Back to resultsA Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
medium dosage inactivated SARS-CoV-2 vaccine
high dosage inactivated SARS-CoV-2 vaccine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Healthy permanent residents aged 18 years and above;
- Subjects agree to sign the informed consent forms voluntarily;
- Subjects are able to comply with the requirements of the clinical trial protocol;
- Armpit temperature <=37.0 degree C;
- 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:
- 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;
- Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- Subjects with history of SARS virus infection by self-reported;
- Positive in throat swab through RT-PCR;
- Positive in SARS-CoV-2 antibody test;
- Subjects with abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration;
- 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;
- Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history;
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- 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;
- Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- Subjects receiving anti-TB treatment;
- Subjects receiving other research drugs within 6 months before vaccination;
- Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
- Subjects receiving blood products within 3 months before administration;
- Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
- Subjects vaccinated with other vaccine within 7 days before vaccination;
- The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Sites / Locations
- Jiangsu Provincial Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
medium dosage on day 0, 14(18~59 years)
high dosage on day 0, 14(18~59 years)
placebo on day 0, 14(18~59years)
medium dosage on day 0, 28, 56(18~59 years)
high dosage on day 0, 28, 56(18~59 years)
placebo on day 0, 28, 56(18~59 years)
medium dosage on day 0, 28, 56(>59 years)
high dosage on day 0, 28, 56(>59 years)
placebo on day 0, 28, 56(>59 years)
Arm Description
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Two doses of placebo on the schedule of day 0,14
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of placebo on the schedule of day 0,28,56
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of placebo on the schedule of day 0,28,56
Outcomes
Primary Outcome Measures
Incidence of adverse reactions/events
Secondary Outcome Measures
Serious Adverse Events (SAE)
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)
The seropositive rates of SARS-CoV-2 neutralizing antibody
The seropositive level of SARS-CoV-2 neutralizing antibody
The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)
The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA)
The proportion of IFN-γ positive cells (by ELISpot)
Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA)
Full Information
NCT ID
NCT04758273
First Posted
February 9, 2021
Last Updated
February 16, 2021
Sponsor
Beijing Minhai Biotechnology Co., Ltd
Collaborators
Shenzhen Kangtai Biological Products Co., LTD, Jiangsu Province Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04758273
Brief Title
A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Minhai Biotechnology Co., Ltd
Collaborators
Shenzhen Kangtai Biological Products Co., LTD, Jiangsu Province Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medium dosage on day 0, 14(18~59 years)
Arm Type
Experimental
Arm Description
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Arm Title
high dosage on day 0, 14(18~59 years)
Arm Type
Experimental
Arm Description
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Arm Title
placebo on day 0, 14(18~59years)
Arm Type
Placebo Comparator
Arm Description
Two doses of placebo on the schedule of day 0,14
Arm Title
medium dosage on day 0, 28, 56(18~59 years)
Arm Type
Experimental
Arm Description
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Arm Title
high dosage on day 0, 28, 56(18~59 years)
Arm Type
Experimental
Arm Description
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Arm Title
placebo on day 0, 28, 56(18~59 years)
Arm Type
Placebo Comparator
Arm Description
Three doses of placebo on the schedule of day 0,28,56
Arm Title
medium dosage on day 0, 28, 56(>59 years)
Arm Type
Experimental
Arm Description
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Arm Title
high dosage on day 0, 28, 56(>59 years)
Arm Type
Experimental
Arm Description
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Arm Title
placebo on day 0, 28, 56(>59 years)
Arm Type
Placebo Comparator
Arm Description
Three doses of placebo on the schedule of day 0,28,56
Intervention Type
Biological
Intervention Name(s)
medium dosage inactivated SARS-CoV-2 vaccine
Intervention Description
medium dosage
Intervention Type
Biological
Intervention Name(s)
high dosage inactivated SARS-CoV-2 vaccine
Intervention Description
high dosage
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Incidence of adverse reactions/events
Time Frame
0-28 days after each dose of vaccination
Secondary Outcome Measure Information:
Title
Serious Adverse Events (SAE)
Time Frame
within 12 months post full vaccination
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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）
Title
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 Pre-specified Outcome Measures:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy permanent residents aged 18 years and above;
Subjects agree to sign the informed consent forms voluntarily;
Subjects are able to comply with the requirements of the clinical trial protocol;
Armpit temperature <=37.0 degree C;
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:
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;
Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
Subjects with history of SARS virus infection by self-reported;
Positive in throat swab through RT-PCR;
Positive in SARS-CoV-2 antibody test;
Subjects with abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration;
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;
Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history;
Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
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;
Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
Subjects receiving anti-TB treatment;
Subjects receiving other research drugs within 6 months before vaccination;
Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
Subjects receiving blood products within 3 months before administration;
Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
Subjects vaccinated with other vaccine within 7 days before vaccination;
The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Facility Information:
Facility Name
Jiangsu Provincial Center for Diseases Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
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