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)

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Biological: Placebo; Biological: medium dosage inactivated SARS-CoV-2 vaccine; Biological: high dosage inactivated SARS-CoV-2 vaccine

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: medium dosage inactivated SARS-CoV-2 vaccine; medium dosage
Experimental: 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	Biological: high dosage inactivated SARS-CoV-2 vaccine; high dosage
Placebo Comparator: placebo on day 0, 14(18~59years); Two doses of placebo on the schedule of day 0,14	Biological: Placebo; placebo
Experimental: medium dosage on day 0, 28(18~59 years); Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28	Biological: medium dosage inactivated SARS-CoV-2 vaccine; medium dosage
Experimental: high dosage on day 0, 28(18~59 years); Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28	Biological: high dosage inactivated SARS-CoV-2 vaccine; high dosage
Placebo Comparator: placebo on day 0, 28(18~59years); Two doses of placebo on the schedule of day 0,28	Biological: Placebo; placebo
Experimental: 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	Biological: medium dosage inactivated SARS-CoV-2 vaccine; medium dosage
Experimental: 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	Biological: high dosage inactivated SARS-CoV-2 vaccine; high dosage
Placebo Comparator: placebo on day 0, 28, 56(18~59 years); Three doses of placebo on the schedule of day 0,28,56	Biological: Placebo; placebo
Experimental: 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	Biological: medium dosage inactivated SARS-CoV-2 vaccine; medium dosage
Experimental: 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	Biological: high dosage inactivated SARS-CoV-2 vaccine; high dosage
Placebo Comparator: placebo on day 0, 28, 56(>59 years); Three doses of placebo on the schedule of day 0,28,56	Biological: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The seropositive rates of SARS-CoV-2 neutralizing antibody	Day 28 post full vaccination
The seropositive level of SARS-CoV-2 neutralizing antibody	Day 28 post full vaccination
The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)	Day 28 post full vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse reactions/events	0-28 days after each dose of vaccination
Serious Adverse Events (SAE)	within 12 months post full vaccination
Level of SARS-CoV-2 IgG antibody (tested by ELISA)	Day 28 post full vaccination
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Minhai Biotechnology Co., Ltd
• Collaborators: Shenzhen Kangtai Biological Products Co., LTD; Jiangsu Province Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2020L001-1B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No