Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
A1 Adult group:pGX9501 1.0 mg / placebo
A2 Elderly group:pGX9501 1.0 mg / placebo
B1 Adult group:pGX9501 2.0 mg/ placebo
B2 Elderly group:pGX9501 2.0 mg/ placebo
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old and = 60 years old and <= 85 years old, regardless of gender (for elderly subjects); 3.Body mass index (BMI) is between 18-35 kg/m2 (including upper and lower limits); 4.Axillary temperature < 37.3 degrees C on the day of vaccination. 5.Subjects are considered by the investigator as healthy subjects eligible for immunization with this product based on inquiry of medical history and inspection of the physical examination results. 6.Subjects volunteer to participate in this clinical trial, and are able to correctly understand and sign the Informed Consent Form (ICF); 7.Subjects can cooperate with the investigator, observe the requirements of the protocol, and complete the examinations according to relevant procedures in the protocol; agree to abide by the modes of life stipulated in the protocol (restrictions on going abroad, business trips or travel) during the study period.
Exclusion criteria
Exclusion criteria: Subject can be excluded by any of the following: 1.COVID-19 antibody test is positive; 2.Those with confirmed infection of SARS or MERS virus previously. 3.Those with an acute infection within 2 weeks before vaccination. 4.Those with a history of needle sickness. 5.Those with a metal implant within 20 cm from the planned injection site. 6.Those with a tattoo, keloid formation or hypertrophic scar at the planned injection site. 7.Those implanted with cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD). 8.Those with any pre-excitation syndrome or relevant history, e.g. Wolff-Parkinson-White syndrome. 9.Female subjects with a positive result of urine pregnancy test, pregnant/lactating women, or women planning to be pregnant within 12 months (for women of childbearing potential aged = 7 days) of oral or parenteral glucocorticoids (excluding topical corticosteroids, and/or corticosteroids containing eye drops, low-dose methotrexate, or corticosteroids with a dose less than 20 mg/day); Those who are using or are expected to use antirheumatic drugs (e.g. azathioprine, cyclophosphamide, cyclosporin, and methotrexate) and biological drugs for disease alleviation, e.g. TNF-a inhibitors (e.g., infliximab, adalimumab, or etanercept); Those with other immunosuppression effects of clinical significance that may affect the safety of subjects, interfere with the study assessment or endpoint evaluation, or otherwise affect the validity of the stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of all adverse events related to vaccine (including incidence, severity, etc.);GMT of specific antibody against S protein of SARS-CoV-2;GMT of neutralizing antibody against S protein of SARS-CoV-2; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.);Occurrence of Adverse Event of Special Interest (including incidence, severity, relevance, etc.);Occurrence of adverse events leading to withdrawal (including incidence, severity, correlation, etc.);Specific antibody response (ELISA method) against S protein of SARS CoV-2 virus;Neutralizing antibody reaction (pseudovirus neutralization method) against S protein of SARS CoV-2 virus;Geometric Mean Fold Ratio (GMFR) in the titer of binding antibodies against the S protein of SARS-CoV-2 virus (ELISA method) relative to baseline before Dose 2 addition (day 0);Geometric Mean Fold Ratio (GMFR) of neutralizing antibody titer (pseudovirus neutralization method) of anti SARS CoV-2 virus S protein relative to the baseline before the first dose of vaccine (Day 0);Seroconversion rate (ELISA method);Seroconversion rate (pseudovirus neutralization method); | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed