Clinical trial NCT05126550: The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: PT. Kimia Farma (Persero) Tbk
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 435
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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"

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.


Eligibility 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, 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

Primary outcomes:
measure: The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb)
timeFrame: At 14 days, 3 months, and 6 months after 2 doses of vaccination
Secondary outcomes:
measure: 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
timeFrame: At 14 days, 3 months, and 6 months after 2 doses of vaccination
measure: The proportion of adverse event following immunization
timeFrame: Within 28 days after 2 doses of vaccination
measure: The proportion of serious adverse event
timeFrame: Within 6 months after 2 doses of vaccination
measure: The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection
timeFrame: Within 6 months after 2 doses of vaccination
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Laboratorium Klinik Kimia Farma Diponegoro Bandung
city: Jakarta
country: Indonesia
facility: Laboratorium Klinik Kimia Farma Cikini
city: Medan
country: Indonesia
facility: Laboratorium Klinik Kimia Farma Medan
city: Semarang
country: Indonesia
facility: Laboratorium Klinik Kimia Farma Sutomo Semarang
Study officials:
References: