COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04313127

Zhu Fengcai

jszfc@vip.sina.com

2020-03-18

Completed

nonRCT

Non-randomized

Sequential assignment

Open label

single-center

Prevention

inclusion criteria: - aged between 18 and 60 years. - able to understand the content of informed consent and willing to sign the informed consent - able and willing to complete all the secluded study process during the whole 6 months study follow-up period. - negative in hiv diagnostic test. - negative in serum antibodies (igg and igm) screening of covid-19. - normal in lung ct images (no imaging features of covid-19 - axillary temperature ≤37.0°c. - the bmi index is 18.5-30.0. - negative in nasopharyngeal swabs / sputum and anal swabs through rt-pcr - laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor. - general good health as established by medical history and physical examination.

- family history of seizure, epilepsy, brain or mental disease - subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past. - woman who is pregnant, breast-feeding or positive in β-hcg (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months - any acute fever disease or infections. - history of sars - major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease. - serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc. - hereditary angioneurotic edema or acquired angioneurotic edema - urticaria in last one year - no spleen or functional spleen. - platelet disorder or other bleeding disorder may cause injection contraindication - faint at the sight of needles. - prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months. - prior administration of blood products in last 4 months - prior administration of other research medicines in last 1 month - prior administration of attenuated vaccine in last 1 month - prior administration of inactivated vaccine in last 14 days - current anti-tuberculosis prophylaxis or therapy - according to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

3

CanSino Biologics Inc.

18

60

China

Healthy volunteers

N/A

108

Safety indexes of adverse reactions

None

Phase 1

[{"arm_notes": "5E10 vp;1", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1E11 vp;1", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.5E11vp;1", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]