COVID-19Phase 2NCT05293548
A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)
A Phase 2 study testing Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) and Inactivated COVID-19 vaccine (Vero cells) in people with COVID-19, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.
Trial summary
A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group. 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?
- Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) and Inactivated COVID-19 vaccine (Vero cells)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 25 May 2022to Aug 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
- Age: population aged 18 years and above;
- Judged by the investigator that the health condition is well after inquiry and physical examination;
- Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
- Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
- Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;
Who cannot join
- COVID-19 infection positive patients (including suspected or asymptomatic cases);
- Have a history of SARS and MERS infection;
- Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
- Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
- Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
- History of thrombocytopenia or other coagulation disorders;
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- Patients with known immunological impairment or immunocompromised.
- Received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment
- Have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (HIV) infection (test report available);
- Diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (Systolic blood pressure 160 mmHg and/or diastolic blood pressure 95 mmHg).
- Received live attenuated vaccines within 1 month before study enrollment;
- Received inactivated vaccines within 14 days before study enrollment;
- Received other investigational drugs within 6 months before study enrollment;
- Other vaccination-related contraindications considered by investigators.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Sheikh Khalifa Medical City
SEHA, Abu Dhab, 519000
About this study
Official title: A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above
A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09), Inactivated COVID-19 vaccine (Vero cells)
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09)Biological
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) in the deltoid muscle of the upper arm
Inactivated COVID-19 vaccine (Vero cells)Biological
Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| NVSI-06-09 Sequential Immunization Group | Experimental | the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months Receives: Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) |
| Inactivated Vaccine Sequential Immunization Group | Active comparator | the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months Receives: Biological: Inactivated COVID-19 vaccine (Vero cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Measured: 14 days after sequential immunization of one booster dose
the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Measured: 14 days after a single dose of the booster vaccine
The incidence rate of any adverse reactions/events
Measured: within 30 minutes after vaccination
The incidence severity of any adverse reactions/events
Measured: within 30 minutes after vaccination
The incidence rate of solicited adverse reactions/events
Measured: within 0-7 days after vaccination
The incidence severity of solicited adverse reactions/events
Measured: within 0-7 days after vaccination
The incidence rate of solicited adverse reactions/events
Measured: within 8-30 days after vaccination
The incidence severity of solicited adverse reactions/events
Measured: within 8-30 days after immunization
The incidence of SAE observed
Measured: up to 12 months after full course of immunization
The incidence of AESI observed
Measured: up to 12 months after full course of immunization
Secondary outcomes (10)
4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Measured: 28 days after sequential immunization of one booster dose
GMT of anti-omicron neutralizing antibody in adults ≥18 years of age
Measured: 28 days after sequential immunization of one booster dose
4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Measured: 28 days after sequential immunization of one booster dose
GMT of anti-omicron IgG antibody in adults ≥18 years of age
Measured: before booster vaccination and 28 days after a single dose of the booster vaccine
4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age
Measured: before booster vaccination and 28 days after a single dose of the booster vaccine
proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age
Measured: before booster vaccination and 28 days after a single dose of the booster vaccine
GMI of anti-omicron IgG antibody in adults ≥18 years of age
Measured: before booster vaccination and 28 days after a single dose of the booster vaccine
GMTs of anti-omicron neutralizing antibody
Measured: 3 months, 6 months, 9 months and 12 months after sequential immunization
IgG antibody of anti-omicron neutralizing antibody
Measured: 3 months, 6 months, 9 months and 12 months after sequential immunization
the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64
Measured: 3 months, 6 months, 9 months and 12 months after sequential immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start25 May 2022
- Primary completionMay 2023 (estimated)
- Study completionAug 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Vaccine and Serum Institute, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293548
- Sponsor's protocol ID
- CNBG-REC-2022002
- Status last verified
- Jan 2023
- First submitted
- 22 Mar 2022
- Last updated
- 2 Feb 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT05293548
- Acronym / sponsor ID
- CNBG-REC-2022002
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 516 participants (actual)
- Lead sponsor
- National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd, Beijing Institute of Biological Products Co Ltd.
- Study start
- 25 May 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Mar 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.
A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVSI-06-09 Sequential Immunization Group | Experimental | Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09)the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months |
| Inactivated Vaccine Sequential Immunization Group | Active comparator | Biological: Inactivated COVID-19 vaccine (Vero cells)the subjects who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine (Vero cell) for ≥6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: population aged 18 years and above;
- Judged by the investigator that the health condition is well after inquiry and physical examination;
- Vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine (Vero Cell vaccine) 6 months prior to study screening and according to product insert;
- Female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation;
- Be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;
Key exclusion criteria (14 listed)
- COVID-19 infection positive patients (including suspected or asymptomatic cases);
- Have a history of SARS and MERS infection;
- Have been vaccinated by any COVID-19 Vaccines other than Vero Cell vaccine；
- Have an axillary temperature 37.3 (forehead temperature 37.8℃℃);
- Have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of COVID-19 vaccine;
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 |
|---|---|---|
| Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09)Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) in the deltoid muscle of the upper arm | Biological | NVSI-06-09 Sequential Immunization Group |
| Inactivated COVID-19 vaccine (Vero cells)Biological/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm | Biological | Inactivated Vaccine Sequential Immunization Group |
Primary outcome
GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Time frame: 14 days after sequential immunization of one booster dose
the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Time frame: 14 days after a single dose of the booster vaccine
The incidence rate of any adverse reactions/events
Time frame: within 30 minutes after vaccination
The incidence severity of any adverse reactions/events
Time frame: within 30 minutes after vaccination
The incidence rate of solicited adverse reactions/events
Time frame: within 0-7 days after vaccination
The incidence severity of solicited adverse reactions/events
Time frame: within 0-7 days after vaccination
The incidence rate of solicited adverse reactions/events
Time frame: within 8-30 days after vaccination
The incidence severity of solicited adverse reactions/events
Time frame: within 8-30 days after immunization
The incidence of SAE observed
Time frame: up to 12 months after full course of immunization
The incidence of AESI observed
Time frame: up to 12 months after full course of immunization
10 secondary outcomes
4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
Time frame: 28 days after sequential immunization of one booster dose
GMT of anti-omicron neutralizing antibody in adults ≥18 years of age
Time frame: 28 days after sequential immunization of one booster dose
4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
Time frame: 28 days after sequential immunization of one booster dose
GMT of anti-omicron IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
proportions of neutralizing antibody tittered 1: 16, 1: 32 and 1: 64 of anti-SARS-CoV-2 IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
GMI of anti-omicron IgG antibody in adults ≥18 years of age
Time frame: before booster vaccination and 28 days after a single dose of the booster vaccine
GMTs of anti-omicron neutralizing antibody
Time frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
IgG antibody of anti-omicron neutralizing antibody
Time frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64
Time frame: 3 months, 6 months, 9 months and 12 months after sequential immunization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-09) and Inactivated COVID-19 vaccine (Vero cells) in people with COVID-19, run by National Vaccine and Serum Institute, China at 1 site in United Arab Emirates.
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 2 Feb 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 United Arab Emirates. 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?
GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age (time frame: 14 days after sequential immunization of one booster dose). The study lists 10 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 2 Feb 2023.