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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in China

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 groups in NCT04466085
Study groupRoleWhat they receive
Population IExperimentalIn 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 IIExperimentalIn 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 ⅢPlacebo comparatorIn 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 ⅣExperimentalIn 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 ⅤExperimentalIn 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 ⅥPlacebo comparatorIn 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.

  1. 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)
  1. 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

  2. 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

  3. Neutralizing antibody GMT

    Neutralizing antibody GMT 30 days after vaccination in pre-negative people

    Measured: 30 days after inoculation

  4. Neutralizing antibody GMT

    Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination

    Measured: 6th and 12th month after inoculation

  5. 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

  6. 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

  7. Adverse events

    Adverse events 30 days after the first dose of vaccine to the entire exemption

    Measured: 30 days after inoculation

  8. 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.

  1. First posted10 Jul 2020
  2. Study start12 Jul 2020
  3. Primary completion22 Oct 2020
  4. Study completion15 Dec 2021 (estimated)

Resources

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)
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

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.

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