COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05313646

Fengcai Zhu

Not reported

2022-04-06

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: healthy participants aged 18 years and above who have not received covid-19 vaccine. the subjects can provide with informed consent and sign informed consent form (icf). 4. the subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study. 5. axillary temperature ≤ 37.0℃. 6. negative igm and igg against sars-cov-2 7. with bmi between18.5 to 30.0 8. no history of epidemiological contact with covid-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure. 10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product.

medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination. women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study. suffering from acute febrile disease, infectious disease, or sars infection history serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmhg, diastolic blood pressure ≥110mmhg) have severe chronic diseases or unstable condition ( grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), such as diabetes, thyroid disease and so on. congenital or acquired angioedema / neuroedema. had urticaria one year before this vaccination. asplenia or functional asplenia. thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection). faintng during acupuncture treatment received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day) received blood products within 4 months before vaccination. received other investigational drugs within 1 month prior to receiving the investigational vaccines. received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines. received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine. be receiving anti-tuberculosis treatment have the history of sars-cov-2 infection or covid-19 any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent

3

Jiangsu Province Centers for Disease Control and Prevention

18

100

China

Healthy volunteers

N/A

1050

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

None

Phase 4

[{"arm_notes": "lot NCOV202101001", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "lot NCOV202101002", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "lot NCOV202101003", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]