Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine

SARS-CoV2 Infection Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508075
• Other study ID #: CoV2-0320
• Status: Completed
• Phase: Phase 3
• Start date: August 10, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2021
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1620
• Est. completion date: August 31, 2021
• Est. primary completion date: January 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

Biological:
• SARS-CoV-2 vaccine (inactivated)
SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
• Placebo
Placebo manufactured by PT. Bio Farma

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin Hospital/School of Medicine, Padjadjaran University	Bandung	West Java

Sponsors (4)

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

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local reaction and systemic events	Number of Local reactions and systemic events	30 minutes to 14 days after each vaccination
Other	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
Other	Serious adverse events during study	Number of any SAE occur	6 months after the last dose
Primary	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	Incidence of suspected COVID-19 cases	Percentage of suspected COVID-19 cases	within 14 days to 6 months after the second dose.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Interim Result