COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=51154

Zhu Fengcai

iszfc@sina.com

2020-03-17

Recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

1. Aged between 18 and 60 years, 2. Able to understand the content of informed consent and willing to sign the informed consent, 3. Able and willing to complete all the secluded study process during the whole follow-up period of 6 months. 4. Negative in HIV diagnostic test, 5. Negative in serum antibodies (IgG and IgM) screening of COVID-19. 6. Normal in lung CT images (no imaging features of COVID-19), 7. Axillary temperature <=37.0 degree C, 8. The BMI index 18.5-30.0, 9. Negative in Nasopharyngeal swabs / sputum and anal swabs through RTPCR, 10. Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor, 11. General good health as established by medical history and physical examination.

1. Family history of seizure, epilepsy, brain or mental disease, 2. Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past, 3. Woman who is pregnant, breast-feeding or positive in ß-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months, 4. Any acute fever disease or infections, 5. History of SARS, 6. Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease, 7. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc., 8. Hereditary angioneurotic edema or acquired angioneurotic edema, 9. Urticaria in last one year, 10. No spleen or functional spleen, 11. Platelet disorder or other bleeding disorder may cause injection contraindication, 12. Faint at the sight of needles, 13. Prior administration of immunodepressant or corticosteroids,antianaphylaxis treatment, cytotoxic treatment in last 6 months, 14. Prior administration of blood products in last 4 months, 15. Prior administration of other research medicines in last 1 month, 16. Prior administration of attenuated vaccine in last 1 month, 17. Prior administration of inactivated vaccine in last 14 days, 18. Current anti-tuberculosis prophylaxis or therapy, 19. According to the judgement of investigator,various medical, psychological,social or other conditions, those could affect the subjects to sign informed consent.

3

Jiangsu Provincial Center for Disease Control and Prevention

18

60

China

Healthy volunteers

N/A

108

adverse reactions 7 days post injection;

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 1

[{"arm_notes": "5E10vp;1", "treatment_id": 1084, "treatment_name": "Recombinant novel coronavirus (2019-ncov) vaccine (adenovirus vector)", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1E11vp;1", "treatment_id": 1084, "treatment_name": "Recombinant novel coronavirus (2019-ncov) vaccine (adenovirus vector)", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1,5E11vp;1", "treatment_id": 1084, "treatment_name": "Recombinant novel coronavirus (2019-ncov) vaccine (adenovirus vector)", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]