AzTrials
AzTrials

COVID-19Phase 4NCT05079217

Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

A Phase 4 study testing High-dosage SARS-CoV-2 vaccine and Medium-dosage SARS-CoV-2 vaccine in people with COVID-19, run by Sinovac Biotech Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
High-dosage SARS-CoV-2 vaccine and Medium-dosage SARS-CoV-2 vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
17 Dec 2021to 1 Jun 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-59;
  • Proven legal identity;
  • The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
  • Have received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.

Who cannot join

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Have received three and more doses of inactivated SARS-CoV-2 vaccine;
  • Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
  • Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
  • 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;
Show all 17Show fewer
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • 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;
  • Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
  • Axillary temperature >37.0°C;
  • Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
  • Participated in other clinical trials prior to enrollment and during the follow-up period, or planned to participate in other clinical trials during the clinical trial period;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinqi City Center for Disease Control and Prevention

    Xinqi, Jiangsu, 221400

Other trials in China

About this study

Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate Additional Dose of Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine in Healthy Individuals Previously Vaccinated With CoronaVac

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

Read the detailed description

This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .

Conditions
COVID-19
Being tested
High-dosage SARS-CoV-2 vaccine, Medium-dosage SARS-CoV-2 vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-dosage SARS-CoV-2 vaccineBiological

    Also called CoronaVac

    SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

  • Medium-dosage SARS-CoV-2 vaccineBiological

    Also called CoronaVac

    SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Study groups in NCT05079217
Study groupRoleWhat they receive
Experimental GroupExperimental600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .
Receives: Biological: High-dosage SARS-CoV-2 vaccine
Control GroupActive comparator600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
Receives: Biological: Medium-dosage SARS-CoV-2 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）

    GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.

    Measured: Day 28 after booster vaccination

Secondary outcomes (11)

  1. Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）

    The seropositive rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  2. Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）

    The seroconversion rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  3. Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）

    GMI of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  4. Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）

    The seropositive rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  5. Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）

    The seroconversion rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  6. Immunogenicity index-GMI of neutralizing antibodies（Delta Strain）

    GMI of neutralizing antibodies（Delta Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  7. Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain）

    The seroconversion rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  8. Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain）

    The seropositive rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  9. Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain）

    GMI of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  10. Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain）

    GMT of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

  11. Immunogenicity index-GMT of neutralizing antibodies（Delta Strain）

    GMT of neutralizing antibodies（Delta Strain） 28 days after booster vaccination

    Measured: Day 28 after booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start17 Dec 2021
  3. Primary completion21 Dec 2021
  4. Study completion1 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079217
Sponsor's protocol ID
PRO-nCOV-4007
Status last verified
Oct 2021
First submitted
14 Oct 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing High-dosage SARS-CoV-2 vaccine and Medium-dosage SARS-CoV-2 vaccine in people with COVID-19, run by Sinovac Biotech Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain） (time frame: Day 28 after booster vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in