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

NCT05126550 | Unknown

• 1 other identifier: Sinopharm21
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• The proportion of adverse event following immunization

  Within 28 days after 2 doses of vaccination

• The proportion of serious adverse event

  Within 6 months after 2 doses of vaccination

• The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection

  Within 6 months after 2 doses of vaccination

Study Arms (2)

Immunogenicity

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

Non-Immunogenicity

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

Interventions

SARS-CoV-2 vaccine (Vero cell) inactivated BIOLOGICAL

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)

Immunogenicity; Non-Immunogenicity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The recruitment will target potential participants via local company/legal entity/business entity registering for "Vaksinasi Gotong Royong"

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PT. Kimia Farma (Persero) Tbk: lead

Study Sites (4)

Laboratorium Klinik Kimia Farma Diponegoro Bandung

Bandung, Indonesia

Location

Laboratorium Klinik Kimia Farma Cikini

Jakarta, Indonesia

Location

Laboratorium Klinik Kimia Farma Medan

Medan, Indonesia

Location

Laboratorium Klinik Kimia Farma Sutomo Semarang

Semarang, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Internist

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 19, 2021
• Study Start: November 13, 2021
• Primary Completion: November 13, 2022
• Study Completion: November 30, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)