COVID-19Phase 1/2COVID-19NCT05365724
A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above
A Phase 1/2 study testing Omicron COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by China National Biotec Group Company Limited at 1 site in China.
Trial summary
This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 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?
- Omicron COVID-19 Vaccine (Vero Cell), Inactivated
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Oct 2023
- Phase
- Phase 1/2
- 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 subjects aged 18 years old and above.
- By asking for medical history and physical examination, the investigator judged - that the health condition is well.
- Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
- With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.
Who cannot join
- Confirmed or suspected cases of SARS-CoV-2 Infection.
- Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
- Has received COVID-19 vaccine (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.)
- Axillary body temperature > 37.3 ℃ before vaccination
- Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site inquiry).
- History of hospital-diagnosed thrombocytopenia or other coagulation disorder
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- Known immunological impairment or low level with hospital diagnosis
- History of uncontrolled epilepsy, other progressive neurological disorders, or Guillain-Barre syndrome (self-report, on-site inquiry).
- Known or suspected concomitant serious diseases include: respiratory disease, acute infection or active chronic disease, liver and kidney disease, severe diabetes, malignant tumor, infection or allergic skin disease, HIV infection.
- Severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension, etc.) diagnosed by the hospital, active chronic respiratory disease
- Live attenuated vaccine is inoculated within 1 month before this vaccination
- other vaccines are inoculated within 14 days before this vaccination.
- be participating in or plan to participate in other vaccine clinical trials during this study.
- Contraindications related to vaccination as considered by other investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above With no Vaccination History of COVID-19 Vaccine
This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59 years old and 50 aged 60 years old and above. All subjects will be received 2 doses of Omicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization schedule of 0, 21-28 days. The change in neutralizing antibody level at 28 days after the second dose was used to determine whether to receive a further booster dose for ≥3 months.
The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 and month 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will be analyzed.
- Conditions
- COVID-19
- Being tested
- Omicron COVID-19 Vaccine (Vero Cell), Inactivated
- Keywords
- COVID-19, Omicron, inactivated 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.
Omicron COVID-19 Vaccine (Vero Cell), InactivatedBiological
2 doses of vaccine according to the immunization schedule of 0, 21-28 days
| Study group | Role | What they receive |
|---|---|---|
| subjects aged 18-59 years old | Experimental | Not described Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated |
| subjects aged 60 years old and above | Experimental | Not described Receives: Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 28 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 28 after Dose 2
Incidence of adverse reactions
Measured: within 28 days after vaccination
Secondary outcomes (6)
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 14 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Measured: On Day 14 after Dose 2
The incidence of any adverse reactions/events
Measured: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Measured: From the beginning of the first dose to 12 months after the second immunization
The neutralizing antibody GMT
Measured: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
The proportion of subjects of neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
Measured: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 May 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biological Products Co Ltd., Shulan (Hangzhou) Hospital
- Responsible party
- Sponsor
- Investigators
- Lanjuan Li, Principal investigator, Shulan (Hangzhou) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365724
- Sponsor's protocol ID
- CNBG-BIBP-O-2022003
- Acronym
- COVID-19
- Status last verified
- Jun 2023
- First submitted
- 30 Apr 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above With no Vaccination History of COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05365724
- Acronym / sponsor ID
- COVID-19 / CNBG-BIBP-O-2022003
- Conditions
- COVID-19
- Keywords
- COVID-19, Omicron, inactivated vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (actual)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biological Products Co Ltd., Shulan (Hangzhou) Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 9 May 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 non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59 years old and 50 aged 60 years old and above. All subjects will be received 2 doses of Omicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization schedule of 0, 21-28 days. The change in neutralizing antibody level at 28 days after the second dose was used to determine whether to receive a further booster dose for ≥3 months.
The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 and month 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects aged 18-59 years old | Experimental | Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated |
| subjects aged 60 years old and above | Experimental | Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 18 years old and above.
- By asking for medical history and physical examination, the investigator judged - that the health condition is well.
- Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 12 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
- With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.
Key exclusion criteria (14 listed)
- Confirmed or suspected cases of SARS-CoV-2 Infection.
- Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
- Has received COVID-19 vaccine (include mRNA, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.)
- Axillary body temperature > 37.3 ℃ before vaccination
- Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred (self-report, on-site inquiry).
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 |
|---|---|---|
| Omicron COVID-19 Vaccine (Vero Cell), Inactivated2 doses of vaccine according to the immunization schedule of 0, 21-28 days | Biological | subjects aged 18-59 years old, subjects aged 60 years old and above |
Primary outcome
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after Dose 2
Incidence of adverse reactions
Time frame: within 28 days after vaccination
6 secondary outcomes
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after Dose 2
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Time frame: From the beginning of the first dose to 12 months after the second immunization
The neutralizing antibody GMT
Time frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
The proportion of subjects of neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
Time frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Lanjuan Li principal investigator
Shulan (Hangzhou) Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Omicron COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by China National Biotec Group Company 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 5 inclusion and 14 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 18 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2 (time frame: On Day 28 after Dose 2). 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?
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 18 Jun 2023.