CoronavirusPhase 1NCT04445194
Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine
A Phase 1 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
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2020to 20 Sep 2021
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Comply with the observation age of this clinical trial: 18-59 years old (both included) adults.
- The subjects themselves voluntarily agreed to participate in the study, and signed an informed consent form, and can provide legal identification; understand and abide by the requirements of the trial protocol; can participate in a half-year follow-up.
- Body temperature under armpit <37.3 ℃.
- Body mass index (BMI) at 18-28kg / m² (inclusive).
- Female and male subjects of childbearing age took effective contraception during the study.
Who cannot join
- The vital signs, physical examination and laboratory test indicators of the population specified in the plan are abnormal and have clinical significance as determined by the clinician;
- Have a history of severe allergies to any component of the research vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any previous History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin eczema, dyspnea, angioedema, etc .
- Those with a history of SARS and COVID-19, meet any of the following:
- previous history of SARS-CoV and SARS-CoV-2 infection or morbidity;
- during the current SARS-CoV-2 epidemic, there is a diagnosis with the new crown Patient / suspected patient contact history;
- positive for SARS-CoV-2 IgM and / or IgG antibodies;
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- positive for real-time fluorescent RT-PCR nucleic acid.
- Have taken antipyretics or painkillers within 24 hours before the first dose of vaccine.
- Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose of vaccination, and inoculate live attenuated vaccine within 30 days.
- People with the following diseases:
- Acute febrile illness;
- Digestive system 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 autoimmune disease history or within 6 months of receiving immunomodulator treatment, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc .; but local medications (such as ointment are allowed , Eye drops, inhalation or nasal spray), local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure;
- The chest imaging examination is clinically significant if the investigator judges that the abnormality is clinically positive, or any positive of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus HIV antibody or syphilis specific antibody;
- Neurological diseases or neurodevelopmental disorders (eg, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis ); History of mental illness or family history;
- Functional spleenlessness, and spleenlessness or splenectomy for any reason;
- There are serious chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes and thyroid disease;
- Severe liver and kidney diseases; respiratory diseases that currently require daily medication (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment that exacerbates respiratory diseases (eg, exacerbated asthma) within the last 5 years; suffers History of severe cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;
- have thrombocytopenia, any coagulopathy, or receive anticoagulant treatment, etc .;
- Cancer patients;
- Have received blood or blood-related products, including immunoglobulin within 3 months; or plan to use it during the study.
- Lactating women or pregnant women (including blood or urine pregnancy test positive).
- Any research or unregistered product (medicine, vaccine, biological product or device) other than the research product was used within 3 months before the application of the test drug / vaccine, or planned to be used during the study.
- People with halo and halo needles.
- The investigator believes that the presence of 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
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo Parallel Controlled, Safety and Tolerability Phase I Clinical Trial of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Healthy People Between 18 and 59 Years of Age
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.
Read the detailed description
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose . The researchers conducted a safety evaluation and agreed to follow-up after discharge.
In this trial, all adverse events (AE), all AEs from 0-7 days, and all AEs from 8-30 days will be collected 30 minutes after each dose, and all AEs will be collected from the first dose to 30 days after the entire vaccination, and the first dose will be inoculated to the full course All serious adverse events (SAE) 6 months after vaccination.
- 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
- Recombinant Novel Coronavirus Vaccine
- 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 | Population I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group |
| Population II | Experimental | Population II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group |
| Population Ⅲ | Placebo comparator | Population Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm. 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.
The number of adverse events after intramuscular injection
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site, vital signs, blood routine, blood biochemistry, and urine routine.
Measured: Up to one year after the last vaccination
Secondary outcomes (1)
Immunogenic end point
All subjects The levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ levels before each vaccination, day 14 after the first vaccination, day 7 after the second vaccination, and 1 and 6 months after the entire vaccination.
All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Positive rate of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG).
All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Titer level and its multiplier than before exemption of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG).
Measured: Within 6 months after the last dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start22 Jun 2020
- Primary completion22 Oct 2020
- Study completion20 Sep 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Beijing Chao Yang Hospital
- Responsible party
- Sponsor
- Investigators
- Hong Ren, master, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445194
- Sponsor's protocol ID
- NCV-Ⅰ-healthy
- Status last verified
- Dec 2020
- First submitted
- 16 Jun 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 Multi-center, Double-blind, Randomized, Placebo Parallel Controlled, Safety and Tolerability Phase I Clinical Trial of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Healthy People Between 18 and 59 Years of Age
- ClinicalTrials.gov ID
- NCT04445194
- Acronym / sponsor ID
- NCV-Ⅰ-healthy
- Conditions
- Coronavirus
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Beijing Chao Yang Hospital
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 24 Jun 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.
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.
Detailed description
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose . The researchers conducted a safety evaluation and agreed to follow-up after discharge.
In this trial, all adverse events (AE), all AEs from 0-7 days, and all AEs from 8-30 days will be collected 30 minutes after each dose, and all AEs will be collected from the first dose to 30 days after the entire vaccination, and the first dose will be inoculated to the full course All serious adverse events (SAE) 6 months after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Population I | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose groupPopulation I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine. |
| Population II | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose groupPopulation II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm. |
| Population Ⅲ | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupPopulation Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Comply with the observation age of this clinical trial: 18-59 years old (both included) adults.
- The subjects themselves voluntarily agreed to participate in the study, and signed an informed consent form, and can provide legal identification; understand and abide by the requirements of the trial protocol; can participate in a half-year follow-up.
- Body temperature under armpit <37.3 ℃.
- Body mass index (BMI) at 18-28kg / m² (inclusive).
- Female and male subjects of childbearing age took effective contraception during the study.
Key exclusion criteria (26 listed)
- The vital signs, physical examination and laboratory test indicators of the population specified in the plan are abnormal and have clinical significance as determined by the clinician;
- Have a history of severe allergies to any component of the research vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any previous History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin eczema, dyspnea, angioedema, etc .
- Those with a history of SARS and COVID-19, meet any of the following:
- Have taken antipyretics or painkillers within 24 hours before the first dose of vaccine.
- Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose of vaccination, and inoculate live attenuated vaccine 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 |
| 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 |
| 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 |
Primary outcome
The number of adverse events after intramuscular injection
Time frame: Up to one year after the last vaccination
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site, vital signs, blood routine, blood biochemistry, and urine routine.
1 secondary outcome
Immunogenic end point
Time frame: Within 6 months after the last dose of vaccination
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.
Hong Ren, master principal investigator
The Second Affiliated Hospital of Chongqing Medical University
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 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 5 inclusion and 26 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 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?
The number of adverse events after intramuscular injection (time frame: Up to one year after the last vaccination). 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 NCT04445194, 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.