• Est. completion date: November 30, 2022
• Est. primary completion date: November 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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)

Locations

Country	Name	City	State
Indonesia	Laboratorium Klinik Kimia Farma Diponegoro Bandung	Bandung
Indonesia	Laboratorium Klinik Kimia Farma Cikini	Jakarta
Indonesia	Laboratorium Klinik Kimia Farma Medan	Medan
Indonesia	Laboratorium Klinik Kimia Farma Sutomo Semarang	Semarang

Sponsors (1)

Lead Sponsor	Collaborator
PT. Kimia Farma (Persero) Tbk

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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