Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus（COVID-19） Vaccine (CHO Cell)

NCT05109598 | Completed Phase 2

• 1 other identifier: LKM-2021-NCV03
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age. Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3\~17 and the age of 18\~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell). Study population:400 healthy people aged 3 to 17 years old, both male and female.

Conditions

COVID-19

Keywords

Recombinant Novel Coronavirus Vaccine

Outcome Measures

Primary Outcomes (3)

• Immunogenic end point

  The positive rate of sars-cov-2 neutralizing antibody, RBD protein binding antibody (IgG) GMT and 14 days after the whole course immunization of the test vaccine in the target population.

  14 days after full vaccination

• The number of adverse events after intramuscular injection

  All adverse events (AE) from the first dose to 1 month after the whole course of immunization

  from the first dose to 1 month after the whole course of immunization

• The number of serious adverse events after intramuscular injection

  Incidence of all serious adverse events (SAE) and vaccine related SAE from the first dose to 12 months after the whole course of vaccination.

  from the first dose to 12 months after the whole course of vaccination.

Secondary Outcomes (1)

• Immunopersistence results

  6 months after the last dose of vaccination

Study Arms (2)

Population I

EXPERIMENTAL

Population I has 400 subjects aged 3 to 17 who were recruited by this trial.

Biological: Recombinant new coronavirus vaccine (CHO cell)

Population II

EXPERIMENTAL

Population II will use 400 subjects aged of 18-59 in the phase III clinical trial in China whose blood has been collected.

Biological: Recombinant new coronavirus vaccine (CHO cell)

Interventions

Recombinant new coronavirus vaccine (CHO cell) BIOLOGICAL

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

Population I; Population II

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At least 3 \~ 17 years old (both included);
• The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol;
• The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements;
• There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period;
• Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination.

You may not qualify if:

• The results of physical examination during screening period are abnormal and clinically significant (not suitable for vaccination) as determined by clinicians;
• Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (\> 14 years old, axillary temperature ≥ 37.3 ℃; ≤ 14 years old, axillary temperature ≥ 37.5 ℃);
• Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, etc; Or have a history of the above serious side effects after the use of any vaccine or drug in the past;
• had previous history of SARS and SARS-CoV-2.
• Taking antipyretics or painkillers within 24 hours before the first dose of vaccine;
• persons who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 7 days or within 7 days before the first dose of vaccine are inoculated with inward subunit vaccine and / or inactivated vaccine.
• Have received blood or blood related products, including immunoglobulin, within 3 months before the vaccination of the test vaccine; Or planned use during the study;
• Persons suffering from the following diseases:
• ① Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
• ② Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
• ③ History of congenital or acquired immune deficiency or autoimmune diseases or receiving immunomodulator treatment within 6 months, such as immunosuppressive dose of Glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one week); Or monoclonal antibody; Or thymosin; Or interferon, etc; However, topical medication (such as ointment, eye drops, inhalants or nasal sprays) is allowed;
• ④ It is known that it is diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis present, human immunodeficiency virus infection or Treponema pallidum infection.
• ⑤ Neurological diseases or neurodysplasia (e.g., convulsions, migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse myelitis); History of psychosis or family history;
• ⑥ Functional absence of spleen, and absence of spleen or splenectomy for any reason;
• ⑦ There are serious chronic diseases or disease in progress can not be controlled smoothly, such as diabetes, drugs can not control hypertension.

Sponsors & Collaborators

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

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 411228, China

Location

Related Publications (1)

• Gao L, Li Y, He P, Chen Z, Yang H, Li F, Zhang S, Wang D, Wang G, Yang S, Gong L, Ding F, Ling M, Wang X, Ci L, Dai L, Gao GF, Huang T, Hu Z, Ying Z, Sun J, Zuo X. Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial. Lancet Child Adolesc Health. 2023 Apr;7(4):269-279. doi: 10.1016/S2352-4642(22)00376-5. Epub 2023 Feb 17.

  PMID: 36803632 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tao Huang

  Hunan Provincial Center for Disease Control and Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 5, 2021
• Study Start: November 4, 2021
• Primary Completion: February 14, 2022
• Study Completion: April 6, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)