Metabolic disorders
Conditions
Interventions
metabolic disorder group:covid-19 vaccine injection
control group:covid-19 vaccine injection
Sponsors
Affiliated Hospital of Hangzhou Normal University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male or non pregnant female, aged from 18 to 55 years old (including 55 years old); 2. Subjects with body mass index of 18-35kg / m2 (including 18 and 35kg / m2) at screening; 3. Subjects who can understand and agree to follow the established research procedures and participate in all research visits; 4. Subjects who agreed to collect venous blood according to the procedure; 5. Subjects who must agree to store samples for the second study; 6. Subjects willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with positive pregnancy test before screening or each vaccination; 2. Female subjects who are breastfeeding or plan to breastfeed within 60 days from the first vaccination to the last vaccination; 3. Subjects with self-reported or medical record of significant medical or mental status; 4. Acute disease (determined by PI or appropriate associate researcher) with or without fever (oral temperature 38.0 degrees C)(100.4 degrees F)) within 72 hours before each vaccination of subjects; 5. Subjects with positive results of hepatitis B surface antigen, hepatitis C virus antibody or HIV type 1 or 2 antibody in screening; 6. Subjects who participated in another investigation involving any clinical trial product within 60 days or 5 half lives (whichever is longer) before the first vaccination; 7. Subjects with a history of allergic or severe allergic reactions to any previously approved or not approved vaccines (such as allergic reactions, systemic urticaria, angioedema, other major reactions); 8. Subjects who take any drug that may be related to the impairment of immune response for a long time (continuously for more than 14 days); 9. Subjects who received immunoglobulin and / or any blood or blood products within 4 months before the first vaccination or at any time during the study period; 10. Subjects with blood cachexia or obvious coagulation disorder; 11. Subjects with any chronic liver disease, including fatty liver; 12. Subjects must agree to avoid donating blood or plasma during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2019-aCOV IgM / IgG; | — |
Countries
China
Contacts
Public ContactJunping Shi
Affiliated Hospital of Hangzhou Normal University
Outcome results
None listed