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: Unknown
• First Posted: August 12, 2020
• Last Update Posted: February 4, 2022
• 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

Study Description

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

Detailed Description:

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 & D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months

Study Design

• 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
• Actual Primary Completion Date: June 16, 2021
• Estimated Study Completion Date: July 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Investigational Vaccine 1; 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
Experimental: Investigational Vaccine 1b; Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization.	Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell); The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Experimental: Investigational Vaccine 2b; Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization.	Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell); The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
Placebo Comparator: Placebo-b; Participants will receive a booster dose of Placebo after 3 months following two doses of immunization.	Biological: Placebo; The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP

Outcome Measures

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 ]
2. The incidence of COVID-19 cases after the booster dose of immunization [ Time Frame: From 14 days after the booster dose ]

Secondary Outcome Measures :

1. The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination [ Time Frame: From 14 day after the second dose to 6 month after the second dose ]
2. The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination [ Time Frame: From 14 day after the booster dose ]
3. The incidence of any adverse reactions/events [ Time Frame: 28 days after each immunization ]
4. The incidence of serious adverse events (SAE) [ Time Frame: From the beginning of the first dose to 12 months after the second immunization ]
5. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
6. The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
7. The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
8. 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 ]
9. 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 ]
10. 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 ]
11. The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days, 28 days and 6th month after the booster dose ]
12. The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days, 28 days and 6th month after the booster dose ]
13. The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days, 28 days and 6th month after the booster dose ]

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

Bahrain

Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S; Completed

Sanabis, Bahrain

Egypt

Katameya Medical Center; Completed

Cairo, Egypt, 11835

Vacsera health Care facilities , MoH; Completed

Cairo, Egypt, 22311

Jordan

Prince Hamza Hospital; Completed

Amman, Jordan

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; Completed

Sharjah, United Arab Emirates, 61545

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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.

Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):35-45. doi: 10.1001/jama.2021.8565.

• Responsible Party: China National Biotec Group Company Limited
• ClinicalTrials.gov Identifier: NCT04510207
• Other Study ID Numbers: CNBG2020003SQ
• First Posted: August 12, 2020
• Last Update Posted: February 4, 2022
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Vaccines; Immunologic Factors; Physiological Effects of Drugs