COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=59326

Jing Zhang

zhanggj61@fudan.edu.cn

2020-09-11

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Male or female volunteers, age: 18-59 years old (including threshold). 2. Body weight: male >= 50 kg, female >= 45 kg, body mass index (BMI) in the range of 18-30 kg / m2 (including critical value). 3. From signing the informed consent form to 12 months after the last vaccine injection, the fertile female subjects or partners with fertile male subjects agreed and could take effective contraceptive measures, such as avoiding sexual life or using oral contraceptives, condoms, intrauterine devices and other reliable contraceptive measures. 4. Subjects with normal or abnormal physical examination without clinical significance. 5. Subjects with normal vital signs (body temperature, blood pressure, pulse, respiratory rate) or abnormal, but the researchers think it has no clinical significance. The results of ECG were consistent with any of the following 12 leads (1) The 12 lead ECG and clinical laboratory results were within the normal reference range, (2) The 12 lead ECG and clinical laboratory results were beyond the normal reference range, but they were < 1 level defined in the guidelines for classification of adverse events in clinical trials of preventive vaccines, (3) Other 12 lead ECG and clinical laboratory results were within or beyond the normal reference value range, but the researchers did not consider them to be clinically significant (indicators not covered in the guidelines for the classification of adverse events in clinical trials of preventive vaccines). 7. The subjects who voluntarily participate in the clinical trial can correctly understand and sign the written informed consent. 8. Be able to cooperate with the research objects, comply with the requirements of the research protocol, and complete the inspection according to the relevant procedures of the program, agree to abide by the lifestyle specified in the research program (restrictions on going abroad, business trip, travel, etc.) during the study period.

1. Patients with any following positive 2019-nCoV screening results should be excluded: (1) Serum antibodies (IgG and IgM) of the new crown were positive, (2) Lung CT showed new coronal imaging features, (3) The results of RT-PCR were positive. 2. HCV antibody, HBsAg, TP antibody, HIV antibody or tuberculosis positive (lung CT or tuberculosis infection T cell test [QuantiFERON TB]). 3. Patients who have been diagnosed with SARS and mers virus in the past. 4. Patients with acute infection within 2 weeks before vaccination. 5. Objects with a history of needle syncope. 6. Objects with metal implants within 20 cm of the planned injection site. 7. Objects with tattoo, scar formation or hypertrophic scar at the planned injection site. 8. Subjects with pacemaker or automatic implantable cardioverter defibrillator (AICD). 9. Patients with any preexcitation syndrome and history, such as Wolff Parkinson white syndrome. 10. Female subjects with positive blood pregnancy test, pregnant / lactating women, or women with pregnancy plan within 12 months. 11. Patients with diseases leading to immune deficiency or immunosuppression, such as congenital immunodeficiency, hematological malignancies (leukemia, lymphoma), etc., who undergo organ transplantation and bone marrow transplantation. 12. Patients with allergic diseases or objects with allergic constitution (such as history of vascular edema / neuroedema or urticaria) or alcohol allergy. 13. Patients who have experienced severe allergic reactions or known allergies to this product or its preparation ingredients (DNA plasmid, sodium citrate, etc.) before vaccination. 14. Patients who have or are suffering from cardiovascular diseases of clinical significance (except that drugs can control hypertension), respiratory, liver (except mild fatty liver), kidney, gastrointestinal (except chronic gastritis), endocrine, hematological or nervous system diseases, and can significantly change the absorption, metabolism or clearance of drugs, or cause risks during the use of IP, or interfere with the interpretation of data. Examples of excluded diseases include but are not limited to: angina pectoris, heart failure, asthma, hepatitis, liver cirrhosis, kidney damage, diabetes, anemia, epilepsy, schizophrenia, etc. 15. Patients with previous psychiatric history. 16. Patients who had received surgery or chemotherapy within 4 weeks before vaccination of the study vaccine, or who planned to have surgery during the study period. 17. Subjects who have received blood products (e.g., immunoglobulin), research drugs / devices, or planned users during the study period within 12 weeks before vaccination. 18. Subjects who have been vaccinated with other vaccines within 4 weeks before the vaccination of the research vaccine or who have been vaccinated with other vaccines within 2 months after inoculation of the research vaccine (except for emergency vaccination of unplanned vaccines). 19. The subjects who received immunosuppressive therapy within 6 months before signing the informed consent form included: (1) Long term use (>= 7 days) of oral or parenteral glucocorticoids (excluding inhaled, topical skin and / or eye drops containing corticosteroids, low-dose methotrexate or corticosteroids with doses less than 20 mg / day). (2) Current or prospective targets of anti rheumatic drugs with remission doses (such as azathioprine, cyclophosphamide, cyclosporin, methotrexate) and biological disease remission dru

4

Huashan Hospital Affiliated to Fudan University

18

59

China

Healthy volunteers

N/A

45

Incidence of all adverse events related to vaccine (including incidence; severity; etc.);

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 1

[{"arm_notes": "0.5mg;1 EP using the CELLECTRA\u00ae 2000", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0mg;1 EP using the CELLECTRA\u00ae 2000", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2.0mg;1 EP using the CELLECTRA\u00ae 2000", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "EP using the CELLECTRA\u00ae 2000", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]