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

Active, not recruiting

• Conditions: COVID-19
• Interventions: Biological: SARS-CoV-2 vaccine (Vero cell) inactivated

• Registration Number: NCT05126550
• Lead Sponsor: PT. Kimia Farma (Persero) Tbk

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study Start: 2021-11-13
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-08
• Primary Completion: 2022-11-13
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 435

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Immunogenicity	SARS-CoV-2 vaccine (Vero cell) inactivated	Group 2 that constitutes the non-immunogenicity group which will be evaluated regarding only safety and effectiveness of the aforementioned vaccine
Immunogenicity	SARS-CoV-2 vaccine (Vero cell) inactivated	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

Primary Outcome Measures

Name	Time	Method
The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb)	At 14 days, 3 months, and 6 months after 2 doses of vaccination	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

Secondary Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (4)

Laboratorium Klinik Kimia Farma Cikini; 🇮🇩 Jakarta, Indonesia

Laboratorium Klinik Kimia Farma Sutomo Semarang; 🇮🇩 Semarang, Indonesia

Laboratorium Klinik Kimia Farma Diponegoro Bandung; 🇮🇩 Bandung, Indonesia

Laboratorium Klinik Kimia Farma Medan; 🇮🇩 Medan, Indonesia