Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
A Randomized, Controlled Phase I and Sequential Study to Evaluate the Safety and Immunogenicity Following Immunization of GEN2-Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Abu Dhab
-
Seha, Abu Dhab, United Arab Emirates, 519000
- Recruiting
- Sheikh Khalifa Medical City
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age range: populations aged 18 years and above;
- Judged by the investigator that the health condition is well after inquiry and physical examination;
- Vaccinated with 2 doses of CNBG inactivated COVID-19 vaccine according to the product insert(sequential clinical trial group)
- Never vaccinated COVID-19 vaccine(safety observation group);
- Female subjects who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 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; Self has ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.
Exclusion Criteria:
- Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
- With a history of SARS and MERS infection (self-report, on-site inquiry);
- Has vaccinated with any vaccine other than one or more doses of CNBG inactivated COVID-19 vaccine;
- Axillary temperature ≥ 37.3 ℃ (forehead temperature ≥ 37.8 ℃);
- Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of recombinant COVID-19 vaccine;
- Allergic to any component of the study vaccine (e.g. aluminum, histidine, etc.)
- Known or suspected diseases include:Severe respiratory diseases, severe liver and kidney diseases, hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attacks of chronic diseases;
- Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- Has a history of convulsions, epilepsy, encephalopathy,long term history of alcohol and drug abuse, history of thyroidectomy, infectious diseasesor mental illness or family history(lineal);
- With Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
- Has a history of coagulation dysfunction (e.g. coagulation factors deficiency and coagulation diseases);
- Absence of spleen or splenectomy, functional absence of spleen caused by any condition
- Anti -TB (TB) treatment is under way.
- Patients receiving immunoenhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days);
- Received blood products before within 3 months before vaccination;
- Received other investigational drugs within 6 months before vaccination;
- Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit
- Other circumstances judged by investigators that are not suitable for this clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Subject last vaccination time is within 4-6 months(sequential clinical trial group)
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 4-6 months
|
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
|
|
EXPERIMENTAL: Subject last vaccination time is within 7-9 months(sequential clinical trial group)
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days 7-9 months
|
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
|
|
EXPERIMENTAL: Subject last vaccination time more than 9 months(sequential clinical trial group)
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 9 months
|
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
|
|
EXPERIMENTAL: Safety Observation Group
Subject have been vaccinated with three doses of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) on 0,30,60 days
|
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm on 0,30,60 days
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The incidence and severity of unsolicited adverse reactions
Time Frame: within 0-7 days after vaccination
|
within 0-7 days after vaccination
|
|
The incidence and serverity of any adverse reactions
Time Frame: within 30 minutes after vaccination
|
within 30 minutes after vaccination
|
|
The incidence and serverity of solicited adverse events
Time Frame: within 30 minutes after vaccination
|
within 30 minutes after vaccination
|
|
The incidence and serverity of solicited adverse reactions
Time Frame: within 0-7 days after vaccination
|
within 0-7 days after vaccination
|
|
The incidence and serverity of solicited adverse reactions
Time Frame: within 8-30 days after vaccination
|
within 8-30 days after vaccination
|
|
The incidence and serverity of solicited adverse events
Time Frame: within 8-30 days after vaccination
|
within 8-30 days after vaccination
|
|
The incidence of SAE observed
Time Frame: after vaccination and up to 6 months after full course of immunization.
|
after vaccination and up to 6 months after full course of immunization.
|
|
The incidence of AESI observed
Time Frame: after vaccination and up to 6 months after full course of immunization
|
after vaccination and up to 6 months after full course of immunization
|
|
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Time Frame: 15th day after vaccination
|
15th day after vaccination
|
|
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Time Frame: 30th day after vaccination
|
30th day after vaccination
|
|
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time Frame: 15th day after vaccination
|
15th day after vaccination
|
|
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time Frame: 30th day after vaccination
|
30th day after vaccination
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody
Time Frame: before vaccination
|
before vaccination
|
|
|
Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody
Time Frame: 30th day after the full course of vaccination
|
30th day after the full course of vaccination
|
|
|
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time Frame: before vaccination
|
before vaccination
|
|
|
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time Frame: 30th day after the full course of vaccination
|
30th day after the full course of vaccination
|
|
|
GMI of subject's anti-SARS-CoV-2 IgG antibody
Time Frame: before vaccination
|
before vaccination
|
|
|
GMI of subject's anti-SARS-CoV-2 IgG antibody
Time Frame: 30th day after the full course of vaccination
|
30th day after the full course of vaccination
|
|
|
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time Frame: before vaccination
|
before vaccination
|
|
|
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time Frame: 30th day after the full course of vaccination
|
30th day after the full course of vaccination
|
|
|
Rate of Anti-SAR-CoR-2 neutralizing antibody
Time Frame: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
|
only sequential clinical trial group
|
the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
|
|
Rate of GMT of IgG antibody
Time Frame: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
|
only sequential clinical trial group
|
the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
|
|
Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time Frame: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
|
only sequential clinical trial group
|
the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
|
|
Rate of Anti-SAR-CoR-2 neutralizing antibody
Time Frame: the 6th month, 12th month after the full course of vaccination
|
only Safety Observation Group
|
the 6th month, 12th month after the full course of vaccination
|
|
Rate of GMT of IgG antibody
Time Frame: the 6th month, 12th month after the full course of vaccination
|
only Safety Observation Group
|
the 6th month, 12th month after the full course of vaccination
|
|
Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time Frame: the 6th month, 12th month after the full course of vaccination
|
only Safety Observation Group
|
the 6th month, 12th month after the full course of vaccination
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths
Time Frame: 14th day after vaccination
|
14th day after vaccination
|
|
|
Anti-SARS-CoV-2 neutralizing antibody
Time Frame: 3th month, 6th month, 9th month and 12th month after full course of immunization
|
3th month, 6th month, 9th month and 12th month after full course of immunization
|
|
|
Anti-SARS-CoV-2 GMT of IgG antibody
Time Frame: 3th month, 6th month, 9th month and 12th month after full course of immunization
|
3th month, 6th month, 9th month and 12th month after full course of immunization
|
|
|
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time Frame: 3th month, 6th month, 9th month and 12th month after full course of immunization
|
3th month, 6th month, 9th month and 12th month after full course of immunization
|
|
|
The vaccine efficacy of recombinant COVID-19 vaccine (CHO cells,NVSI-06-08) against COVID-19, severe cases and deaths aged 18 years and above
Time Frame: 15th day after full course of immunization
|
15th day after full course of immunization
|
|
|
To evaluate the vaccine efficacy of recombinant COVID-19 vaccine (CHO cells,NVSI-06-08) against different variants after sequential vaccination at different schedules
Time Frame: 15th day after full course of immunization
|
only sequential clinical trial group
|
15th day after full course of immunization
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CNBG-REC-2021003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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