COVID-19Phase 2NCT05411471
Immunogenicity and Safety Study of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain
A Phase 2 study testing COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in people with COVID-19, run by Sinovac Biotech (Hong Kong) Limited at 1 site in China.
Trial summary
This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA… 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, Omicron Strain
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2022to 25 Jun 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 two or three prior doses of mRNA COVID-19 vaccine (Comirnaty®, made by BioNTech/Pfizer) or CoronaVac®, with the last dose given at least 90 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 the first dose of the booster vaccine in the present study, and are not currently breastfeeding;
- The participants are able to understand and sign the informed consent voluntarily before the first dose of booster vaccine in the present study;
- 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 or vaccination;
- 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 first vaccination in this study;
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- Participation in other studies involving study intervention within 30 days prior to first vaccination in this study;
- Receipt of attenuated live vaccines in the past fourteen days prior to each vaccination in this study;
- Receipt of inactivated or subunit vaccines in the past seven days prior to each 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 >37.5°C on the day of each 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.
About this study
Official title: A Phase IIb, Randomized, Open-labeled Trial to Evaluate the Immunogenicity and Safety of One or Two Doses of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults in Hong Kong
This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.
Read the detailed description
This is a randomized, open-labeled, Phase IIb clinical trial of 300 participants aged 18 years and above, who have completed two or three doses of mRNA vaccine or CoronaVac® in Hong Kong for at least 90 days after the last dose. After enrollment, the participants will be assigned to 2 groups according to their previous vaccination (mRNA vaccine group and CoronaVac® group) and then each group will be randomly assigned to two study arms at a ratio of 1:1 to receive one or two booster doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain.
- Conditions
- COVID-19
- Being tested
- COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain
- 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, Omicron StrainBiological
Also called COVID-19 Omicron Vaccine
The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group) | Experimental | 75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain(1200 SOU). Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain |
| Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group) | Experimental | 75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU). Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain |
| Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group) | Experimental | 75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (1200 SOU). Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain |
| Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group) | Experimental | 75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU). Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean of neutralization antibody titre (GMT)
Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups
Measured: Day 14 after the last booster dose
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 each booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination
Measured: 28 days post booster vaccination
Secondary outcomes (3)
Seroconversion rate of neutralization antibody
Seroconversion rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups
Measured: Day 14 after the last booster dose
Seropositivity rate of neutralization antibody
Seropositivity rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups
Measured: Day 14 after the last booster dose
Occurrence and relationship of SAEs
Occurrence and relationship of SAEs within 6 months post booster vaccination.
Measured: within 6 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.
- First posted9 Jun 2022
- Study start8 Jun 2022
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech (Hong Kong) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan HUNG Fan Ngai, Doctor, Principal investigator, Gleneagles Hospital HongKong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411471
- Sponsor's protocol ID
- PRO-nCOV-2009
- Status last verified
- Sep 2023
- First submitted
- 7 Jun 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Open-labeled Trial to Evaluate the Immunogenicity and Safety of One or Two Doses of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults in Hong Kong
- ClinicalTrials.gov ID
- NCT05411471
- Acronym / sponsor ID
- PRO-nCOV-2009
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Sinovac Biotech (Hong Kong) LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 9 Jun 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.
This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.
Detailed description
This is a randomized, open-labeled, Phase IIb clinical trial of 300 participants aged 18 years and above, who have completed two or three doses of mRNA vaccine or CoronaVac® in Hong Kong for at least 90 days after the last dose. After enrollment, the participants will be assigned to 2 groups according to their previous vaccination (mRNA vaccine group and CoronaVac® group) and then each group will be randomly assigned to two study arms at a ratio of 1:1 to receive one or two booster doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group) | Experimental | Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain(1200 SOU). |
| Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group) | Experimental | Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU). |
| Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group) | Experimental | Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (1200 SOU). |
| Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group) | Experimental | Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adults aged 18 years and above, who have received two or three prior doses of mRNA COVID-19 vaccine (Comirnaty®, made by BioNTech/Pfizer) or CoronaVac®, with the last dose given at least 90 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 the first dose of the booster vaccine in the present study, and are not currently breastfeeding;
- The participants are able to understand and sign the informed consent voluntarily before the first dose of booster vaccine in the present study;
- The participants are willing and able to comply with all schedule visits, sample collection, vaccine plan, and other study procedures;
Key exclusion criteria (12 listed)
- History of confirmed or having evidence showing a current infection of SARS-CoV-2 prior to randomization or vaccination;
- 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;
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 |
|---|---|---|
| COVID-19 Vaccine (Vero Cell), Inactivated, Omicron StrainAlso: COVID-19 Omicron VaccineThe COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL). | Biological | Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group), Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group), Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group), Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group) |
Primary outcome
Geometric mean of neutralization antibody titre (GMT)
Time frame: Day 14 after the last booster dose
Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs
Time frame: 28 days post booster vaccination
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following each booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination
3 secondary outcomes
Seroconversion rate of neutralization antibody
Time frame: Day 14 after the last booster dose
Seropositivity rate of neutralization antibody
Time frame: Day 14 after the last booster dose
Occurrence and relationship of SAEs
Time frame: within 6 months post booster 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 22 Sep 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.
Ivan HUNG Fan Ngai, Doctor principal investigator
Gleneagles Hospital HongKong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in people with COVID-19, run by Sinovac Biotech (Hong Kong) Limited 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: finished, 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 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?
Geometric mean of neutralization antibody titre (GMT) (time frame: Day 14 after the last booster dose). 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?
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.