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

  • STATUS
    Recruiting
  • End date
    Feb 2, 2024
  • participants needed
    1848
  • sponsor
    National Vaccine and Serum Institute, China
Updated on 2 November 2021
Accepts healthy volunteers

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.

Details
Condition Coronavirus, severe acute respiratory syndrome (sars), sars, Coronavirus Infection, COVID 19 Pneumonia
Treatment Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08), Inactivated COVID-19 vaccine (Vero cells), 3 doses Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08)
Clinical Study IdentifierNCT05069129
SponsorNational Vaccine and Serum Institute, China
Last Modified on2 November 2021

Eligibility

Yes No Not Sure

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 insertsequential clinical trial group
Never vaccinated COVID-19 vaccinesafety 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 includeSevere 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, encephalopathylong term history of alcohol and drug abuse, history of thyroidectomy, infectious diseasesor mental illness or family historylineal
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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