A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)

NCT ID: NCT04758273

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2022-02-28

Brief Summary

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

medium dosage on day 0, 14(18~59 years)

Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14

Group Type: EXPERIMENTAL

medium dosage inactivated SARS-CoV-2 vaccine

Intervention Type: BIOLOGICAL

medium dosage

high dosage on day 0, 14(18~59 years)

Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14

Group Type: EXPERIMENTAL

high dosage inactivated SARS-CoV-2 vaccine

Intervention Type: BIOLOGICAL

high dosage

placebo on day 0, 14(18~59years)

Two doses of placebo on the schedule of day 0,14

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

placebo

medium dosage on day 0, 28, 56(18~59 years)

Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56

Group Type: EXPERIMENTAL

medium dosage inactivated SARS-CoV-2 vaccine

Intervention Type: BIOLOGICAL

medium dosage

high dosage on day 0, 28, 56(18~59 years)

Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56

Group Type: EXPERIMENTAL

high dosage inactivated SARS-CoV-2 vaccine

Intervention Type: BIOLOGICAL

high dosage

placebo on day 0, 28, 56(18~59 years)

Three doses of placebo on the schedule of day 0,28,56

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

placebo

medium dosage on day 0, 28, 56(>59 years)

Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56

Group Type: EXPERIMENTAL

medium dosage inactivated SARS-CoV-2 vaccine

Intervention Type: BIOLOGICAL

medium dosage

high dosage on day 0, 28, 56(>59 years)

Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56

Group Type: EXPERIMENTAL

high dosage inactivated SARS-CoV-2 vaccine

Intervention Type: BIOLOGICAL

high dosage

placebo on day 0, 28, 56(>59 years)

Three doses of placebo on the schedule of day 0,28,56

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

placebo

Interventions

medium dosage inactivated SARS-CoV-2 vaccine

medium dosage

Intervention Type: BIOLOGICAL

high dosage inactivated SARS-CoV-2 vaccine

high dosage

Intervention Type: BIOLOGICAL

Placebo

placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy permanent residents aged 18 years and above;

2. Subjects agree to sign the informed consent forms voluntarily;

3. Subjects are able to comply with the requirements of the clinical trial protocol;

4. Armpit temperature <=37.0 degree C;

5. Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.

Exclusion Criteria

1. Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;

2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);

3. Subjects with history of SARS virus infection by self-reported;

4. Positive in throat swab through RT-PCR;

5. Positive in SARS-CoV-2 antibody test;

6. Subjects with abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration;

7. Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;

8. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history;

9. Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;

10. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >=90 mmHg; subjects aged >=60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;

11. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;

12. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);

13. Subjects receiving anti-TB treatment;

14. Subjects receiving other research drugs within 6 months before vaccination;

15. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);

16. Subjects receiving blood products within 3 months before administration;

17. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;

18. Subjects vaccinated with other vaccine within 7 days before vaccination;

19. The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenzhen Kangtai Biological Products Co., LTD

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: collaborator

Beijing Minhai Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2020L001-1A

Identifier Type: -

Identifier Source: org_study_id