Status unknownNCT04758273Updated Feb 17, 2021

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

A Phase 1 interventional study of medium dosage inactivated SARS-CoV-2 vaccine and high dosage inactivated SARS-CoV-2 vaccine in COVID-19, sponsored by Beijing Minhai Biotechnology Co., Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 180
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

COVID-19

Browse trials for

COVID-19 7,633

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 180 participants (actual)

Study arms

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
Biological: medium dosage inactivated SARS-CoV-2 vaccine
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
Biological: high dosage inactivated SARS-CoV-2 vaccine
Placebo comparator
placebo on day 0, 14(18~59years)
Two doses of placebo on the schedule of day 0,14
Biological: 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
Biological: medium dosage inactivated SARS-CoV-2 vaccine
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
Biological: high dosage inactivated SARS-CoV-2 vaccine
Placebo comparator
placebo on day 0, 28, 56(18~59 years)
Three doses of placebo on the schedule of day 0,28,56
Biological: 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
Biological: medium dosage inactivated SARS-CoV-2 vaccine
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
Biological: high dosage inactivated SARS-CoV-2 vaccine
Placebo comparator
placebo on day 0, 28, 56(>59 years)
Three doses of placebo on the schedule of day 0,28,56
Biological: Placebo

Interventions

Biologicalmedium dosage inactivated SARS-CoV-2 vaccine
medium dosage
Biologicalhigh dosage inactivated SARS-CoV-2 vaccine
high dosage
BiologicalPlacebo
placebo

What researchers measure

Primary outcomes

Incidence of adverse reactions/events
Time frame: 0-28 days after each dose of vaccination

Secondary outcomes

Serious Adverse Events (SAE)
Time frame: 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
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
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
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
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
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）
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 outcomes

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)

Study locations

1 site

Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu 210000, China

Registry details

Key details

Study ID: NCT04758273
Lead sponsor: Beijing Minhai Biotechnology Co., Ltd
Collaborators: Shenzhen Kangtai Biological Products Co., LTD, Jiangsu Province Centers for Disease Control and Prevention
Responsible party: Sponsor
First posted: Feb 17, 2021
Start date: Oct 7, 2020
Primary completion: Jun 30, 2021 (estimated)
Completion: Feb 28, 2022 (estimated)
Last update: Feb 17, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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