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A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04758273
Recruitment Status : Unknown
Verified February 2021 by Beijing Minhai Biotechnology Co., Ltd.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
Shenzhen Kangtai Biological Products Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Beijing Minhai Biotechnology Co., Ltd

Study Description
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Brief Summary:
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: medium dosage inactivated SARS-CoV-2 vaccine Biological: high dosage inactivated SARS-CoV-2 vaccine Biological: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above: a Randomized, Double-blind, Placebo Parallel-controlled Phase I Clinical Trial
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: medium dosage on day 0, 14(18~59 years)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
 Biological: medium dosage inactivated SARS-CoV-2 vaccine
medium dosage
Experimental: high dosage on day 0, 14(18~59 years)
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
 Biological: high dosage inactivated SARS-CoV-2 vaccine
high dosage
Placebo Comparator: placebo on day 0, 14(18~59years)
Two doses of placebo on the schedule of day 0,14
 Biological: Placebo
placebo
Experimental: medium dosage on day 0, 28, 56(18~59 years)
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
 Biological: medium dosage inactivated SARS-CoV-2 vaccine
medium dosage
Experimental: high dosage on day 0, 28, 56(18~59 years)
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
 Biological: high dosage inactivated SARS-CoV-2 vaccine
high dosage
Placebo Comparator: placebo on day 0, 28, 56(18~59 years)
Three doses of placebo on the schedule of day 0,28,56
 Biological: Placebo
placebo
Experimental: medium dosage on day 0, 28, 56(>59 years)
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
 Biological: medium dosage inactivated SARS-CoV-2 vaccine
medium dosage
Experimental: high dosage on day 0, 28, 56(>59 years)
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
 Biological: high dosage inactivated SARS-CoV-2 vaccine
high dosage
Placebo Comparator: placebo on day 0, 28, 56(>59 years)
Three doses of placebo on the schedule of day 0,28,56
 Biological: Placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse reactions/events [ Time Frame: 0-28 days after each dose of vaccination ]

Secondary Outcome Measures :
  1. Serious Adverse Events (SAE) [ Time Frame: within 12 months post full vaccination ]
  2. Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function) [ Time Frame: Day 3 after each dose of vaccination ]
  3. The seropositive rates of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination ]
  4. The seropositive level of SARS-CoV-2 neutralizing antibody [ Time Frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination ]
  5. The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA) [ Time Frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination ]
  6. The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA) [ Time Frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination ]
  7. The proportion of IFN-γ positive cells (by ELISpot) [ Time Frame: Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group） ]
  8. Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA) [ Time Frame: Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group） ]

Other Outcome Measures:
  1. The SARS-CoV-2 antibody level of IgG1, IgG2, IgG3, IgG4 and Nucleoprotein [ Time Frame: Day 14 and 28 after each dose, and 3, 6, 12 months post full vaccination(18~59years) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy permanent residents aged 18 years and above;
  2. Subjects agree to sign the informed consent forms voluntarily;
  3. Subjects are able to comply with the requirements of the clinical trial protocol;
  4. Armpit temperature <=37.0 degree C;
  5. Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.

Exclusion Criteria:

  1. Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
  2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
  3. Subjects with history of SARS virus infection by self-reported;
  4. Positive in throat swab through RT-PCR;
  5. Positive in SARS-CoV-2 antibody test;
  6. Subjects with abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration;
  7. Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
  8. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history;
  9. Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  10. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >=90 mmHg; subjects aged >=60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
  11. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
  12. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
  13. Subjects receiving anti-TB treatment;
  14. Subjects receiving other research drugs within 6 months before vaccination;
  15. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
  16. Subjects receiving blood products within 3 months before administration;
  17. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
  18. Subjects vaccinated with other vaccine within 7 days before vaccination;
  19. The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758273


Locations
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China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Beijing Minhai Biotechnology Co., Ltd
Shenzhen Kangtai Biological Products Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Beijing Minhai Biotechnology Co., Ltd
ClinicalTrials.gov Identifier: NCT04758273    
Other Study ID Numbers: 2020L001-1A
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs