Clinical Study on the Immune Program of Recombinant Novel Coronavirus COVID-19) Vaccine (CHO Cell)

  • STATUS
    Recruiting
  • End date
    Oct 12, 2022
  • participants needed
    300
  • sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Updated on 30 November 2021
Accepts healthy volunteers

Summary

Popular topicClinical study on the immune program of recombinant Novel Coronavirus (COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate the immunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months in persons aged 18 years and over. Secondary purpose: To evaluate the safety of trial vaccine in people 18 years of age and older.

Overall design: In this study, a single-arm design was used to evaluate the immunogenicity and safety of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months in persons aged 18 years and older.

Study population:The study involved people 18 years of age and older. Test groupsA total of 300 subjects were enrolled, including 200 in the 18-59 age group and 100 in the 60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule.

Description

Overall design:In this study, a single-arm design was used to evaluate the immunogenicity and safety of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months in persons aged 18 years and older.

Intervention: A total of 300 subjects were enrolled, including 200 in the 18-59 age group and 100 in the 60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule.

Immunogenicity observation:

About 5.0mL of venous blood was collected from all subjects for immunogenicity test before the first dose, before the third dose, on day 14 and 180 after full immunization.

Safety observation:

All adverse events (AE) were collected 30 minutes after each dose, all AE (both solicitor and non-solicitor) were collected 0-7 days after each dose, and all AE (non-solicitor) were collected 8-30 days after each dose. All SAE from the first dose up to 6 months after full immunization.

Solicitation AE (the following events occurring within 7 days of vaccination) :

Adverse events at the inoculation site (local) : pain, swelling, induration, redness, rash, pruritus; Vital signs: fever; Non-inoculated site (systemic) adverse events: headache, fatigue/fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough.

Vital signs and physical examination:

  1. All subjects underwent a daily armpit temperature examination during the screening period, before subsequent doses, and within 7 days after each dose.
  2. All subjects underwent physical examination (skin and cardiopulmonary auscultation) and blood pressure measurement during the screening period.

ADE/VED (Antibody Enhancement/vaccine Enhancement disease) Risk Monitoring:

After vaccination (at least one dose of experimental vaccine), if the subject is diagnosed with COVID-19, he/she should go to the hospital for hospitalization or be isolated in accordance with the epidemic prevention and control requirements of the area in which he/she is located. A special investigation should be conducted for the existence of ADE/VED in severe/critical cases/deaths.

Details
Condition Coronavirus Disease 2019
Treatment Recombinant new coronavirus vaccine (CHO cell)
Clinical Study IdentifierNCT05128643
SponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Last Modified on30 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Persons over the age of 18 with full capacity for civil conduct
The subject voluntarily agrees to participate in the study and signs the informed consent, and can provide valid identification, understand and comply with the requirements of the study protocol
Fertile male and female subjects of reproductive age agreed to use effective contraceptive measures from the beginning of the study to 2 months after full vaccination

Exclusion Criteria

Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature 37.3 on the day of enrollment
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, angiopantic edema, etc.; Or have a history of severe adverse reactions to any of the above mentioned vaccines or medications
people who currently have or have a history of COVID-19
Persons suffering from the following diseases
have thrombocytopenia, any coagulation dysfunction or receive anticoagulant
treatment, etc
Congenital or acquired immune deficiency or autoimmune disease history or
received immunomodulatory treatment within 6 months Treatment, such as
immunosuppressive doses of glucocorticoid (dose reference: equivalent to
prednisone 20mg/ day, more than one weeks); Or monoclonal antibodies; Or
thymosin; Or interferon; However, topical application (e.g. ointments, eye
drops) is allowed Liquid, inhalant or nasal spray)
Have been diagnosed with a known infectious disease, such as active
tuberculosis, viral hepatitis, human immunodeficiency virus or treponema
pallidum
Neurological disorders (e.g., convulsions, migraines, epilepsy, stroke
epileptic seizures in the last three years, encephalopathy, focal neurological
deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis)
History of mental illness or family history
functional absence of spleen, and absence of spleen or splenectomy caused by
any reason
There are serious chronic diseases or diseases in the progressive stage can
not be controlled smoothly, such as diabetes, drugs can not control
Hypertension (systolic blood pressure 160mmHg and/or diastolic blood pressure
mmHg)
Severe liver and kidney diseases; Any current respiratory illness requiring
routine medication (e.g., chronic obstructive pulmonary disease [COPD]
asthma) or any exacerbation of respiratory illness (e.g., exacerbation of
asthma) within the last 5 years; A history of serious cardiovascular disease
(e.g., congestive heart failure, cardiomyopathy, ischemic heart disease
arrhythmia, conduction block, myocardial infarction, pulmonary heart disease)
or myocarditis or pericarditis
Cancer patients (except basal cell carcinoma)
\. had taken an antipyretic or painkiller within 24 hours before the first
dose of vaccine
\. Those who have received novel coronavirus vaccine, or subunit vaccine
and/or inactivated vaccine within 7 days before the first dose, or live
attenuated vaccine within 14 days
\. Have received blood or blood-related products, including immunoglobulin
within 3 months; Or planned for use during the study period
\. Lactating or pregnant women (including women of childbearing age who have
positive urine pregnancy test), or women who plan to have a pregnancy within 2
months after full vaccination of the test vaccine or their partners
\. Have participated in or are currently participating in other COVID-19
related clinical trials
\. 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
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