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

NCT04758273 | Unknown Phase 1

• 1 other identifier: 2020L001-1A
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions/events

  0-28 days after each dose of vaccination

Secondary Outcomes (8)

• Serious Adverse Events (SAE)

  within 12 months post full vaccination

• Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)

  Day 3 after each dose of vaccination

• The seropositive rates of SARS-CoV-2 neutralizing antibody

  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

  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)

  Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination

Other Outcomes (1)

• The SARS-CoV-2 antibody level of IgG1, IgG2, IgG3, IgG4 and Nucleoprotein

  Day 14 and 28 after each dose, and 3, 6, 12 months post full vaccination(18~59years)

Study Arms (9)

medium dosage on day 0, 14(18~59 years)

EXPERIMENTAL

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

high dosage on day 0, 14(18~59 years)

EXPERIMENTAL

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

placebo on day 0, 14(18~59years)

PLACEBO COMPARATOR

Two doses of placebo on the schedule of day 0,14

Biological: Placebo

medium dosage on day 0, 28, 56(18~59 years)

EXPERIMENTAL

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

high dosage on day 0, 28, 56(18~59 years)

EXPERIMENTAL

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

placebo on day 0, 28, 56(18~59 years)

PLACEBO COMPARATOR

Three doses of placebo on the schedule of day 0,28,56

Biological: Placebo

medium dosage on day 0, 28, 56(>59 years)

EXPERIMENTAL

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

high dosage on day 0, 28, 56(>59 years)

EXPERIMENTAL

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

placebo on day 0, 28, 56(>59 years)

PLACEBO COMPARATOR

Three doses of placebo on the schedule of day 0,28,56

Biological: Placebo

Interventions

medium dosage inactivated SARS-CoV-2 vaccine BIOLOGICAL

medium dosage

medium dosage on day 0, 14(18~59 years); medium dosage on day 0, 28, 56(18~59 years); medium dosage on day 0, 28, 56(>59 years)

high dosage inactivated SARS-CoV-2 vaccine BIOLOGICAL

high dosage

high dosage on day 0, 14(18~59 years); high dosage on day 0, 28, 56(18~59 years); high dosage on day 0, 28, 56(>59 years)

Placebo BIOLOGICAL

placebo

placebo on day 0, 14(18~59years); placebo on day 0, 28, 56(18~59 years); placebo on day 0, 28, 56(>59 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Beijing Minhai Biotechnology Co., Ltd: lead
• Shenzhen Kangtai Biological Products Co., LTD: collaborator
• Jiangsu Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 17, 2021
• Study Start: October 7, 2020
• Primary Completion: June 30, 2021
• Study Completion: February 28, 2022
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

CN (1)