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COVID-19Phase 4NCT05165732

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

A Phase 4 study testing Experimental vaccine 1, Experimental vaccine 2 and Experimental vaccine 3 in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Experimental vaccine 1, Experimental vaccine 2 and Experimental vaccine 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteChina
Study dates
20 Dec 2022to 20 Aug 2023
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 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 18-45;
  • 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 completed two doses of SARS-CoV-2 inactivated vaccine vaccination for 6 to 8 months(the interval between the two doses vaccine of primary immunization is 21~35 days, and the two doses vaccine of primary immunization should be manufactured by the same manufactures).

Who cannot join

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Have received inactivated SARS-CoV-2 vaccine from other manufacturers other than Sinovac Life Sciences Co., Ltd.,Beijing Institute of Biological Products Co.,Ltd.and Wuhan Institute of Biological Products Co.,Ltd.and 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 19Show 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 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 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

  • Yanhe Tujia Autonomous County Center for Disease Control and Prevention

    Tongren, Guizhou, 565300

Other trials in China

About this study

Official title: A Randomized, Open, Control Phase ⅠV Clinical Trial, to Evaluate One Booster Immunization of Inactivated COVID-19 Vaccine (CoronaVac) or Original Vaccine in Adults Aged 18-45 Years Old Previously Vaccinated With Inactivated COVID-19 Vaccine From Difference Manufactures

This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of SARS-CoV-2 Inactivated Vaccine from different manufactures in adults aged 18-45 years old Previously Vaccinated with inactivated COVID-19 vaccine

Read the detailed description

This study a randomized, Open, control phase Ⅳclinical trial of inactivated COVID-19 vaccine .The purpose of this study is to explore booster Immunization of SARS-CoV-2 inactivated vaccine from different manufactures in adults aged 18-45 years old previously vaccinated with inactivated COVID-19 vaccine.A total of 480 subjects who have completed vaccination of two doses of inactivated COVID-19 vaccine for 6 to 8 months will be enrolled.In this study ,96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd.(experimental group 1).192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will be randomly divided into two groups (experimental group 2 and experimental group 3) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. and Beijing institute of Biological Products Co., Ltd,respectively.192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.will be randomly divided into two groups(experimental group 4 and experimental group 5) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. and Wuhan Institute of Biological Products Co.,Ltd.

Conditions
COVID-19
Being tested
Experimental vaccine 1, Experimental vaccine 2, Experimental vaccine 3
Medical subject headings
COVID-19

What participants receive

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

  • Experimental vaccine 1Biological

    Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.

  • Experimental vaccine 2Biological

    Inactivated COVID-19 vaccine manufactured by Beijing Institute of Biological Products Co.,Ltd.4ug inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.

  • Experimental vaccine 3Biological

    Inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.200WU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.

Study groups in NCT05165732
Study groupRoleWhat they receive
Experimental Group 1Experimental96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd.
Receives: Biological: Experimental vaccine 1
Experimental Group 2Experimental96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd.
Receives: Biological: Experimental vaccine 1
Experimental Group 3Experimental96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd.
Receives: Biological: Experimental vaccine 2
Experimental Group 4Experimental92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd.
Receives: Biological: Experimental vaccine 1
Experimental Group 5Experimental92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.
Receives: Biological: Experimental vaccine 3

What is being measured

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

  1. Immunogenicity index-GMT of neutralizing antibodies

    GMT of neutralizing antibody 28 days after booster dose.

    Measured: 28 days after booster dose

  2. Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies

    Seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose.

    Measured: 28 days after booster dose

  3. Immunogenicity index-seropositive rate of neutralizing antibody

    Seropositive rate of neutralizing antibody 28 days after booster dose.

    Measured: 28 days after booster dose

Secondary outcomes (3)

  1. Safety index-Incidence of adverse reactions

    Incidence of adverse reactions occured 0-28 days after booster

    Measured: 0-28 days after booster

  2. Safety index-Incidence of adverse reactions

    Incidence of adverse reactions occurred 0-7 days after booster dose.

    Measured: 0-7 days after booster dose

  3. Safety index-Incidence of SAEs and AESIs

    Incidence of SAEs and AESIs occured 0-28 days after booster.

    Measured: 0-28 days after booster

Timeline

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

  1. First posted21 Dec 2021
  2. Study start20 Dec 2022 (estimated)
  3. Primary completion20 Mar 2023 (estimated)
  4. Study completion20 Aug 2023 (estimated)

Why it stopped: Limited subjects

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
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165732
Sponsor's protocol ID
PRO-nCOV-4012
Status last verified
Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Experimental vaccine 1, Experimental vaccine 2 and Experimental vaccine 3 in people with COVID-19, run by Sinovac Research and Development 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 19 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: paused, 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?

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 (time frame: 28 days after booster dose). The study lists 3 primary outcomes in all. 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 NCT05165732.

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.

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