COVID-19Phase 4NCT05165966

Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

A Phase 4 study testing High-dosage of COVID-19 vaccine (Vero cell), Inactivated and Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell)… 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 of COVID-19 vaccine (Vero cell), Inactivated and Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 340 participants
Where: 1 siteChina
Study dates: 20 Oct 2021to 1 Jul 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

Healthy participants aged 18 years and above;
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 COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd and that is currently 5-9 months after the second dose.

Who cannot join

History of SARS-CoV-2 infection(laboratory confirmed);
Have received three and more doses of inactivated COVID-19 vaccine;
Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
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;

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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;
Participated in other clinical trials prior to enrollment and during the followup 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

Beijing Youan Hospital Capital Medical University
Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months

Read the detailed description

This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

Conditions: COVID-19
Being tested: High-dosage of COVID-19 vaccine (Vero cell), Inactivated, Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
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 of COVID-19 vaccine (Vero cell), InactivatedBiological
Also called High-dose CoronaVac®
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Medium-dose COVID-19 Vaccine(Vero Cell),InactivatedBiological
Also called Medium-dose CoronaVac®
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Study groups in NCT05165966
Study group	Role	What they receive
Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated	Experimental	170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated. Receives: Biological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated
Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated	Experimental	170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated. Receives: Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated

What is being measured

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

Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Measured: 14 days after the booster dose vaccination

Secondary outcomes (1)

Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Measured: 14 days after the booster dose vaccination

Timeline

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

20 Oct 20211 Jul 2022

First posted21 Dec 2021
Study start20 Oct 2021
Primary completion20 Apr 2022
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05165966
Sponsor's protocol ID: PRO-nCOV-4010
Status last verified: Dec 2021
First submitted: 20 Dec 2021
Last updated: 11 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months
ClinicalTrials.gov ID: NCT05165966
Acronym / sponsor ID: PRO-nCOV-4010
Conditions: COVID-19
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Oct 2021 (actual)
Primary completion: 20 Apr 2022 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 21 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated	Experimental	Biological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated.
Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated	Experimental	Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy participants aged 18 years and above;
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 COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd and that is currently 5-9 months after the second dose.

Key exclusion criteria (16 listed)

History of SARS-CoV-2 infection(laboratory confirmed);
Have received three and more doses of inactivated COVID-19 vaccine;
Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High-dosage of COVID-19 vaccine (Vero cell), InactivatedAlso: High-dose CoronaVac®High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection	Biological	Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated
Medium-dose COVID-19 Vaccine(Vero Cell),InactivatedAlso: Medium-dose CoronaVac®Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection	Biological	Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated

Primary outcome

Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Time frame: 14 days after the booster dose vaccination
GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination

1 secondary outcome

Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
Time frame: 14 days after the booster dose vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yingmei Feng, Master principal investigator

Beijing YouAn Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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: finished, as of the sponsor's last update on 11 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 14 days after the booster dose 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 NCT05165966.

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 11 Aug 2022.