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

Sponsor
PT. Kimia Farma (Persero) Tbk (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05126550
Collaborator
(none)
1,000
Enrollment
9.6
Anticipated Duration (Months)

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 DiseaseIntervention/TreatmentPhase
  • Biological: SARS-CoV-2 vaccine (Vero cell) inactivated

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Nov 13, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

ArmIntervention/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

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

No locations specified.

Sponsors and Collaborators

  • PT. Kimia Farma (Persero) Tbk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prenali Dwisthi Sattwika, Principal Investigator, Internist, Gadjah Mada University
ClinicalTrials.gov Identifier:
NCT05126550
Other Study ID Numbers:
  • Sinopharm21
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021