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)
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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Beijing Minhai Biotechnology Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen Kangtai Biological Products Co., LTD
name: Jiangsu Province Centers for Disease Control and Prevention
First posted: 2021-02-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of adverse reactions/events
timeFrame: 0-28 days after each dose of vaccination
Secondary outcomes:
measure: Serious Adverse Events (SAE)
timeFrame: within 12 months post full vaccination
measure: Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)
timeFrame: Day 3 after each dose of vaccination
measure: The seropositive rates of SARS-CoV-2 neutralizing antibody
timeFrame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
measure: The seropositive level of SARS-CoV-2 neutralizing antibody
timeFrame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
measure: The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)
timeFrame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
measure: The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA)
timeFrame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
measure: The proportion of IFN-γ positive cells (by ELISpot)
timeFrame: 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）
measure: Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA)
timeFrame: 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 outcomes:
measure: The SARS-CoV-2 antibody level of IgG1, IgG2, IgG3, IgG4 and Nucleoprotein
timeFrame: Day 14 and 28 after each dose, and 3, 6, 12 months post full vaccination(18~59years)
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Diseases Control and Prevention
state: Jiangsu
Study officials:
References: