Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

Sponsor
National Vaccine and Serum Institute, China (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05033847
Collaborator
China National Biotec Group Company Limited (Industry), Lanzhou Institute of Biological Products Co., Ltd (Industry)
1,800
1
3
27.6
65.1

Study Details

Study Description

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 1-3 months, 3-6 months and ≥ 6 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Recombinant COVID-19 Vaccine (CHO cell)
  • Biological: COVID-19 vaccine (Vero cells)
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
Actual Study Start Date :
Sep 12, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subject last vaccination time is within 30-90 days

Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 30-90 days

Biological: Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm

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

Experimental: Subject last vaccination time is within 91-180 days

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

Biological: Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm

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

Experimental: Subject last vaccination time more than 181 days

Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 181 days

Biological: Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm

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

Outcome Measures

Primary Outcome Measures

  1. GMT of anti- SARS-CoV-2 neutralizing antibody [14th day after vaccination]

  2. GMT of anti- SARS-CoV-2 neutralizing antibody [28th day after vaccination]

  3. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody [14th day after vaccination]

  4. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody [28th day after vaccination]

Secondary Outcome Measures

  1. GMT of anti- SARS-CoV-2 neutralizing antibody [before vaccination]

  2. GMT of anti-SARS-CoV-2 IgG antibody [28th day after vaccination]

  3. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody [before vaccination]

  4. 4-fold rise of anti- SARS-CoV-2 neutralizing antibody [28th day after vaccination]

  5. GMI of anti-SARS-CoV-2 IgG antibody [before vaccination]

  6. GMI of anti-SARS-CoV-2 IgG antibody [28th day after vaccination]

  7. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 [before vaccination]

  8. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 [28th day after vaccination]

  9. The incidence and serverity of any adverse reactions [within 30 minutes after vaccination]

  10. The incidence and serverity of solicited adverse events [within 30 minutes after vaccination]

  11. The incidence and severity of adverse reactions [within 0-7 days after vaccination]

  12. The incidence and serverity of solicited adverse events [within 0-7 days after vaccination]

  13. The incidence and severity of unsolicited adverse reactions [within 8-30 days after vaccination]

  14. The incidence and serverity of solicited adverse events [within 8-30 days after vaccination]

  15. The incidence of SAE observed [after vaccination and up to 6 months after full course of immunization]

  16. The incidence of AESI observed [after vaccination and up to 6 months after full course of immunization]

Other Outcome Measures

  1. The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths [14th day after vaccination]

  2. Anti-SARS-CoV-2 neutralizing antibody [3th month, 6th month, 9th month and 12th month after full course of immunization]

  3. Anti-SARS-CoV-2 GMT of IgG antibody [3th month, 6th month, 9th month and 12th month after full course of immunization]

  4. Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 [3th month, 6th month, 9th month and 12th month after full course of immunization]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

  • 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 6 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 other vaccines within 14 days before vaccination;

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheikh Khalifa Medical City Seha Abu Dhab United Arab Emirates 519000

Sponsors and Collaborators

  • National Vaccine and Serum Institute, China
  • China National Biotec Group Company Limited
  • Lanzhou Institute of Biological Products Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Vaccine and Serum Institute, China
ClinicalTrials.gov Identifier:
NCT05033847
Other Study ID Numbers:
  • CNBG 2021001
First Posted:
Sep 5, 2021
Last Update Posted:
Jan 13, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Vaccine and Serum Institute, China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2022