Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine (COVID-19)

A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia

This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Biological: SARS-CoV-2 vaccine (inactivated); Biological: Placebo

Detailed Description

This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study

Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.

• Study Type: Interventional
• Enrollment (Actual): 1620
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia
      • Hasan Sadikin Hospital/School of Medicine, Padjadjaran University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinically healthy adults aged 18 - 59 years.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial.
3. Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial.
4. Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial.
5. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
6. The result of RT-PCR of swab nasopharyngeal is positive
7. Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test).
8. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
9. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
10. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
11. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
12. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
13. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome
14. Subjects receive any vaccination within 1 month before and after IP immunization.
15. Subjects plan to move from the study area before the end of study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SARS-CoV-2 Vaccine; Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly	Biological: SARS-CoV-2 vaccine (inactivated); SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
Placebo Comparator: Placebo; Participants receive 2 doses of placebo with 14 days interval, intramuscularly	Biological: Placebo; Placebo manufactured by PT. Bio Farma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of laboratory-confirmed COVID-19 after the second dose	Percentage of laboratory-confirmed COVID-19 cases	14 days to 6 months after the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of suspected COVID-19 cases	Percentage of suspected COVID-19 cases	within 14 days to 6 months after the second dose.
Incidence of laboratory-confirmed cases (severe, critical and death)	Percentage of laboratory-confirmed cases (severe, critical, death)	within 14 days to 6 months after the second dose
Seroconversion rate anti-S antibody IgG titer (ELISA)	Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches	14 days after two doses of vaccination
Seroconversion rate anti-S antibody IgG titer (ELISA)	Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches	6 months after two doses of vaccination
Seropositive rate of neutralizing antibodies	Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches	14 days after two doses of vaccination
Seropositive rate of neutralizing antibodies	Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches	6 months after two doses of vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local reaction and systemic events	Number of Local reactions and systemic events	30 minutes to 14 days after each vaccination
Local reaction and systemic events occurring after the last vaccination	Number of Local reactions and systemic events	14 days to 28 days following last vaccination
Serious adverse events during study	Number of any SAE occur	6 months after the last dose

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Sinovac Life Sciences Co., Ltd.; Faculty of Medicine Universitas Padjadjaran; National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia

Publications and helpful links

Helpful Links

• Interim Result

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): January 9, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 8, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; infection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CoV2-0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No