COVID-19
Conditions
Keywords
COVID-19
Brief 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.
Interventions
BIOLOGICALRecombinant 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/Vaccine: Inactivated COVID-19 vaccine (Vero cells) Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Sponsors
China National Biotec Group Company Limited
Lanzhou Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co Ltd.
National Vaccine and Serum Institute, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of SAE observed | up to 12 months after full course of immunization |
| The incidence of AESI observed | up to 12 months after full course of immunization |
| GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age | 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 | 14 days after a single dose of the booster vaccine |
| The incidence rate of any adverse reactions/events | within 30 minutes after vaccination |
| The incidence severity of any adverse reactions/events | within 30 minutes after vaccination |
| The incidence rate of solicited adverse reactions/events | within 0-7 days after vaccination |
| The incidence severity of solicited adverse reactions/events | within 0-7 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| GMTs of anti-omicron neutralizing antibody | 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 | 3 months, 6 months, 9 months and 12 months after sequential immunization |
| IgG antibody of anti-omicron neutralizing antibody | 3 months, 6 months, 9 months and 12 months after sequential immunization |
| 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age | 28 days after sequential immunization of one booster dose |
| GMT of anti-omicron neutralizing antibody in adults ≥18 years of age | 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 | 28 days after sequential immunization of one booster dose |
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United Arab Emirates
Outcome results
None listed