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COVID-19Phase 2NCT05254236

Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated Vaccine in Healthy Adults in in Hong Kong

A Phase 2 study testing COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose) and COVID-19 Vaccine (Vero Cell), Inactivated (High-dose) in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized, double-blinded, Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate to evaluate the changes in immunogenicity before and after the booster vaccine using the high (1200 SU) or medium (600 SU)… 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?
COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose) and COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
10 Feb 2022to 10 Mar 2022
Phase
Phase 2
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 adults aged 18 years and above, who have received two prior doses of mRNA COVID-19 vaccine (Comirnaty®, made by BioNTech/Pfizer) as the primary vaccination, with the second dose given at least 180 days prior to the day of booster vaccination in the present study;
  • Evidence of a deep throat saliva (DTS) PCR negative for SARS-COV-2 within 24 hours before enrollment;
  • Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
  • The participants are able to understand and sign the informed consent voluntarily;
  • The participants are willing and able to comply with all schedule visits, sample collection,vaccine plan, and other study procedures;
  • The participants must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

Who cannot join

  • History of confirmed or having evidence showing a current infection of SARS-CoV-2 prior to randomization;
  • Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
  • Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
  • Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc.;
  • Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
  • Receipt of blood/plasma products or immunoglobulins in the past three months before vaccination in this study;
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  • Participation in other studies involving study intervention within 30 days prior to vaccination in this study;
  • Receipt of attenuated live vaccines in the past fourteen days prior to vaccination in this study;
  • Receipt of inactivated or subunit vaccines in the past seven days prior to vaccination in this study;
  • Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma,migraine, gastrointestinal disorder, etc.);
  • Acute febrile illness with oral temperature >37.5C on the day of vaccination;
  • According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gleneagles Hospital HongKong

    Hong Kong

Other trials in China

About this study

Official title: A Phase IIb, Randomized, Double-Blinded Trial to Evaluate the Immunogenicity and Safety Study of the Booster Dose Using the High or Medium Dose of COVID- 19 Vaccine (Vero Cell), Inactivated in Healthy Adults Who Have Completed Two Doses of mRNA Vaccine in Hong Kong

This is a randomized, double-blinded, Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate to evaluate the changes in immunogenicity before and after the booster vaccine using the high (1200 SU) or medium (600 SU) dose of COVID-19 Vaccine (Vero Cell), Inactivated.

Read the detailed description

This is a randomized, double-blinded, Phase IIb clinical trial of 150 participants aged 18 years and above, who have completed two doses of mRNA COVID-19 vaccine as the primary vaccination for at least six months after the second dose. After enrollment, participants will be randomly assigned into two study arms at a ratio of 1:1 to receive a booster of one dose of medium-dose (600 SU) or one dose of high-dose (1200 SU) COVID-19 Vaccine.

Conditions
COVID-19
Being tested
COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose), COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)
Medical subject headings
COVID-19

What participants receive

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

  • COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose)Biological

    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

  • COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)Biological

    High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Study groups in NCT05254236
Study groupRoleWhat they receive
Medium-dose armExperimental75 participants vaccinated two doses of mRNA vaccine(prior to this study) will be given one dose booster immunization using medium-dose COVID-19 Vaccine (Vero Cell), Inactivated
Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose)
High-dose armExperimental75 participants vaccinated two doses of mRNA vaccine(prior to this study) will be given one dose booster immunization using high-dose COVID-19 Vaccine (Vero Cell), Inactivated
Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)

What is being measured

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

  1. Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the high dose

    Geometric mean fold rise (GMFR) of neutralization antibody titre from baseline to 28 days post the booster vaccine in the high dose .

    Measured: 28 days after the booster dose vaccination

  2. Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the medium dose

    Geometric mean fold rise (GMFR) of neutralization antibody titre from baseline to 28 days post the booster vaccine in the medium dose .

    Measured: 28 days after the booster dose vaccination

Secondary outcomes (15)

  1. Immunogenicity index-the seropositivity rate of neutralizing antibody in the high dose

    The seropositivity rate of neutralizing antibody on day 28 after the booster dose vaccination in the high dose

    Measured: 28 days after the booster dose vaccination

  2. Immunogenicity index-the seropositivity rate of neutralizing antibody in the medium dose

    The seropositivity rate of neutralizing antibody on day 28 after the booster dose vaccination in the high dose

    Measured: 28 days after the booster dose vaccination

  3. Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT) in the medium dose

    Geometric mean of neutralizing antibody titer (GMT) on Day 28 after the booster dose vaccination in the high dose

    Measured: 28 days after the booster dose vaccination

  4. Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT)in the medium dose

    Geometric mean of neutralizing antibody titer (GMT) on Day 28 after the booster dose vaccination in the medium dose

    Measured: 28 days after the booster dose vaccination

  5. Immunogenicity index-The seropositivity rate of neutralizing antibody in the high dose

    The seropositivity rate of neutralizing antibody at 3 months after the booster dose vaccination in the high dose

    Measured: 3 months after the booster dose vaccination

  6. Immunogenicity index-The seropositivity rate of neutralizing antibody in the medium dose

    The seropositivity rate of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose

    Measured: 3 months after the booster dose vaccination

  7. Immunogenicity index-The seropositivity rate in the high dose

    The seropositivity rate of neutralizing antibody at 6 months after the booster dose vaccination in the high dose

    Measured: 6 months after the booster dose vaccination

  8. Immunogenicity index-The seropositivity rate in the medium dose

    The seropositivity rate of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose

    Measured: 6 months after the booster dose vaccination

  9. Immunogenicity index-GMT of neutralizing antibody in the high dose

    GMT of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose

    Measured: 3 months after the booster dose vaccination

  10. Immunogenicity index-the GMT of neutralizing antibody in the high dose

    GMT of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose

    Measured: 6 months after the booster dose vaccination

  11. Immunogenicity index-GMT of neutralizing antibody in the medium dose

    GMT of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose

    Measured: 3 months after the booster dose vaccination

  12. Immunogenicity index-the GMT of neutralizing antibody in the medium dose

    GMT of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose

    Measured: 6 months after the booster dose vaccination

  13. Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs

    Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for seven days following the booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination.

    Measured: 28 days after the booster dose vaccination

  14. Safety index-Occurrence and relationship of SAEs

    Occurrence and relationship of SAEs within 12 months post booster vaccination.

    Measured: Within 12 months post booster vaccination

  15. Safety index-Occurrence and relationship of AESI

    Occurrence and relationship of AESI within 12 months post booster vaccination.

    Measured: Within 12 months post 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 posted24 Feb 2022
  2. Study start10 Feb 2022
  3. Primary completion10 Mar 2022
  4. Study completion10 Mar 2022 (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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254236
Sponsor's protocol ID
PRO-nCOV-2004
Status last verified
Sep 2023
First submitted
20 Feb 2022
Last updated
22 Sep 2023
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 2 study testing COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose) and COVID-19 Vaccine (Vero Cell), Inactivated (High-dose) 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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 22 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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-Geometric mean fold rise (GMFR) of neutralization antibody titre in the high dose (time frame: 28 days after the booster dose vaccination). The study lists 2 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 NCT05254236.

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 22 Sep 2023.

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