Procedure
CRF
EVENTS, DIABETES MELLITUS, CRF
Screening of all potential subjects by medical staff was carried out. In the phase I clinical trial, eligible subjects were randomly divided into nine groups based on dose and GM-CSF addition, while in the phase II clinical trial, the subjects were divided into three groups. Then, 40 cc peripheral blood were drawn from subjects, which was processed into a DC vaccine. Seven days after the blood draw, the subject came back. If there are no signs of being infected with COVID-19, 6 cc of blood is taken again to evaluate baseline conditions before vaccination for hematology, BUN, creatinine, sodium, potassium, chloride, phosphorus, calcium, lipid profile, SGOT, SGPT, total protein, albumin, globulin, alkaline phosphatase, total bilirubin, direct bilirubin, and lipase. In patients with diabetes mellitus, fasting blood sugar and HbA1c tests are carried out, while in non-diabetic patients, only blood sugar is carried out. The vaccine was injected subcutaneously, and subjects were monitored for 30 min to assess any unintended reactions or events after vaccine administration. Then, the subjects were asked to report the local and systemic reactions they experienced within 7 days post-vaccination using a recall card. Safety evaluations were conducted again on the 7th- and 28th-day visits. The subject was then monitored again in the 3rd, 6th, 9th, and 12th months for monitoring of unwanted events. In phase II, an Enzyme-linked immunosorbent spot (ELISPOT) examination is carried out at week 2 and 4 to determine the immunogenicity of the vaccine. All data are stored in a manual and electronic Case Report Form (CRF).