COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=140883

Lei Liu

zyyhlb@yeah.net

2021-11-22

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

1. Subjects aged 18 ~ 59 who can provide legal identity certificates, both male and female, 2. The subjects understand the contents of the informed consent form and the vaccination, voluntarily sign the informed consent form, and have the ability to use the thermometer, scale and fill in the diary card and contact card as required, 3. Be able to communicate well with researchers, understand and abide by the requirements of this study, 4. For female subjects: no possibility of fertility (including amenorrhea for at least 1 year or surgical sterilization with medical records) or negative pregnancy test before inclusion in this study, The subjects voluntarily agreed to continue to use effective contraceptives with their partners within 3 months after completing the vaccination. Effective contraceptive measures include abstinence or adequate contraceptive measures [such as intrauterine or implantable contraceptive devices, oral contraceptives, injection or embedded contraception, slow-release local contraceptives, condoms (male), diaphragm, cervical cap, etc.), 5. Healthy subjects or subjects with mild basic diseases [at least 3 months before being selected for this study, they were in a stable state without aggravation (no hospitalization or major adjustment of treatment plan, etc.), 6. The second or third dose of the new coronavirus inactivated vaccine has been vaccinated for more than 6 months before enrollment. The interval between the first and second doses of novel coronavirus inactivated vaccine is 21 to 56 days, and the interval between the second and third doses of novel coronavirus inactivated vaccine is not less than 6 months.

1. A history of COVID-19 or the use of any COVID-19 preventive medicine other than the new coronavirus inactivated vaccine, 2. Abnormal blood pressure and pulse test results during the screening period (awake state pulse <50 beats/min or >100 beats/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) and clinical significance judged by the investigator, 3. Positive for SARS-CoV-2 etiological test (RT-PCR test), 4. There is a history of SARS, MERS and other coronavirus infection or disease history, 5. Fever (axillary temperature >=37.3 degree) on the day of vaccination and within the last 72 hours, 6. Women are breastfeeding, 7. Plan to become pregnant or plan to discontinue effective contraceptive measures within 6 months after vaccination with the experimental vaccine, 8. The clinical investigators and sponsor staff are specifically involved in this trial, 9. History of severe allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc., 10. Any vaccine within 28 days before the experimental vaccine, 11. Those who have participated in the clinical trials of other drugs within 28 days before vaccination or plan to participate in other drug clinical trials within 12 months after the vaccination, 12. Has hereditary bleeding tendency or abnormal coagulation function (such as: coagulation factor deficiency, coagulation disorder or thrombocytopenia), or has a history of severe bleeding, 13. Based on known medical history or diagnosis confirmed to have diseases that affect the function of the immune system, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immunodeficiency (eg: HIV infection), uncontrolled autoimmune diseases, After organ transplantation, etc., 14. Asplenia or functional asplenia, 15. Long-term use (continuous use >= 14 days) of immunosuppressive drugs or other immunomodulatory drugs (such as cortisol hormones: prednisone or similar drugs, interferon, etc.) within 6 months before the experimental vaccine, but topical use is allowed Medication (such as ointment, eye drops, inhaler, or nasal spray), and topical use should not exceed the dose recommended in the instructions, 16. Received immunoglobulin and/or blood products within 3 months before the experimental vaccine, 17. Suspected or known alcohol dependence or drug abuse, which may affect safety evaluation or affect subject compliance, 18. Plan to permanently relocate from the region before the end of the study or to leave the region for a long time during the study visit, 19. Other factors deemed inappropriate by the investigator to participate in this trial.

1

The Third People's Hospital of Shenzhen

18

59

China

Healthy volunteers

N/A

200

Neutralizing antibody titer of sars-cov-2;

Phase 0

[{"arm_notes": "", "treatment_id": 2516, "treatment_name": "Chimpanzee adenovirus vector", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]