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

NCT ID: NCT05069129

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-14
• Study Completion Date: 2024-02-29

Brief 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.

Conditions

COVID-19 Pneumonia; Coronavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Subject last vaccination time is within 4-6 months（sequential clinical trial group）

Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 4-6 months

Group Type: EXPERIMENTAL

Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)

Intervention Type: BIOLOGICAL

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)

Intervention Type: BIOLOGICAL

Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Subject last vaccination time is within 7-9 months（sequential clinical trial group）

Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days 7-9 months

Group Type: EXPERIMENTAL

Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)

Intervention Type: BIOLOGICAL

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)

Intervention Type: BIOLOGICAL

Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Subject last vaccination time more than 9 months（sequential clinical trial group）

Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 9 months

Group Type: EXPERIMENTAL

Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)

Intervention Type: BIOLOGICAL

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)

Intervention Type: BIOLOGICAL

Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Safety Observation Group

Subject have been vaccinated with three doses of Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) on 0，30，60 days

Group Type: EXPERIMENTAL

3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Inactivated COVID-19 vaccine (Vero cells)

Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: collaborator

Lanzhou Institute of Biological Products Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Insitute of Biological Products Co., Ltd

UNKNOWN

Sponsor Role: collaborator

National Vaccine and Serum Institute, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheikh Khalifa Medical City

SEHA, Abu Dhab, United Arab Emirates

Site Status: RECRUITING

Countries

United Arab Emirates

Facility Contacts

Yunkai Yang, Prof.

Role: primary

yangyunkai@sinopharm.com

+8613601126881

References

Kaabi NA, Yang YK, Du LF, Xu K, Shao S, Liang Y, Kang Y, Su JG, Zhang J, Yang T, Hussein S, ElDein MS, Yang SS, Lei W, Gao XJ, Jiang Z, Cong X, Tan Y, Wang H, Li M, Mekki HM, Zaher W, Mahmoud S, Zhang X, Qu C, Liu DY, Zhang J, Yang M, Eltantawy I, Hou JW, Lei ZH, Xiao P, Wang ZN, Yin JL, Mao XY, Zhang J, Qu L, Zhang YT, Yang XM, Wu G, Li QM. Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial. Nat Commun. 2022 Jun 27;13(1):3654. doi: 10.1038/s41467-022-31379-0.

Reference Type: DERIVED

PMID: 35760812 (View on PubMed)

Other Identifiers

CNBG-REC-2021003

Identifier Type: -

Identifier Source: org_study_id