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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069129
• Other study ID #: CNBG-REC-2021003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 14, 2021
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: National Vaccine and Serum Institute, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 4-6 months, 7-9 months and >9 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1848
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• COVID-19 Pneumonia

Intervention

Biological:
• Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm
• Inactivated COVID-19 vaccine (Vero cells)
Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
• 3 doses Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08)
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

Locations

Country	Name	City	State
United Arab Emirates	Sheikh Khalifa Medical City	Seha	Abu Dhab

Sponsors (4)

Lead Sponsor	Collaborator
National Vaccine and Serum Institute, China	Beijing Insitute of Biological Products Co., Ltd, China National Biotec Group Company Limited, Lanzhou Institute of Biological Products Co., Ltd

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths		14th day after vaccination
Other	Anti-SARS-CoV-2 neutralizing antibody		3th month, 6th month, 9th month and 12th month after full course of immunization
Other	Anti-SARS-CoV-2 GMT of IgG antibody		3th month, 6th month, 9th month and 12th month after full course of immunization
Other	Proportion of neutralizing antibody titer = 1: 16, = 1: 32 and = 1: 64		3th month, 6th month, 9th month and 12th month after full course of immunization
Other	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		15th day after full course of immunization
Other	To evaluate the vaccine efficacy of recombinant COVID-19 vaccine (CHO cells,NVSI-06-08) against different variants after sequential vaccination at different schedules	only sequential clinical trial group	15th day after full course of immunization
Primary	The incidence and serverity of any adverse reactions		within 30 minutes after vaccination
Primary	The incidence and serverity of solicited adverse events		within 30 minutes after vaccination
Primary	The incidence and serverity of solicited adverse reactions		within 0-7 days after vaccination
Primary	The incidence and severity of unsolicited adverse reactions		within 0-7 days after vaccination
Primary	The incidence and serverity of solicited adverse reactions		within 8-30 days after vaccination
Primary	The incidence and serverity of solicited adverse events		within 8-30 days after vaccination
Primary	The incidence of SAE observed		after vaccination and up to 6 months after full course of immunization.
Primary	The incidence of AESI observed		after vaccination and up to 6 months after full course of immunization
Primary	GMT of subject's anti- SARS-CoV-2 neutralizing antibody		15th day after vaccination
Primary	GMT of subject's anti- SARS-CoV-2 neutralizing antibody		30th day after vaccination
Primary	Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody		15th day after vaccination
Primary	Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody		30th day after vaccination
Secondary	Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody		before vaccination
Secondary	Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody		30th day after the full course of vaccination
Secondary	Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody		before vaccination
Secondary	Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody		30th day after the full course of vaccination
Secondary	GMI of subject's anti-SARS-CoV-2 IgG antibody		before vaccination
Secondary	GMI of subject's anti-SARS-CoV-2 IgG antibody		30th day after the full course of vaccination
Secondary	Proportion of neutralizing antibody titer = 1: 16, = 1: 32 and = 1: 64		before vaccination
Secondary	Proportion of neutralizing antibody titer = 1: 16, = 1: 32 and = 1: 64		30th day after the full course of vaccination
Secondary	Rate of Anti-SAR-CoR-2 neutralizing antibody	only sequential clinical trial group	the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
Secondary	Rate of GMT of IgG antibody	only sequential clinical trial group	the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
Secondary	Rate of the titer of neutralizing antibody = 1: 16, = 1: 32 and = 1: 64	only sequential clinical trial group	the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
Secondary	Rate of Anti-SAR-CoR-2 neutralizing antibody	only Safety Observation Group	the 6th month, 12th month after the full course of vaccination
Secondary	Rate of GMT of IgG antibody	only Safety Observation Group	the 6th month, 12th month after the full course of vaccination
Secondary	Rate of the titer of neutralizing antibody = 1: 16, = 1: 32 and = 1: 64	only Safety Observation Group	the 6th month, 12th month after the full course of vaccination