NCT05069129

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,848

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 14, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

October 3, 2021

Last Update Submit

January 30, 2023

Conditions

COVID-19 PneumoniaCoronavirus Infections

Keywords

COVID-19

Outcome Measures

Primary Outcomes (12)

  • The incidence and serverity of any adverse reactions

    within 30 minutes after vaccination

  • The incidence and serverity of solicited adverse events

    within 30 minutes after vaccination

  • The incidence and serverity of solicited adverse reactions

    within 0-7 days after vaccination

  • The incidence and severity of unsolicited adverse reactions

    within 0-7 days after vaccination

  • The incidence and serverity of solicited adverse reactions

    within 8-30 days after vaccination

  • The incidence and serverity of solicited adverse events

    within 8-30 days after vaccination

  • The incidence of SAE observed

    after vaccination and up to 6 months after full course of immunization.

  • The incidence of AESI observed

    after vaccination and up to 6 months after full course of immunization

  • GMT of subject's anti- SARS-CoV-2 neutralizing antibody

    15th day after vaccination

  • GMT of subject's anti- SARS-CoV-2 neutralizing antibody

    30th day after vaccination

  • Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    15th day after vaccination

  • Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    30th day after vaccination

Secondary Outcomes (14)

  • Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody

    before vaccination

  • Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody

    30th day after the full course of vaccination

  • Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    before vaccination

  • Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody

    30th day after the full course of vaccination

  • GMI of subject's anti-SARS-CoV-2 IgG antibody

    before vaccination

  • +9 more secondary outcomes

Other Outcomes (6)

  • The vaccine efficay of recombinant COVID-19 vaccine (CHO cells) against COVID-19, severe cases and deaths

    14th day after vaccination

  • Anti-SARS-CoV-2 neutralizing antibody

    3th month, 6th month, 9th month and 12th month after full course of immunization

  • Anti-SARS-CoV-2 GMT of IgG antibody

    3th month, 6th month, 9th month and 12th month after full course of immunization

  • +3 more other outcomes

Study Arms (4)

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

EXPERIMENTAL

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

Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)Biological: Inactivated COVID-19 vaccine (Vero cells)

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

EXPERIMENTAL

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

Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)Biological: Inactivated COVID-19 vaccine (Vero cells)

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

EXPERIMENTAL

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

Biological: Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)Biological: Inactivated COVID-19 vaccine (Vero cells)

Safety Observation Group

EXPERIMENTAL

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

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

Interventions

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

Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08) in the deltoid muscle of the upper arm

Subject last vaccination time is within 4-6 months（sequential clinical trial group）Subject last vaccination time is within 7-9 months（sequential clinical trial group）Subject last vaccination time more than 9 months（sequential clinical trial group）
Inactivated COVID-19 vaccine (Vero cells)BIOLOGICAL

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

Subject last vaccination time is within 4-6 months（sequential clinical trial group）Subject last vaccination time is within 7-9 months（sequential clinical trial group）Subject last vaccination time more than 9 months（sequential clinical trial group）
3 doses Recombinant COVID-19 Vaccine (CHO cell，NVSI-06-08)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

Safety Observation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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）;
  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Khalifa Medical City

SEHA, Abu Dhab, 519000, United Arab Emirates

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35760812DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

October 6, 2021

Study Start

October 14, 2021

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations

AE(1)