- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758273
A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
February 16, 2021 updated by: Beijing Minhai Biotechnology Co., Ltd
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
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Jiangsu Provincial Center for Diseases Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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
|
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
|
high dosage
|
PLACEBO_COMPARATOR: placebo on day 0, 14(18~59years)
Two doses of placebo on the schedule of day 0,14
|
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
|
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
|
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
|
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
|
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
|
high dosage
|
PLACEBO_COMPARATOR: placebo on day 0, 28, 56(>59 years)
Three doses of placebo on the schedule of day 0,28,56
|
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse reactions/events
Time Frame: 0-28 days after each dose of vaccination
|
0-28 days after each dose of vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serious Adverse Events (SAE)
Time Frame: within 12 months post full vaccination
|
within 12 months post full vaccination
|
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
|
Day 3 after each dose of vaccination
|
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
|
Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
|
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
|
Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
|
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
|
Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
|
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
|
Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
|
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)
|
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)
|
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)
|
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
Outcome Measure |
Time Frame |
---|---|
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)
|
Day 14 and 28 after each dose, and 3, 6, 12 months post full vaccination(18~59years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 7, 2020
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
February 28, 2022
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 16, 2021
First Posted (ACTUAL)
February 17, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 17, 2021
Last Update Submitted That Met QC Criteria
February 16, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020L001-1A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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