Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine

NCT04445194 | Unknown Phase 1

• 1 other identifier: NCV-Ⅰ-healthy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronavirus

Keywords

Recombinant Novel Coronavirus Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to one year after the last vaccination

Secondary Outcomes (1)

• Immunogenic end point

  Within 6 months after the last dose of vaccination

Study Arms (3)

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.

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.

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.

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

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, 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 Officials

• Hong Ren, master

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 24, 2020
• Study Start: June 22, 2020
• Primary Completion: October 22, 2020
• Study Completion: September 20, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

CN (1)