Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

April 12, 2022 updated by: Sinovac Research and Development Co., Ltd.

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Healthy Population Aged 18 Years and Older

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Study Overview

Status

Status

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

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.

Detailed Description

This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac）in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.

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.
270

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 4

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
    • Shandong
      • Weihai, Shandong, China, 250014
        • Rushan City Center for Disease 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:

  • Healthy population aged 18 years and above;
  • The subjects can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion Criteria:

  • History of SARS-CoV-2 infection;
  • Have received any COVID-19 vaccine;
  • Participants with abnormal fasting blood glucose or diabetes;
  • History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Diseases or factors that are prone to thrombosis or bleeding, such as thrombophlebitis, major surgery/trauma, hereditary thrombotic disorder, sepsis, inflammatory bowel disease, severe varicose veins, May-Thurner syndrome, fibrinolytic activity enhancement disease, history of cardiac stent surgery, allergic purpura, etc.;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • Abnormal hematological laboratory test results outside the reference range during previous physical examination within one year: Blood routine indicators (white blood cell count, hemoglobin, platelet count), Coagulation function test (prothrombin time PT, activated partial prothrombin time APTT, fibrinogen FIB, thrombin time TT, international standardized ratio INR, D-dimer), other indicators (blood glucose, platelet factor 4 HIT ELISA, erythrocyte sedimentation rate);
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
  • History of taking aspirin drugs and other drugs that affect blood coagulation;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the 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: None (Open Label)

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: Experimental Group
180 subjects (including 90 adults aged 18-59 years and 90 elderly aged 60 year and older）will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28
Biological: Inactivated COVID-19 Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Names:
  • CoronaVac
Placebo Comparator: Control Group
90 subjects (including 45 adults aged 18-59 years and 45 elderly aged 60 year and older）will receive one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28
Biological: 23-valent pneumococcal polysaccharide vaccine
25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
Biological: Inactivated Hepatitis A Vaccine
500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.

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
Measure Description
Time Frame
Seroconversion rate of the neutralizing antibody to SARS-CoV-2
Time Frame: Day 28 after the second dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at day 28 after the second dose of inactivated COVID-19 vaccine
Day 28 after the second dose

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
Measure Description
Time Frame
Seroconversion rate of the neutralizing antibody to SARS-CoV-2
Time Frame: Day 4, 14, 32,42 and 56 after the first dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Day 4, 14, 32,42 and 56 after the first dose
Seropositivity rate of the neutralizing antibody to SARS-CoV-2
Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose
Seropositivity rate of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Day 4, 14, 28, 32,42 and 56 after the first dose
GMT of the neutralizing antibody to SARS-CoV-2
Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose
GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Day 4, 14, 28, 32,42 and 56 after the first dose
GMI of the neutralizing antibody to SARS-CoV-2
Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose
GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination
Day 4, 14, 28, 32,42 and 56 after the first dose
Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA)
Time Frame: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA)
Time Frame: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rate of the hepatitis A antibody by Electrochemiluminescence
Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
Seroconversion rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Day 28 after vaccination of Inactivated Hepatitis A Vaccine
Seropositivity rate of the hepatitis A antibody by Electrochemiluminescence
Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
Seropositivity rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Day 28 after vaccination of Inactivated Hepatitis A Vaccine
GMT of the hepatitis A antibody by Electrochemiluminescence
Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
GMT of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Day 28 after vaccination of Inactivated Hepatitis A Vaccine
GMI of the hepatitis A antibody by Electrochemiluminescence
Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine
GMI of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine
Day 28 after vaccination of Inactivated Hepatitis A Vaccine
Occurrence of abnormal changes of laboratory safety examinations
Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose
Occurrence of abnormal changes of laboratory safety examinations (Platelet factor 4 HIT, blood sugar, ESR, White blood cell count, hemoglobin, platelet count and Coagulation function index)
Day 4, 14, 28, 32,42 and 56 after the first dose

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.
Sinovac Research and Development Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Zhang, Master, Shandong Provincial Center 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.
July 9, 2021

Primary Completion (Actual)

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.
October 31, 2021

Study Completion (Actual)

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.
January 31, 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).
July 5, 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.
July 5, 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.
July 7, 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.
April 14, 2022

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.
April 12, 2022

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.
July 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.
  • PRO-nCOV-MA4004-SD

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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