A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above (COVID-19)

• ClinicalTrials.gov Identifier: NCT04510207
• Recruitment Status: Recruiting
• First Posted: August 12, 2020
• Last Update Posted: October 30, 2020
• Sponsor: China National Biotec Group Company Limited
• Collaborators: G42 Healthcare company; Abu Dhabi Health Services Company; Wuhan Institute of Biological Products Co., Ltd; Beijing Institute of Biological Products Co., Ltd
• Information provided by (Responsible Party): China National Biotec Group Company Limited

Tracking Information

• First Submitted Date: August 3, 2020
• First Posted Date: August 12, 2020
• Last Update Posted Date: October 30, 2020
• Actual Study Start Date: July 16, 2020
• Estimated Primary Completion Date: March 16, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 10, 2020): The incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: From14 days after the second dose to 6 month after the second dose ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 10, 2020)

• The incidence of severe cases of SARS-CoV-2 pneumonia and deaths accompanied by COVID-19 after two-doses of vaccination [ Time Frame: From14 day after the second dose to 6 month after the second dose ]
• The incidence of any adverse reactions/events [ Time Frame: 28 days after each immunization ]
• The incidence of serious adverse events (SAE) [ Time Frame: From the beginning of the first dose to 12 months after the second immunization ]
• The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
• The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
• The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
• The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization ]
• The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization ]
• The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization ]

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 10, 2020)

• the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19 [ Time Frame: 14 days after 2 doses of vaccination ]
• The occurrence of ADE [ Time Frame: From the beginning of the first dose to 12 months after the second immunization ]

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

Descriptive Information

• Brief Title: A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
• Official Title: Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
• Brief Summary: This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
  The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
• Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
  The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
• Biological: Placebo
  The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP

Study Arms

• Experimental: Investigational Vaccine1
  Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 & D21.
  Intervention: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
• Experimental: Investigational Vaccine 2
  Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 & D21.
  Intervention: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
• Placebo Comparator: Placebo
  Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21.
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 10, 2020): 45000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 16, 2021
• Estimated Primary Completion Date: March 16, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Healthy subjects aged 18 years old and above.
2. By asking for medical history and physical examination, the investigator judged that the health condition is well.
3. Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
4. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
5. With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

1. Confirmed acute cases of SARS-CoV-2 Infection.
2. Have a history of SARS, MERS infection (self-report, on-site inquiry).
3. Positive urine pregnancy test result.
4. Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
5. Axillary body temperature > 37.0 ℃ before vaccination.
6. Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
7. Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
8. With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
9. With severe liver diseases, severe kidney diseases defined as eGFR less than 60, uncontrollable hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
10. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
11. With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
12. Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
13. Receiving anti-TB therapy.
14. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
15. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
16. Received blood products within 3 months before this vaccination
17. Received other research drugs within 6 months before this vaccination.
18. Other circumstances judged by investigators that are not suitable for this clinical trial.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Yunkai Yang, Prof.; +8613601126881; yangyunkai@sinopharm.com

• Listed Location Countries: Bahrain, Egypt, Jordan, United Arab Emirates

Administrative Information

• NCT Number: NCT04510207
• Other Study ID Numbers: CNBG2020003SQ
• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: China National Biotec Group Company Limited
• Study Sponsor: China National Biotec Group Company Limited

Collaborators

• G42 Healthcare company
• Abu Dhabi Health Services Company
• Wuhan Institute of Biological Products Co., Ltd
• Beijing Institute of Biological Products Co., Ltd

Investigators

• Study Director: Walid A Zaher, MD, MSc,PhD; G42 Healthcare company

• PRS Account: China National Biotec Group Company Limited
• Verification Date: October 2020