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

• ClinicalTrials.gov Identifier: NCT04508075
• Recruitment Status: Recruiting
• First Posted: August 11, 2020
• Last Update Posted: August 21, 2020
• Sponsor: PT Bio Farma
• Collaborators: Faculty of Medicine Universitas Padjadjaran; National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia; Sinovac Life Sciences Co., Ltd.
• Information provided by (Responsible Party): PT Bio Farma

Tracking Information

• First Submitted Date: August 7, 2020
• First Posted Date: August 11, 2020
• Last Update Posted Date: August 21, 2020
• Actual Study Start Date: August 10, 2020
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2020)

Incidence of laboratory-confirmed COVID-19 after the second dose [ Time Frame: 14 days to 6 months after the second dose ]

Percentage of laboratory-confirmed COVID-19 cases

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 8, 2020)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 8, 2020)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
• 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
• Brief 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

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
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)

Masking: Double (Participant, Investigator)
Masking Description:

Observer blind Investigational Product and Active Comparator was masking Number of lot was masking

Primary Purpose: Prevention

• Condition: SARS-CoV2 Infection

Intervention

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

Study Arms

• Experimental: SARS-CoV-2 Vaccine
  Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly
  Intervention: Biological: SARS-CoV-2 vaccine (inactivated)
• Placebo Comparator: Placebo
  Participants receive 2 doses of placebo with 14 days interval, intramuscularly
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 8, 2020): 1620
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2021
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Novilia Sjafri Bachtiar, MD, PhD; +6222-2033755 ext 14101; novilia@biofarma.co.id

Contact: Prof. Kusnandi Rusmil, MD, PhD; kusnandi@hotmail.com

• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT04508075
• Other Study ID Numbers: CoV2-0320
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: PT Bio Farma
• Study Sponsor: PT Bio Farma

Collaborators

• Faculty of Medicine Universitas Padjadjaran
• National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia
• Sinovac Life Sciences Co., Ltd.

• Investigators: Not Provided
• PRS Account: PT Bio Farma
• Verification Date: August 2020