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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510207
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : October 30, 2020
Sponsor:
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

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : March 16, 2021
Estimated Study Completion Date : September 16, 2021

Arm Intervention/treatment
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.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP

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.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP

Placebo Comparator: Placebo
Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21.
Biological: Placebo
The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. The incidence of any adverse reactions/events [ Time Frame: 28 days after each immunization ]
  3. The incidence of serious adverse events (SAE) [ Time Frame: From the beginning of the first dose to 12 months after the second immunization ]
  4. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
  5. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
  6. The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
  7. 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 ]
  8. 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 ]
  9. 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 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT04510207


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

Locations
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Bahrain
Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S Recruiting
Sanabis, Bahrain
Contact: Manaf M Alqahtani, Prof.    +9733966000    drmanaf@gmail.com   
Egypt
Katameya Medical Center Recruiting
Cairo, Egypt, 11835
Contact: Mohamed Hassany, MD    +201128500015    mohamed.hassany@mohealth.gov.eg   
Vacsera health Care facilities , MoH Recruiting
Cairo, Egypt, 22311
Contact: Mohamed Hassany, MD    +201128500015    mohamed.hassany@mohealth.gov.eg   
Jordan
Prince Hamza Hospital Recruiting
Amman, Jordan
Contact: Majed Nusair    +982799501230      
United Arab Emirates
Sheikh Khalifa Medical City, SEHA Recruiting
Abu Dhabi, United Arab Emirates, 51900
Contact: Nawal AI Kaabi, MD    +971505595521    nalkaabi@seha.ae   
Al Qarain Primary Health Care Centre-MOHAP Recruiting
Sharjah, United Arab Emirates, 61545
Contact: Najiba Abdulrazzaq, Doctor    +971506451881    Najiba.Abdulrazzaq@mohap.gov.ae   
Sponsors and Collaborators
China National Biotec Group Company Limited
G42 Healthcare company
Abu Dhabi Health Services Company
Wuhan Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co., Ltd
Investigators
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Study Director: Walid A Zaher, MD, MSc,PhD G42 Healthcare company
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Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT04510207    
Other Study ID Numbers: CNBG2020003SQ
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 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
Keywords provided by China National Biotec Group Company Limited:
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs