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Clinical Study of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Combined With Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT05107375
Recruitment Status : Recruiting
First Posted : November 4, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Brief Summary:

Popular topic:Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older.

Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.


Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Biological: Tetravalent influenza virus lysis vaccine Biological: Recombinant new coronavirus vaccine (CHO cell) group Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Study on Immunogenicity and Safety of Recombinant Novel Coronavirus(COVID-19)Vaccine (CHO Cell) Combined With Tetravalent Influenza Virus Lysis Vaccine in People Aged 18 Years and Over
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : November 19, 2021
Estimated Study Completion Date : March 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Population Ⅰ
One dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) were given in the contralateral arm on day 0, the second dose of recombinant Novel coronavirus vaccine (CHO cells) on day 30 and the third dose of recombinant Novel coronavirus vaccine (CHO cells) on day 60, all in the upper arm deltoid muscle.
Biological: Tetravalent influenza virus lysis vaccine
Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.

Biological: Recombinant new coronavirus vaccine (CHO cell) group
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein.

Experimental: Population Ⅱ
The first dose of recombinant Novel Coronavirus vaccine (CHO cells) was given on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant Coronavirus vaccine (CHO cells) on day 60, all in the upper arm deltoid muscle.
Biological: Tetravalent influenza virus lysis vaccine
Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.

Biological: Recombinant new coronavirus vaccine (CHO cell) group
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein.




Primary Outcome Measures :
  1. Primary endpoint: [ Time Frame: 14 days after vaccination ]
    Positive conversion rate of SARS-COV-2 neutralizing antibody at day 14 after full inoculation of recombinant Novel Coronavirus vaccine (CHO cells).


Secondary Outcome Measures :
  1. Secondary endpoint: [ Time Frame: 14 days after vaccination ]
    SARS-cov-2 neutralizing antibody GMT on day 14 after full immunization with recombinant Novel Coronavirus vaccine (CHO cells);

  2. Secondary endpoint: [ Time Frame: 1 months after full vaccination ]
    HI antibody GMT, positive conversion rate and serum protection rate of influenza virus typing 30 days after influenza vaccination;

  3. Secondary endpoint: [ Time Frame: 1 months after full vaccination ]
    Incidence of adverse reactions/events at each time point after each dose of recombinant Novel Coronavirus vaccine (CHO cells) (at least 30 min, 0-7 days and 8-30 days after inoculation);

  4. Secondary endpoint: [ Time Frame: within 30 minutes of influenza vaccination ]
    Incidence of adverse reactions/events within 30 minutes of influenza vaccination;

  5. Secondary endpoint: [ Time Frame: 1 months after full vaccination ]
    Incidence of all serious adverse events (SAE) and incidence of vaccine-related SAE from the first dose of recombinant Novel Coronavirus vaccine (CHO cells) to 1 month after full vaccination.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subjects aged 18 and above with full capacity for civil conduct, who can provide valid identification;
  2. The subjects voluntarily agree to participate in the study and sign the informed consent to understand and comply with the requirements of the study protocol;
  3. Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex using effective contraceptive methods and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex). At the same time, subjects agreed to take effective contraceptive measures for 1 month from the signing of informed consent to the full immunization and no pregnancy plans during this period.

Exclusion Criteria:

  1. History of novel coronavirus infection confirmed or asymptomatic infected persons or positive nucleic acid test of novel Coronavirus;
  2. SARS virus history;
  3. For those with fever, axillary temperature ≥37.3℃ on the day of inclusion;
  4. A past history of severe allergy to any vaccine, or to the active ingredient of the test vaccine, any inactive ingredient, or substance used in the manufacturing process, including aluminum preparations, egg protein, neomycin, formaldehyde, tritonX-100, such as: Acute anaphylaxis, dyspnea, angioneurotic edema, etc., or allergies during previous vaccinations of the same kind;
  5. Patients with uncontrolled epilepsy and other serious neurological diseases (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.);
  6. Patients with acute diseases, or acute episodes of chronic diseases, or uncontrolled severe chronic diseases (such as hypertension that cannot be controlled by drugs, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
  7. Patients at the active stage of autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.), patients with congenital or acquired immune deficiency, HIV infection with opportunistic infection or uncontrolled malignant tumor, lymphoma and leukemia;
  8. No spleen, or splenic operation history;
  9. Received immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
  10. Has received blood or blood-related products, including immunoglobulin (including rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to experimental vaccine vaccination; Or planned use of the experimental vaccine within 1 month of vaccination;
  11. If subunit vaccine and inactivated vaccine are administered within 7 days prior to experimental vaccine inoculation, live attenuated vaccine shall be administered within 14 days prior to experimental vaccine inoculation;
  12. Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test);
  13. Those who have participated in or are participating in clinical trials related to COVID-19, or are participating in clinical trials of other drugs, or have received COVID-19 vaccines; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05107375


Contacts
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Contact: Tao Huang 15084736658 ymlc01@hncdc.com

Locations
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China, Hunan
Hunan Provincial Center for Disease Control and Prevention Recruiting
Changsha, Hunan, China, 411228
Contact: Tao Huang    15084736658    ymlc01@hncdc.com   
Sponsors and Collaborators
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Investigators
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Principal Investigator: Tao Huang Hunan Center for Disease Control and Prevention
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Responsible Party: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
ClinicalTrials.gov Identifier: NCT05107375    
Other Study ID Numbers: IIT-LKM-2021-NCV01
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.:
Recombinant Novel Coronavirus Vaccine
Tetravalent influenza virus lysis vaccine
Additional relevant MeSH terms:
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Influenza, Human
Coronavirus Infections
COVID-19
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs