A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
Phase 2
- Conditions
- COVID-19
- Interventions
- Biological: high dosage inactivated SARS-CoV-2 vaccineBiological: medium dosage inactivated SARS-CoV-2 vaccineBiological: Placebo
- Registration Number
- NCT04756323
- Lead Sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
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 degrees 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 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description high dosage on day 0, 14(18~59 years) high dosage inactivated SARS-CoV-2 vaccine Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14 medium dosage on day 0, 28, 56(18~59 years) medium dosage inactivated SARS-CoV-2 vaccine Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 high dosage on day 0, 28(18~59 years) high dosage inactivated SARS-CoV-2 vaccine Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28 placebo on day 0, 28, 56(18~59 years) Placebo Three doses of placebo on the schedule of day 0,28,56 placebo on day 0, 28(18~59years) Placebo Two doses of placebo on the schedule of day 0,28 medium dosage on day 0, 14(18~59 years) medium dosage inactivated SARS-CoV-2 vaccine Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14 placebo on day 0, 14(18~59years) Placebo Two doses of placebo on the schedule of day 0,14 placebo on day 0, 28, 56(>59 years) Placebo Three doses of placebo on the schedule of day 0,28,56 high dosage on day 0, 28, 56(>59 years) high dosage inactivated SARS-CoV-2 vaccine Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 high dosage on day 0, 28, 56(18~59 years) high dosage inactivated SARS-CoV-2 vaccine Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 medium dosage on day 0, 28(18~59 years) medium dosage inactivated SARS-CoV-2 vaccine Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28 medium dosage on day 0, 28, 56(>59 years) medium dosage inactivated SARS-CoV-2 vaccine Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
- Primary Outcome Measures
Name Time Method The seropositive rates of SARS-CoV-2 neutralizing antibody Day 28 post full vaccination The seropositive level of SARS-CoV-2 neutralizing antibody Day 28 post full vaccination The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA) Day 28 post full vaccination
- Secondary Outcome Measures
Name Time Method Incidence of adverse reactions/events 0-28 days after each dose of vaccination Serious Adverse Events (SAE) within 12 months post full vaccination Level of SARS-CoV-2 IgG antibody (tested by ELISA) Day 28 post full vaccination The seropositive rates of SARS-CoV-2 neutralizing antibody Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA) Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups The seropositive level of SARS-CoV-2 neutralizing antibody Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups The seropositive level of SARS-CoV-2 IgG antibody (tested by ELISA) Day 28 after the second dose of the 3 doses group, day 14 after the full immunization of the 2 doses group, and 3, 6 and 12 months post full vaccination of all groups
Trial Locations
- Locations (1)
Jiangsu Provincial Center for Diseases Control and Prevention
🇨🇳Nanjing, Jiangsu, China