COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=63754

Fengcai Zhu

jszfc@vip.sina.com

2020-11-06

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Subjects over 18 years old at the time of enrollment, 2. The subjects who can comply with the requirements of the clinical study protocol, complete all the trial procedures, and sign the informed consent form, 3. Since December 2019, the subjects who have not been to the epidemic area, have not contacted the new coronal infection or suspected cases, and are in the non isolation period, and there are no new coronal infection or suspected cases in the same village / community, 4. New Coronavirus total antibody test (colloidal gold method) negative subjects, 5. For female subjects, they should have no pregnancy plan within 12 months after the first dose of vaccine and agree to use effective contraceptive measures.

1. Subjects with axillary body temperature above 37.0 degrees C, 2. Patients with history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (mers), 3. Female subjects with positive urine pregnancy test, or pregnant or lactating women, 4. Subjects with acute sinusitis or acute rhinitis within 3 days before vaccination, or subjects with chronic sinusitis or chronic rhinitis accompanied with acute attack symptoms, 5. Patients with intranasal granuloma, nasal septum deviation, nasal polyps and other abnormal conditions that may affect specimen collection or vaccination judged by clinicians, 6. Subjects who had fever within 3 days before vaccination (axillary temperature >= 38.0 degrees C) or who had any acute disease in the past 5 days and needed systemic application of antibiotics or antiviral drugs (including but not limited to the use of antiviral drugs such as Tamiflu, Relenza, symmetry or flumadine), 7. Subjects with severe chronic medical diseases or whose condition can not be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg), diabetes, asthma, thyroid diseases, etc, 8. Patients with immune deficiency diseases, including primary diseases, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, splenectomy or splenectomy caused by any condition, and other immune diseases that researchers think may affect immune response), etc, 9. Subjects who received immunoglobulin and / or blood preparations within 3 months before vaccination, or planned to use them during the study period, 10. Subjects who received subunit or inactivated vaccine within 14 days before vaccination, or who received live attenuated vaccine within 28 days before vaccination, 11. Subjects who have received other research drugs or vaccines within one month before vaccination, or who plan to use other research drugs or vaccines during the research period, 12. Subjects who received any intranasal medication or nasal surgery within 7 days before vaccination, 13. Subjects who used immunosuppressants and other immunomodulatory drugs for a long time (lasting for more than 14 days) within 6 months before vaccination, or systemic use of corticosteroids (local ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included), 14. Subjects with a history of severe allergy, including those who have had severe adverse reactions such as allergy, urticaria, dyspnea, angioneurotic edema, etc., or who are allergic to any component of the vaccine used in this trial, 15. Subjects who had taken or planned to use aspirin, drugs containing aspirin or salicylate within 14 days before vaccination, 16. Subjects who reported coagulation disorders or coagulation dysfunction in the past, 17. After inquiring about the subjects' medical history and related physical examination, the researcher judged that various medical, psychological, social, occupational or other conditions may affect the progress of clinical research.

3

Jiangsu Provincial Center For Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)

18

60

China

Healthy volunteers

N/A

720

Serum total antibodies; IgG antibodies; and neutralizing antibodies of SARS-CoV-2 one month after the last dose of vaccination (if the total antibodies against SARS-CoV-2 are positive; the positive conversion rate and antibody levels of IgG and neutralizing antibodies will be further tested);The positive conversion rate and antibody level of SARS-CoV-2 total antibody; IgA antibody; and neutralizing antibody in nasopharyngeal swabs (if the total anti- SARS-CoV-2 antibody is positive; the IgA antibody and neutralizing antibody will be further tested) one month after the last dose of vaccination;The specific cellular immune response level of SARS-CoV-2 spike protein in whole blood 14 days after the last dose of vaccination ;

| Declared number of arm (3.0) differs from found arms (5.0)

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "2 (day0-14)", "treatment_id": 394, "treatment_name": "Delns1-2019-ncov-rbd-opt1", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2 (day0-21)", "treatment_id": 394, "treatment_name": "Delns1-2019-ncov-rbd-opt1", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}]