COVID-19Phase 1NCT04758273
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 study testing medium dosage inactivated SARS-CoV-2 vaccine and high dosage inactivated SARS-CoV-2 vaccine in people with COVID-19, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- medium dosage inactivated SARS-CoV-2 vaccine and high dosage inactivated SARS-CoV-2 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2020to 28 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210000
About this study
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
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
- Being tested
- medium dosage inactivated SARS-CoV-2 vaccine, high dosage inactivated SARS-CoV-2 vaccine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medium dosage inactivated SARS-CoV-2 vaccineBiological
medium dosage
high dosage inactivated SARS-CoV-2 vaccineBiological
high dosage
PlaceboBiological
placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions/events
Measured: 0-28 days after each dose of vaccination
Secondary outcomes (8)
Serious Adverse Events (SAE)
Measured: within 12 months post full vaccination
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)
Measured: Day 3 after each dose of vaccination
The seropositive rates of SARS-CoV-2 neutralizing antibody
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start7 Oct 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Minhai Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Kangtai Biological Products Co., LTD, Jiangsu Province Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758273
- Sponsor's protocol ID
- 2020L001-1A
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04758273
- Acronym / sponsor ID
- 2020L001-1A
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Beijing Minhai Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen Kangtai Biological Products Co., LTD, Jiangsu Province Centers for Disease Control and Prevention
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| medium dosage on day 0, 14(18~59 years) | Experimental | Biological: medium dosage inactivated SARS-CoV-2 vaccineTwo doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14 |
| high dosage on day 0, 14(18~59 years) | Experimental | Biological: high dosage inactivated SARS-CoV-2 vaccineTwo doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14 |
| placebo on day 0, 14(18~59years) | Placebo comparator | Biological: PlaceboTwo doses of placebo on the schedule of day 0,14 |
| medium dosage on day 0, 28, 56(18~59 years) | Experimental | Biological: medium dosage inactivated SARS-CoV-2 vaccineThree doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
| high dosage on day 0, 28, 56(18~59 years) | Experimental | Biological: high dosage inactivated SARS-CoV-2 vaccineThree doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
| placebo on day 0, 28, 56(18~59 years) | Placebo comparator | Biological: PlaceboThree doses of placebo on the schedule of day 0,28,56 |
| medium dosage on day 0, 28, 56(>59 years) | Experimental | Biological: medium dosage inactivated SARS-CoV-2 vaccineThree doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
| high dosage on day 0, 28, 56(>59 years) | Experimental | Biological: high dosage inactivated SARS-CoV-2 vaccineThree doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56 |
| placebo on day 0, 28, 56(>59 years) | Placebo comparator | Biological: PlaceboThree doses of placebo on the schedule of day 0,28,56 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medium dosage inactivated SARS-CoV-2 vaccinemedium dosage | Biological | 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 vaccinehigh dosage | Biological | 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) |
| Placeboplacebo | Biological | placebo on day 0, 14(18~59years), placebo on day 0, 28, 56(18~59 years), placebo on day 0, 28, 56(>59 years) |
Primary outcome
Incidence of adverse reactions/events
Time frame: 0-28 days after each dose of vaccination
8 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）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing medium dosage inactivated SARS-CoV-2 vaccine and high dosage inactivated SARS-CoV-2 vaccine in people with COVID-19, run by Beijing Minhai Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions/events (time frame: 0-28 days after each dose of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.