Clinical trial NCT05293548: A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: National Vaccine and Serum Institute, China
Sponsor class: INDUSTRY
Collaborators: name: China National Biotec Group Company Limited
name: Lanzhou Institute of Biological Products Co., Ltd
name: Beijing Institute of Biological Products Co Ltd.
First posted: 2022-03-24
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
timeFrame: 14 days after sequential immunization of one booster dose
measure: the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
timeFrame: 14 days after a single dose of the booster vaccine
measure: The incidence rate of any adverse reactions/events
timeFrame: within 30 minutes after vaccination
measure: The incidence severity of any adverse reactions/events
timeFrame: within 30 minutes after vaccination
measure: The incidence rate of solicited adverse reactions/events
timeFrame: within 0-7 days after vaccination
measure: The incidence severity of solicited adverse reactions/events
timeFrame: within 0-7 days after vaccination
measure: The incidence rate of solicited adverse reactions/events
timeFrame: within 8-30 days after vaccination
measure: The incidence severity of solicited adverse reactions/events
timeFrame: within 8-30 days after immunization
measure: The incidence of SAE observed
timeFrame: up to 12 months after full course of immunization
measure: The incidence of AESI observed
timeFrame: up to 12 months after full course of immunization
Secondary outcomes:
measure: 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age
timeFrame: 28 days after sequential immunization of one booster dose
measure: GMT of anti-omicron neutralizing antibody in adults ≥18 years of age
timeFrame: 28 days after sequential immunization of one booster dose
measure: 4-fold rise rate of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age
timeFrame: 28 days after sequential immunization of one booster dose
measure: GMT of anti-omicron IgG antibody in adults ≥18 years of age
timeFrame: before booster vaccination and 28 days after a single dose of the booster vaccine
measure: 4-fold rise rate of anti-omicron IgG antibody in adults ≥18 years of age
timeFrame: before booster vaccination and 28 days after a single dose of the booster vaccine
measure: 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
timeFrame: before booster vaccination and 28 days after a single dose of the booster vaccine
measure: GMI of anti-omicron IgG antibody in adults ≥18 years of age
timeFrame: before booster vaccination and 28 days after a single dose of the booster vaccine
measure: GMTs of anti-omicron neutralizing antibody
timeFrame: 3 months, 6 months, 9 months and 12 months after sequential immunization
measure: IgG antibody of anti-omicron neutralizing antibody
timeFrame: 3 months, 6 months, 9 months and 12 months after sequential immunization
measure: the proportions of neutralizing antibody titered 1: 16, 1: 32 and 1: 64
timeFrame: 3 months, 6 months, 9 months and 12 months after sequential immunization
Other outcomes:
measure: 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
timeFrame: During the study，an average of one and a half years
measure: Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age
timeFrame: 14 days after a single dose of the booster vaccine
measure: Cross-protecting effect of neutralizing antibodies against different variants (Alpha, Beta, Delta, and Omicron) in adults ≥18 years of age
timeFrame: 28 days after a single dose of the booster vaccine
Locations:
city: Seha
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
state: Abu Dhab
Study officials:
References: