Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Group 1:Test vaccine pGX9501 1.0 mg
Group 2:Test vaccine pGX9501 2.0 mg
Group 3:Placebo1.0 mg
Group 4:Placebo2.0 mg
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Complete 2 doses of pGX9501 (1.0 mg/2.0 mg) within 12 (+2) months prior to enrolling in this phase of the study screening. 2. Body mass index (BMI) between 18-35 kg/m^2 (inclusive). 3. Axillary temperature <37.3 ? on the day before the third booster immunization. 4. After inquiring about the medical history and examining the results of physical examination, the researchers determined that they were healthy subjects who were in line with the immunization of this product. 5. Voluntarily participate in this clinical trial and be able to correctly understand and sign the written informed consent. 6. Be able to cooperate with the researcher, comply with the requirements of the research protocol, and complete the inspection in accordance with the relevant procedures of the protocol; agree to abide by the lifestyle specified in the research protocol during the research period (restrictions on travel abroad, business trips, travel, etc.).
Exclusion criteria
Exclusion criteria: 1. Previous positive PCR test. 2. Those who were acutely infected before the third booster immunization. 3. Those with a history of fainting needles. 4. Those with metal implants within 20 cm of the planned injection site. 5. Those with tattoos, keloid formation or hypertrophic scars at the planned injection site. 6. Implanted cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD). 7. Any history of pre-excitation syndrome, such as Wolff-Parkinson-White syndrome. 8. Female subjects with positive urine pregnancy test, pregnant/lactating women, or women planning to become pregnant within 6 months (for female subjects of childbearing age =7 days) of oral or parenteral glucocorticoids (excluding topical skin and/or corticosteroids with eye drops, low-dose methotrexate, or corticosteroids at doses less than 20 mg/day); (2) Current or expected use of disease-modifying doses of antirheumatic drugs (such as azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biological disease-modifying drugs such as TNF-a inhibitors (such as infliximab, adalimumab, or etanercept); (3) Other clinically significant immunosuppression that may endanger the safety of subjects, may interfere with study evaluation or endpoint evaluation, or otherwise affect the validity of study results. 18. Those with a history of drug abuse. 19. Drinking more than 14 standard units on the day of the 3rd booster dose. 1 Standard unit contains 14g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine. 20. Blood donati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titers of binding antibodies against the S protein of SARS-CoV-2 virus (ELISA method);Geometric mean titers of neutralizing antibodies against the S protein of SARS-CoV-2 virus (serum neutralization assay);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 3 addition (day 0);Geometric Mean Fold Ratio (GMFR) in the titer of neutralizing antibodies against the S protein of SARS-CoV-2 virus (Serum Neutralization assay) relative to baseline before Dose 3 addition (day 0);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.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific T cell response (Enzyme Linked Immunospot Assay, ELISPOT), to evaluate the changes of COVID-19 spike antigen-specific T cell IFN-? levels after immunization;Positive rate of neutralizing antibody;Occurrence of Adverse Event of Special Interest (including incidence, severity, relevance, etc.);Occurrence of adverse events leading to withdrawal (including incidence, severity, correlation, etc.); | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed