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

COVID-19 Clinical Trial

Official title:

Evaluation of the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above: a Randomized, Double-blind, Placebo Parallel-controlled Phase II Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04756323
• Other study ID #: 2020L001-1B
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 27, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2021
• Source: Beijing Minhai Biotechnology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: February 28, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 degrees 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 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;

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

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

9. 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;

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

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

12. Subjects receiving anti-TB treatment;

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

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

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

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

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

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• medium dosage inactivated SARS-CoV-2 vaccine
medium dosage
• high dosage inactivated SARS-CoV-2 vaccine
high dosage
• Placebo
placebo

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Diseases Control and Prevention	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Minhai Biotechnology Co., Ltd	Jiangsu Province Centers for Disease Control and Prevention, Shenzhen Kangtai Biological Products Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The seropositive rates of SARS-CoV-2 neutralizing antibody		Day 28 post full vaccination
Primary	The seropositive level of SARS-CoV-2 neutralizing antibody		Day 28 post full vaccination
Primary	The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)		Day 28 post full vaccination
Secondary	Incidence of adverse reactions/events		0-28 days after each dose of vaccination
Secondary	Serious Adverse Events (SAE)		within 12 months post full vaccination
Secondary	Level of SARS-CoV-2 IgG antibody (tested by ELISA)		Day 28 post full vaccination
Secondary	The seropositive rates of SARS-CoV-2 neutralizing antibody		Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
Secondary	The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)		Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
Secondary	The seropositive level of SARS-CoV-2 neutralizing antibody		Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
Secondary	The seropositive level of SARS-CoV-2 IgG antibody (tested by ELISA)		Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups