CoronavirusPhase 2NCT04466085
Clinical Study of Recombinant Novel Coronavirus Vaccine
A Phase 2 study testing Recombinant new coronavirus vaccine (CHO cell) low-dose group and Recombinant new coronavirus vaccine (CHO cells) high-dose group in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell) low-dose group and Recombinant new coronavirus vaccine (CHO cells) high-dose group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2020to 15 Dec 2021
- Phase
- Phase 2
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons with full civil capacity aged 18-59 years (both included);
- The subjects themselves voluntarily agreed to participate in the study, and signed an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol;
- Body temperature under armpit <37.3℃;
- Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.
Who cannot join
- The vital signs and physical examination results of the population specified in the plan have clinical significance as determined by the clinician;
- A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, vascular neuropathy Edema, etc.; or any previous history of serious side effects after using any vaccine or drug;
- Those with a history of SARS and SARS-CoV-2 (meet any of the following: ① previous history of SARS and SARS-CoV-2 infection or morbidity; ② during the current SARS-CoV-2 epidemic, there are patients diagnosed/suspected with the new crown Contact history);
- Have taken antipyretics or painkillers within 24 hours before the first dose of vaccination;
- Within 14 days before the first dose of vaccination, subunit vaccines, inactivated vaccines, and live attenuated vaccines within 30 days;
- People with the following diseases: Acute febrile disease; Digestive diseases (eg, diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Congenital or Acquired immunodeficiency or a history of autoimmune diseases or treatment with immunomodulators within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; however, topical medications (such as ointment, eye drops, Inhalation or nasal spray); known to be diagnosed with infectious diseases, such as: patients with tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV positive or syphilis specific antibody positive; neurological disease or Neurodevelopmental dysplasia (eg, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis); history of psychiatric illness or family History; functional spleenlessness, and spleenlessness or splenectomy for any reason; severe chronic disease or disease in progress that cannot be controlled smoothly, such as diabetes, thyroid disease; severe liver and kidney disease; respiratory tract that currently requires daily medication Diseases (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment that exacerbates respiratory diseases (eg, asthma exacerbations) within the last 5 years; has severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, Ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or a history of myocarditis or pericarditis; with thrombocytopenia, any coagulopathy, or treatment with anticoagulants; tumor patients;
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- Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the study;
- Women who are breastfeeding or pregnant (including a positive urine pregnancy test);
- Have used any research or unregistered product (medicine, vaccine, biological product or device) other than the research product within 3 months, or plan to use it during the research;
- The researchers believe that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the protocol requirements; and interfere with the assessment of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Hunan, Changsha
About this study
Official title: A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Read the detailed description
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the 3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0, 1, 2 month immunization program .
- Conditions
- Coronavirus
- Being tested
- Recombinant new coronavirus vaccine (CHO cell) low-dose group, Recombinant new coronavirus vaccine (CHO cells) high-dose group, Recombinant new coronavirus vaccine (CHO cells) placebo group
- Keywords
- NOVID-19
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant new coronavirus vaccine (CHO cell) low-dose groupBiological
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Recombinant new coronavirus vaccine (CHO cells) high-dose groupBiological
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Recombinant new coronavirus vaccine (CHO cells) placebo groupBiological
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
| Study group | Role | What they receive |
|---|---|---|
| Population I | Experimental | In population I, there were 150 subjects who injected with 2 doses of low-dose test vaccine into the deltoid muscle of the upper arm according to the 0 and 1 month immunization schedule. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group |
| Population II | Experimental | In population II, there were 150 subjects who injected with 2 doses of high-dose test vaccine in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group |
| Population Ⅲ | Placebo comparator | In population Ⅲ, there were 150 subjects who injected with 2 doses of placebo in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group |
| Population Ⅳ | Experimental | In population Ⅳ, there were 150 subjects who injected with 3 doses of low-dose test vaccine in the upper arm deltoid muscle according to the 0, 1, and 2 month immunization schedule. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group |
| Population Ⅴ | Experimental | In population Ⅴ, there were 150 subjects who injected with 3 doses of high-dose test vaccine into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group |
| Population Ⅵ | Placebo comparator | In Population Ⅵ, there were 150 subjects who injected with 3 doses of placebo into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody positive conversion rate
Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination
Measured: 30 days after inoculation
Secondary outcomes (8)
Neutralizing antibody GMT, positive rate
GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people
Measured: 14 days after inoculation
Neutralizing antibody GMT, positive conversion rate/positive rate
GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population
Measured: 14 days after inoculation
Neutralizing antibody GMT
Neutralizing antibody GMT 30 days after vaccination in pre-negative people
Measured: 30 days after inoculation
Neutralizing antibody GMT
Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination
Measured: 6th and 12th month after inoculation
Neutralizing antibody GMI, positive rate
Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination
Measured: 6th and 12th month after inoculation
IL-2, IL-4, IL-5, IL-6 and IFN-γ levels
Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination
Measured: 4th day and 12 months after inoculation
Adverse events
Adverse events 30 days after the first dose of vaccine to the entire exemption
Measured: 30 days after inoculation
Serious adverse event
Serious adverse events from day 0 after vaccination to 12 months after the entire immunization
Measured: 12 months after inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start12 Jul 2020
- Primary completion22 Oct 2020
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466085
- Sponsor's protocol ID
- NCV-Ⅱ-healthy
- Status last verified
- Dec 2020
- First submitted
- 8 Jul 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang S, Li Y, Dai L, Wang J, He P, Li C, Fang X, Wang C, Zhao X, Huang E, Wu C, Zhong Z, Wang F, Duan X, Tian S, Wu L, Liu Y, Luo Y, Chen Z, Li F, Li J, Yu X, Ren H, Liu L, Meng S, Yan J, Hu Z, Gao L, Gao GF. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infect Dis. 2021 Aug;21(8):1107-1119. doi: 10.1016/S1473-3099(21)00127-4. Epub 2021 Mar 24.
PubMed 33773111
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years
- ClinicalTrials.gov ID
- NCT04466085
- Acronym / sponsor ID
- NCV-Ⅱ-healthy
- Conditions
- Coronavirus
- Keywords
- NOVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 10 Jul 2020 (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.
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Detailed description
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.
Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the 3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0, 1, 2 month immunization program .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Population I | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose groupIn population I, there were 150 subjects who injected with 2 doses of low-dose test vaccine into the deltoid muscle of the upper arm according to the 0 and 1 month immunization schedule. |
| Population II | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose groupIn population II, there were 150 subjects who injected with 2 doses of high-dose test vaccine in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule. |
| Population Ⅲ | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupIn population Ⅲ, there were 150 subjects who injected with 2 doses of placebo in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule. |
| Population Ⅳ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose groupIn population Ⅳ, there were 150 subjects who injected with 3 doses of low-dose test vaccine in the upper arm deltoid muscle according to the 0, 1, and 2 month immunization schedule. |
| Population Ⅴ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose groupIn population Ⅴ, there were 150 subjects who injected with 3 doses of high-dose test vaccine into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months. |
| Population Ⅵ | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupIn Population Ⅵ, there were 150 subjects who injected with 3 doses of placebo into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Persons with full civil capacity aged 18-59 years (both included);
- The subjects themselves voluntarily agreed to participate in the study, and signed an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol;
- Body temperature under armpit <37.3℃;
- Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.
Key exclusion criteria (10 listed)
- The vital signs and physical examination results of the population specified in the plan have clinical significance as determined by the clinician;
- A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, vascular neuropathy Edema, etc.; or any previous history of serious side effects after using any vaccine or drug;
- Those with a history of SARS and SARS-CoV-2 (meet any of the following: ① previous history of SARS and SARS-CoV-2 infection or morbidity; ② during the current SARS-CoV-2 epidemic, there are patients diagnosed/suspected with the new crown Contact history);
- Have taken antipyretics or painkillers within 24 hours before the first dose of vaccination;
- Within 14 days before the first dose of vaccination, subunit vaccines, inactivated vaccines, and live attenuated vaccines within 30 days;
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 |
|---|---|---|
| Recombinant new coronavirus vaccine (CHO cell) low-dose groupIntramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population I, Population Ⅳ |
| Recombinant new coronavirus vaccine (CHO cells) high-dose groupIntramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population II, Population Ⅴ |
| Recombinant new coronavirus vaccine (CHO cells) placebo groupIntramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population Ⅲ, Population Ⅵ |
Primary outcome
Neutralizing antibody positive conversion rate
Time frame: 30 days after inoculation
Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination
8 secondary outcomes
Neutralizing antibody GMT, positive rate
Time frame: 14 days after inoculation
Neutralizing antibody GMT, positive conversion rate/positive rate
Time frame: 14 days after inoculation
Neutralizing antibody GMT
Time frame: 30 days after inoculation
Neutralizing antibody GMT
Time frame: 6th and 12th month after inoculation
Neutralizing antibody GMI, positive rate
Time frame: 6th and 12th month after inoculation
IL-2, IL-4, IL-5, IL-6 and IFN-γ levels
Time frame: 4th day and 12 months after inoculation
Adverse events
Time frame: 30 days after inoculation
Serious adverse event
Time frame: 12 months after inoculation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Derived from this study: PubMed 33773111Yang S, Li Y, Dai L, Wang J, He P, Li C, Fang X, Wang C, Zhao X, Huang E, Wu C, Zhong Z, Wang F, Duan X, Tian S, Wu L, Liu Y, Luo Y, Chen Z, Li F, Li J, Yu X, Ren H, Liu L, Meng S, Yan J, Hu Z, Gao L, Gao GF. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infect Dis. 2021 Aug;21(8):1107-1119. doi: 10.1016/S1473-3099(21)00127-4. Epub 2021 Mar 24.
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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 2 study testing Recombinant new coronavirus vaccine (CHO cell) low-dose group and Recombinant new coronavirus vaccine (CHO cells) high-dose group in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy 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 4 inclusion and 10 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 3 Dec 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Neutralizing antibody positive conversion rate (time frame: 30 days after inoculation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04466085, which also lists 1 linked publication.
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 3 Dec 2020.