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)

February 16, 2021 updated by: Beijing Minhai Biotechnology Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The seropositive rates of SARS-CoV-2 neutralizing antibody
Time Frame: Day 28 post full vaccination
Day 28 post full vaccination
The seropositive level of SARS-CoV-2 neutralizing antibody
Time Frame: Day 28 post full vaccination
Day 28 post full vaccination
The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)
Time Frame: Day 28 post full vaccination
Day 28 post full vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse reactions/events
Time Frame: 0-28 days after each dose of vaccination
0-28 days after each dose of vaccination
Serious Adverse Events (SAE)
Time Frame: within 12 months post full vaccination
within 12 months post full vaccination
Level of SARS-CoV-2 IgG antibody (tested by ELISA)
Time Frame: Day 28 post full vaccination
Day 28 post full vaccination
The seropositive rates of SARS-CoV-2 neutralizing antibody
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Minhai Biotechnology Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shenzhen Kangtai Biological Products Co., LTD
Jiangsu Province Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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