A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05293548
• Other study ID #: CNBG-REC-2022002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 25, 2022
• Est. completion date: August 2023

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 516
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;
• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• 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
• 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

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 Institute 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 efficacy of recombinant COVID-19 vaccine (CHO cell, NVSI-06-09) against COVID-19, severe cases and deaths after 14 days following sequential immunization in adults =18 years of age		During the study,an average of one and a half years
Other	Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults =18 years of age		14 days after a single dose of the booster vaccine
Other	Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults =18 years of age		28 days after a single dose of the booster vaccine
Primary	GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults =18 years of age		14 days after sequential immunization of one booster dose
Primary	the 4-fold rise rate of anti-omicron neutralizing antibody in adults =18 years of age		14 days after a single dose of the booster vaccine
Primary	The incidence rate of any adverse reactions/events		within 30 minutes after vaccination
Primary	The incidence severity of any adverse reactions/events		within 30 minutes after vaccination
Primary	The incidence rate of solicited adverse reactions/events		within 0-7 days after vaccination
Primary	The incidence severity of solicited adverse reactions/events		within 0-7 days after vaccination
Primary	The incidence rate of solicited adverse reactions/events		within 8-30 days after vaccination
Primary	The incidence severity of solicited adverse reactions/events		within 8-30 days after immunization
Primary	The incidence of SAE observed		up to 12 months after full course of immunization
Primary	The incidence of AESI observed		up to 12 months after full course of immunization
Secondary	4-fold rise rate of anti-omicron neutralizing antibody in adults =18 years of age		28 days after sequential immunization of one booster dose
Secondary	GMT of anti-omicron neutralizing antibody in adults =18 years of age		28 days after sequential immunization of one booster dose
Secondary	4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults =18 years of age		28 days after sequential immunization of one booster dose
Secondary	GMT of anti-omicron IgG antibody in adults =18 years of age		before booster vaccination and 28 days after a single dose of the booster vaccine
Secondary	4-fold rise rate of anti-omicron IgG antibody in adults =18 years of age		before booster vaccination and 28 days after a single dose of the booster vaccine
Secondary	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		before booster vaccination and 28 days after a single dose of the booster vaccine
Secondary	GMI of anti-omicron IgG antibody in adults =18 years of age		before booster vaccination and 28 days after a single dose of the booster vaccine
Secondary	GMTs of anti-omicron neutralizing antibody		3 months, 6 months, 9 months and 12 months after sequential immunization
Secondary	IgG antibody of anti-omicron neutralizing antibody		3 months, 6 months, 9 months and 12 months after sequential immunization
Secondary	the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64		3 months, 6 months, 9 months and 12 months after sequential immunization