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

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ClinicalTrials.gov Identifier: NCT04508075
Recruitment Status : Active, not recruiting
First Posted : August 11, 2020
Last Update Posted : March 10, 2021
Sponsor:
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

Study Description
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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

Condition or disease Intervention/treatment Phase
SARS-CoV2 Infection Biological: SARS-CoV-2 vaccine (inactivated) Biological: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1620 participants
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
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
Actual Study Start Date : August 10, 2020
Actual Primary Completion Date : January 9, 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of suspected COVID-19 cases [ Time Frame: within 14 days to 6 months after the second dose. ]
    Percentage of suspected COVID-19 cases

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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


Other Outcome Measures:
  1. Local reaction and systemic events [ Time Frame: 30 minutes to 14 days after each vaccination ]
    Number of Local reactions and systemic events

  2. 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

  3. Serious adverse events during study [ Time Frame: 6 months after the last dose ]
    Number of any SAE occur


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508075


Locations
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Indonesia
Hasan Sadikin Hospital/School of Medicine, Padjadjaran University
Bandung, West Java, Indonesia
Sponsors and Collaborators
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.
More Information
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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT04508075    
Other Study ID Numbers: CoV2-0320
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by PT Bio Farma:
vaccine
SARS-CoV-2
infection
Additional relevant MeSH terms:
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Infection