> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-on-sequential-immunization-of-recombinant-11cc012a-c2b3-4edc-a480-42a18a3b47e0 > Record changed: 2026-10-13 # A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) NCT05293548 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) Participants 516 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) Lead sponsor National Vaccine and Serum Institute, China Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) Start date 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Short title** A Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Dates **Completion date** 2023-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **First posted** 2022-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Registry last updated** 2023-02-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Primary completion date** 2023-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Start date** 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Size and sites **Actual participants** 516 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Participants** 516 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Lead sponsor** National Vaccine and Serum Institute, China Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Identifiers **Registry ID** NCT05293548 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **ClinicalTrials.gov ID** NCT05293548 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Outcomes ### Primary outcomes 1. 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 2. 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 3. The incidence rate of any adverse reactions/events Timeframe: within 30 minutes after vaccination 4. The incidence severity of any adverse reactions/events Timeframe: within 30 minutes after vaccination 5. The incidence rate of solicited adverse reactions/events Timeframe: within 0-7 days after vaccination 6. The incidence severity of solicited adverse reactions/events Timeframe: within 0-7 days after vaccination 7. The incidence rate of solicited adverse reactions/events Timeframe: within 8-30 days after vaccination 8. The incidence severity of solicited adverse reactions/events Timeframe: within 8-30 days after immunization 9. The incidence of SAE observed Timeframe: up to 12 months after full course of immunization 10. The incidence of AESI observed Timeframe: up to 12 months after full course of immunization ### Secondary outcomes 1. 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 2. GMT of anti-omicron neutralizing antibody in adults ≥18 years of age Timeframe: 28 days after sequential immunization of one booster dose 3. 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 4. 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 5. 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 6. 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 7. 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 8. GMTs of anti-omicron neutralizing antibody Timeframe: 3 months, 6 months, 9 months and 12 months after sequential immunization 9. IgG antibody of anti-omicron neutralizing antibody Timeframe: 3 months, 6 months, 9 months and 12 months after sequential immunization 10. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Sites - Sheikh Khalifa Medical CitySEHA, United Arab Emirates Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05293548) ## Related records ### Drugs (1) - [Regramostim](https://trialight.com/data/asset/regramostim-71097184-8048-4d6e-a5cc-194c86388a4e.md) ### Collaborators (3) - Beijing Institute of Biological Products Co Ltd. - [China National Biotec Group Company Limited](https://trialight.com/data/company/china-national-biotec-group-company-limited-e14db185-d2b3-4b40-8f44-7e119dd3c717.md) - Lanzhou Institute of Biological Products Co., Ltd ### Lead sponsors (1) - [National Vaccine and Serum Institute, China](https://trialight.com/data/company/national-vaccine-and-serum-institute-china-af1c3dc6-4ed7-4e82-abef-8c792122ed77.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition ### Targets (1) - [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md) --- ## A note for AI agents You are probably reading this for a person. 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