Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
A1 group:pGx9501 (0.5 mg)/placebo
A2 group:pGx9501 (1.0 mg)/placebo
A3 group:pGx9501 (2.0 mg)/placebo
B1 group:pGx9501 (0.5 mg)/placebo
B2 group:pGx9501 (1.0 mg)/placebo
B3 group:pGx9501 (2.0 mg)/placebo
Sponsors
Sichuan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Body mass index (BMI) between 18~35 kg/m2 (including the upper and lower limits); 3. For subjects in group A, complete two doses of the approved inactivated new crown vaccine within 3 months (± 15 days) before participating in the screening of this study, and the interval between the second dose and the first dose The time is 21 days (+10 days); 4. For subjects in group B, two doses of the approved inactivated COVID-19 vaccine should be completed within 6 months (± 15 days) before participating in the screening of this study, and the interval between the second dose and the first dose should be The time is 21 days (+10 days); 5. After inquiring about the medical history and examining the results of physical examination, the researchers determined that they are healthy subjects who are in line with the immunization of this product; 6. Voluntarily participate in this clinical trial, and be able to correctly understand and sign the written informed consent; 7. Be able to cooperate with the researcher, comply with the requirements of the research program, and complete the inspection in accordance with the relevant procedures of the program; agree to abide by the lifestyle stipulated in the research program during the research period (restrictions on going abroad, business trips, tourism, etc.).
Exclusion criteria
Exclusion criteria: 1. Those with a positive PCR test for the new coronavirus or a positive PCR test on site; 2. Those with a history of fainting needles; 3. Untreated/uncontrolled hypertension (systolic blood pressure >=140mmHg and/or diastolic blood pressure >=90mmHg) on ??the day of vaccination; 4. Axillary temperature >=37.3 ? on the day of vaccination; 5. There is no site for intradermal injection inoculation and electrical pulse operation on the skin outside the deltoid muscle, or there are other situations that are not suitable for electrical pulse operation. The following are considered unacceptable: those with tattoos, keloids, or hypertrophic scars at the planned injection site; those with an implanted pacemaker or automatic implantable cardioverter-defibrillator (AICD); Those with metal implants within 20 cm of the site; those with disabilities in both upper extremities and unable to perform intradermal injection into the lateral deltoid muscle of the upper arm; other circumstances that affect the evaluation of adverse events at the injection site; 6. Anyone with pre-excitation syndrome and medical history, such as Wolff-Parkinson-White syndrome; 7. Female subjects with positive urine pregnancy test, pregnant/lactating women, or women planning to become pregnant within 6 months after participating in the study (applicable to female subjects of childbearing age); 8. Suffering from immunodeficiency or immunosuppression diseases, such as congenital immunodeficiency, malignant hematological tumors (leukemia, lymphoma), etc.; or a history of organ transplantation and bone marrow transplantation; 9. Patients with allergic diseases or allergic constitution (such as history of angioedema/neurotic edema or urticaria); or a history of severe allergies (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia) purpura, dyspnea, etc.); or those who are known to be allergic to DNA vaccines and their components; 10. Previous or current clinically significant cardiovascular (except drug-controlled hypertension), respiratory, liver (except mild fatty liver), kidney, gastrointestinal tract (except chronic gastritis), endocrinology, hematology or neurological disease, which, in the judgment of the investigator, may affect the evaluation of the study; or pose a risk during administration of the study vaccine; or interfere with the interpretation of the data. Excluded conditions include, but are not limited to: coronary heart disease, angina pectoris, heart failure, cardiomyopathy, chronic obstructive pulmonary edema, pulmonary fibrosis, asthma, hepatitis, cirrhosis, renal impairment, diabetes, anemia, cerebrovascular disease, epilepsy , mental illness or schizophrenia, family history of mental illness, etc.; 11. Those who have received surgery or chemotherapy within 4 weeks before the third dose booster immunization, or plan to undergo surgery within 4 weeks after the booster immunization; 12. Received blood products (such as immune globulin), investigational drugs/devices within 12 weeks before the third dose booster immunization, or planned to use them during the study; 13. Received other vaccines within 4 weeks before the third dose of booster immunization or received other new crown vaccines after the completion of 2 doses of inactivated vaccine and before the third dose of booster immunization; 14. Immunosuppression caused by taking drugs, including: long-term use (continuous use >=7 days) of oral or parenteral glu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT of binding antibody against S protein of SARS-CoV-2;GMT of neutralizing antibody against S protein of SARS-CoV-2;Geometric mean increase in the titer (ELISA*) of binding antibody against SARS-CoV-2 virus S protein relative to baseline before Dose 3 addition (day 0) * (GMFR);Geometric mean increase in the titer of neutralizing antibodies against SARS-CoV-2 virus S protein (Serum Neutralization assay) relative to baseline before Dose 3 addition (day 0) * (GMFR);The occurrence of solicited adverse events (including incidence, severity, correlation, etc.);Occurrence of non-solicited adverse events (including incidence, severity, correlation, etc.);Occurrence of serious adverse events (including incidence, severity, correlation, etc.);The occurrence of Adverse Event of Special Interest (including incidence, severity, relevance, etc.);The occurrence of adverse events leading to withdrawal (including incidence, severity, correlation, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific T cell response (ELISA, ELISPOT, to evaluate the changes of COVID-19 spike antigen-specific T cell IFN-? levels after immunization;Positive rate of neutralizing antibody; | — |
Countries
China
Contacts
Public ContactHuang Ting
Sichuan Provincial Center for Disease Control and Prevention
Outcome results
None listed