Clinical Study of Recombinant Novel Coronavirus Vaccine

NCT04466085 | Unknown Phase 2

• 1 other identifier: NCV-Ⅱ-healthy
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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 sample size of each group was 150 cases.

Conditions

Coronavirus

Keywords

NOVID-19

Outcome Measures

Primary Outcomes (1)

• Neutralizing antibody positive conversion rate

  Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination

  30 days after inoculation

Secondary Outcomes (8)

• Neutralizing antibody GMT, positive rate

  14 days after inoculation

• Neutralizing antibody GMT, positive conversion rate/positive rate

  14 days after inoculation

• Neutralizing antibody GMT

  30 days after inoculation

• Neutralizing antibody GMT

  6th and 12th month after inoculation

• Neutralizing antibody GMI, positive rate

  6th and 12th month after inoculation

Study Arms (6)

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.

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.

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.

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.

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.

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.

Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group

Interventions

Recombinant new coronavirus vaccine (CHO cell) low-dose group BIOLOGICAL

Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Population I; Population Ⅳ

Recombinant new coronavirus vaccine (CHO cells) high-dose group BIOLOGICAL

Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Population II; Population Ⅴ

Recombinant new coronavirus vaccine (CHO cells) placebo group BIOLOGICAL

Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Population Ⅲ; Population Ⅵ

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Hunan, Changsha, China

Location

Related Publications (1)

• 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.

  PMID: 33773111 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 10, 2020
• Study Start: July 12, 2020
• Primary Completion: October 22, 2020
• Study Completion: December 15, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

CN (1)