COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05128643

Huang Tao

ymlc01@hncdc.com

2021-11-22

Not recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

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.

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: ① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.; ② 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); ③ have been diagnosed with a known infectious disease, such as active tuberculosis, viral hepatitis, human immunodeficiency virus or treponema pallidum; ④ 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; ⑤ functional absence of spleen, and absence of spleen or splenectomy caused by any reason; ⑥ 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 ≥100mmhg); ⑦ 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; ⑧ 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.

1

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

18

100

China

Healthy volunteers

N/A

300

Immunogenicity primary endpoint

None

Phase 3

[{"arm_notes": "25\u00b5g, 3, day 0, day 30 and day 180 IM", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]