COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=55455

Fengcai Zhu

jszfc@vip.sina.com

2021-07-05

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Prevention

1) Be at least 18 years old at the time of entry, 2) Able to comply with the requirements of the clinical research plan to complete all trial procedures and sign the informed consent form, 3) For female subjects: infertility (surgical sterilization or at least one year after menopause) or willing to use appropriate contraceptive measures from 30 days before vaccination to 3 months after vaccination, including abstinence or effective contraception measures (such as intrauterine or implantable contraceptive devices, oral contraceptives, uterine diaphragm or condoms combined with contraceptive gel), 4) For subjects in the sequential subgroup: complete two doses of inactivated COVID-19 vaccine 28 to 60 days before enrollment, 5) Healthy subjects with past illnesses: within 3 months before enrollment, the condition was stable without deterioration, hospitalization or major changes in treatment, such as hypertension (controlled at systolic blood pressure <140mmHg, diastolic blood pressure <90mmHg, diabetes, asthma, thyroid disease, etc.

1) Axillary temperature > 37.0 degree C, 2) Patients with Corona Virus Disease 2019 (COVID-19), severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS). 3) Patients with history of COVID-19 vaccines or other candidate vaccines (except sequential subgroup), 4) Pregnant (i.e. positive urine pregnancy test) or breastfeeding during the vaccination period. If pregnant after all vaccination, the follow-up study will not be excluded and will be followed up to the end of delivery, 5) Those who had fever (axillary temperature >=38.0 degree C) within 3 days before vaccination or 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 anti influenza virus drugs such as Tamiflu, Relenza, Symmetrel or flumadine), 6) Patients with immune deficiency diseases, important organs include 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 believe may have adverse effects on immune response), etc, 7) Long-term(lasting more than 14 days) use of immunosuppressants and other immunoregulatory drugs or systemic use of corticosteroids (Topical ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included ) within 6 months before vaccination 8) History of hemorrhagic disease (such as factor deficiency, coagulation disorder or platelet disorder), obvious bleeding or bruise after venipuncture, 9) Received immunoglobulin and/or blood preparations within 3 months before vaccination, or plan to use them during the study period, 10) Had received subunit or inactivated vaccine within 14 days before vaccination, or had received live attenuated vaccine within 28 days before vaccination, 11) Those who have received other research drugs or vaccines within one month before vaccination, or plan to use other research drugs or vaccines during the research period, 12) Received any intranasal medication or nasal surgery within 7 days before vaccination, 13) Those with a history of severe allergy, including severe adverse reactions such as allergy, urticaria, dyspnea, angioneurotic edema, etc., or allergic to any component of the vaccine used in this trial, 14) 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.

2

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

18

100

China

Healthy volunteers

N/A

400

The positive conversion rate and antibody level of COVID-19 serum IgG after second doses of 28d vaccination;The positive conversion rate and antibody level of 28d IgA antibody in nasopharyngeal swabs after second doses of vaccination;Levels of novel coronavirus spiking protein specific cellular immune response in whole blood at 28 days after inoculation of the second dose of vaccine (positive rate and relative level of IFN-? secreted after PBMC-stimulated culture);

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

Not reported

[{"arm_notes": "2;Days0-28", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "2;Days0-28", "treatment_id": 394, "treatment_name": "Delns1-2019-ncov-rbd-opt1", "treatment_type": "Replicating viral vector", "pharmacological_treatment": "Vaccine"}]