COVID-19Phase 4NCT05329038

Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine

A Phase 4 study testing Inactivated COVID-19 Vaccine in people with COVID-19, run by Sinovac Life Sciences 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Inactivated COVID-19 Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteChina
Study dates: 19 Apr 2022to 20 Feb 2024
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

Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
Proven legal identity;

Who cannot join

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;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
Pregnancy or lactation;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days
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

Rushan City Center for Disease Control and Prevention
Weihai, Shandong, 250014

Other trials in China

About this study

Official title: Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of the Third Dose Using Inactivated COVID-19 Vaccine in Population Aged 18 Years and Above

This is a phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.

Read the detailed description

This study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine，to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older. The experimental vaccine is manufactured by Sinovac Life Sciences Co., Ltd.. A total of 180 healthy subjects received two dose of inactivated COVID-19 vaccine (CoronaVac) based on primary immunization in previous Phase Ⅳ clinical trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged 60 years and older.Subjects in each age group will receive the booster immunization of CoronaVac(the third dose) and will be collected blood sample before booster immunization and 14 days after booster immunization.

Conditions: COVID-19
Being tested: Inactivated COVID-19 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.

Inactivated COVID-19 VaccineBiological
Also called CoronaVac
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

Study groups in NCT05329038
Study group	Role	What they receive
Adult group	Experimental	90 subjects aged 18-59 years received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine. Receives: Biological: Inactivated COVID-19 Vaccine
Elderly group	Experimental	90 elderly aged 60 year and older received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine. Receives: Biological: Inactivated COVID-19 Vaccine

What is being measured

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

Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine

Secondary outcomes (10)

Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2
The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMT of neutralizing antibody against Prototype SARS-CoV-2
The GMT of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMI of neutralizing antibody against Prototype SARS-CoV-2
The GMI of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains
The seroconversion rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
Seropositive rate of neutralizing antibody against SARS-CoV-2 strains
The seropositive rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMI of neutralizing antibody against SARS-CoV-2 strains
The GMI of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMT of neutralizing antibody against SARS-CoV-2 strains
The GMT of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Measured: 14 days after the booster immunization of inactivated COVID-19 vaccine
Seropositive rate of antibody against hepatitis A
Seropositive rate of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
Measured: 6-8 months after vaccination of Hepatitis A vaccine
GMC of antibody against hepatitis A
GMC of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
Measured: 6-8 months after vaccination of Hepatitis A vaccine
Incidence rate of adverse reactions
Incidence rate of adverse reactions within 0-28 days after booster immunization with COVID-19 vaccine.
Measured: 0-28 days after booster immunization with COVID-19 vaccine.

Timeline

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

19 Apr 202220 Feb 2024

First posted14 Apr 2022
Study start19 Apr 2022
Primary completion19 Jun 2022
Study completion20 Feb 2024 (estimated)

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: None (open label)
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05329038
Sponsor's protocol ID: PRO-nCOV-MA4009-SD
Status last verified: Nov 2023
First submitted: 12 Apr 2022
Last updated: 7 Nov 2023
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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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of the Third Dose Using Inactivated COVID-19 Vaccine in Population Aged 18 Years and Above
ClinicalTrials.gov ID: NCT05329038
Acronym / sponsor ID: PRO-nCOV-MA4009-SD
Conditions: COVID-19
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 180 participants (estimated)
Lead sponsor: Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Apr 2022 (actual)
Primary completion: 19 Jun 2022 (actual)
Study completion: 20 Feb 2024 (estimated)
First posted: 14 Apr 2022 (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: None (open label)
Number of arms: 2

Arm	Type	Receives
Adult group	Experimental	Biological: Inactivated COVID-19 Vaccine90 subjects aged 18-59 years received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.
Elderly group	Experimental	Biological: Inactivated COVID-19 Vaccine90 elderly aged 60 year and older received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.

Who may qualify

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

Key inclusion criteria (4 listed)

Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
Proven legal identity;

Key exclusion criteria (7 listed)

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;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
Pregnancy or lactation;
Receipt of attenuated live vaccines in the past 14 days;

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
Inactivated COVID-19 VaccineAlso: CoronaVac600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection	Biological	Adult group, Elderly group

Primary outcome

Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.

10 secondary outcomes

Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMT of neutralizing antibody against Prototype SARS-CoV-2
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMI of neutralizing antibody against Prototype SARS-CoV-2
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
Seropositive rate of neutralizing antibody against SARS-CoV-2 strains
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMI of neutralizing antibody against SARS-CoV-2 strains
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
GMT of neutralizing antibody against SARS-CoV-2 strains
Time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
Seropositive rate of antibody against hepatitis A
Time frame: 6-8 months after vaccination of Hepatitis A vaccine
GMC of antibody against hepatitis A
Time frame: 6-8 months after vaccination of Hepatitis A vaccine
Incidence rate of adverse reactions
Time frame: 0-28 days after booster immunization with COVID-19 vaccine.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.

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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.

Li Zhang, Master principal investigator

Shandong Provincial Center for Disease Control and Prevention

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inactivated COVID-19 Vaccine in people with COVID-19, run by Sinovac Life Sciences 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 7 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 7 Nov 2023. 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?

Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 (time frame: 14 days after the booster immunization of inactivated COVID-19 vaccine). 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 NCT05329038.

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 7 Nov 2023.