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COVID-19Phase 2NCT05150496

Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey

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

Suspended

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

Official record
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Trial summary

This is a randomized, double-blinded, and positive-controlled Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the immunogenicity of using the high (1200SU) or medium (600SU) dose of CoronaVac® as the booster… 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?
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated and High-dose COVID-19 Vaccine(Vero Cell),Inactivated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Dec 2022to 15 Jan 2023
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 2 prior doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty), with the second dose given 3-8 months (for CoronaVac® recipients) and 6-8 months (for Comirnaty recipients) prior to the day of booster vaccination in the present study;
  • Antigen rapid testing negative at the day of enrollment on site or with a PCR negative result within 72 hours before enrollment;
  • The participants are able to understand and sign the informed consent voluntarily;
  • Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
  • The participants are planning to be living in Turkey for the following 1 year after attending this study;
  • 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 currently with the 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 3 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 14 days prior to vaccination in this study;
  • Receipt of inactivated or subunit vaccines in the past 7 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 axillary temperature >37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to 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

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Hacettepe University Faculty of Medicine, Department of Internal Diseases / Infectious Diseases and Clinical Microbiology Unit

    Ankara, 6230

  • Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases

    Ankara, 6800

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase IIb Randomized Double-Blinded Positive Controlled Trial to Evaluate the Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults Who Have Completed Two Doses of CoronaVac® or the mRNA Vaccine (Comirnaty) in Turkey

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

Read the detailed description

This is a randomized, double-blinded, and positive-controlled phaseⅡb clinical trial of 640 participants aged 18 years and above, who have completed 2 doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty) as the primary vaccination. Participants will be enrolled and randomly assigned into two arms at a ratio of 1:1 to receive a booster dose of medium-dose (600SU) or high-dose (1200SU) COVID-19 Vaccine. For those who were vaccinated with CoronaVac®, the booster dose will be given 3-8 months after their second dose. For those who were vaccinated with Comirnaty, the booster dose will be given 6-8 months after their second dose. Each participant will be collected 5.0 ml blood sample before vaccination and 14 days,3 months and 6 months after booster immunization.Immunogenicity assessments will be determined by neutralizing antibodies in all participants.In addition,all participants will be monitored for immediate reactions (within 30 minutes) after the booster dose vaccination, adverse events of special interest (AESIs) and serious adverse events (SAEs) for 12 months after booster dose inoculation. In addition, all participants in will be monitored for local and systemic solicited adverse events (AEs) within 7 days and the unsolicited AEs within 28 days.

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

  • 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

  • High-dose 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

Study groups in NCT05150496
Study groupRoleWhat they receive
Two doses CoronaVac® + one dose medium-dose CoronaVac®Experimental200 participants who were vaccinated with CoronaVac® will be given one dose booster immunization using medium-dose CoronaVac®3-8 months after their second dose
Receives: Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Two doses CoronaVac® + one dose high-dose CoronaVac®Experimental200 participants who were vaccinated with CoronaVac® will be given one dose booster immunization using high-dose CoronaVac® 3-8 months after their second dose
Receives: Biological: High-dose COVID-19 Vaccine(Vero Cell),Inactivated
Two doses Comirnaty + one dose medium-dose CoronaVac®Experimental120 participants were vaccinated with Comirnaty will be given one dose booster immunization using medium-dose CoronaVac® 6-8 months after their second dose
Receives: Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Two doses Comirnaty + one dose high-dose CoronaVac®Experimental120 participants were vaccinated with Comirnaty will be given one dose booster immunization using one dose high-dose CoronaVac® 6-8 months after their second dose
Receives: Biological: High-dose COVID-19 Vaccine(Vero Cell),Inactivated

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 antibodies on 14 days (14-28 days) after the booster dose vaccination

    Measured: 14 days (14-28 days) after the booster dose vaccination

Secondary outcomes (8)

  1. Immunogenicity index-Seropositivity rate of neutralizing antibodies

    Seropositivity rate of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination

    Measured: 14 days (14-28 days) after the booster dose vaccination

  2. Immunogenicity index-GMI of neutralizing antibodies

    GMI of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination

    Measured: 14 days (14-28 days) after the booster dose vaccination

  3. Immunogenicity index-The seropositivity rate of neutralizing antibody

    Seropositivity rate of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination

    Measured: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination

  4. Immunogenicity index-GMT of neutralizing antibody

    GMT of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination

    Measured: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination

  5. 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 7 days following the booster dose vaccination

    Measured: 7 days following the booster dose vaccination

  6. Safety index-Occurrence, intensity, duration, and relationship of unsolicited AEs

    Occurrence, intensity, duration, and relationship of unsolicited AEs for 28 days post booster vaccination

    Measured: 28 days post booster vaccination

  7. Safety index-Occurrence and relationship of SAEs

    Occurrence and relationship of SAEs (from the booster dose to 12 months post booster vaccination)

    Measured: From the booster dose to 12 months post booster vaccination

  8. Safety index-Occurrence and relationship of AESI

    Occurrence and relationship of AESI (from the booster dose to 12 months post booster vaccination)

    Measured: From the booster dose to 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 posted9 Dec 2021
  2. Study start15 Dec 2022 (estimated)
  3. Primary completion15 Jan 2023 (estimated)
  4. Study completion15 Jan 2023 (estimated)

Why it stopped: The plan has changed

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
Double blind
Who is masked
Participant, Investigator
Enrolment
640 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05150496
Sponsor's protocol ID
PRO-nCOV-2002
Status last verified
Nov 2021
First submitted
25 Nov 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 2 study testing Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated and High-dose COVID-19 Vaccine(Vero Cell),Inactivated in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 2 sites in Turkey (Türkiye).

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: 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 2 sites in Turkey (Türkiye). 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?

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: 14 days (14-28 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 NCT05150496.

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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