Participants, randomization, and blinding
obesity, autoimmune laboratory abnormalities, immunodeficiency diseases, thromboembolic, physical/mental disabilities, Hepatitis C
OBESITY, UNCONTROLLED HYPERTENSION, HIV INFECTION, INVASIVE CANCER, COVID-19 INFECTION, IMMUNODEFICIENCY DISEASE, HEPATITIS B, HEPATITIS C
In phase I, as many as 106 prospective subjects were screened, and 33 subjects met the criteria and received the vaccine. Meanwhile, in phase II, as many as 227 prospective subjects were screened, and 145 subjects met the criteria and received the vaccine. The subjects included in this study were over 18 years old, generally healthy, not pregnant or planning to get pregnant for productive women, willing to comply with research protocols, and provided informed consent in writing. While the exclusion criteria consist of subjects with symptoms of active COVID-19 infection, positive PCR test results infected with SARS-CoV-2 less than 3 months, rapid examination of reactive SARS-CoV-2 IgG antibodies, having received other COVID-19 vaccines, positive pregnant, subjects with immunodeficiency diseases (HIV infection, Hepatitis C, and Hepatitis B), taking immunosuppressive drugs and corticosteroids for a long time, conditions that require oxygen supplementation, diagnosed with invasive cancer and receiving anticancer therapy, a history of thromboembolism/genetic predisposition of thromboembolic events/in antithromboembolic treatment other than low-dose aspirin, physical/mental disabilities that make a person unable to carry out daily activities, obesity (BMI > 40), uncontrolled hypertension (cystole > 180, diastole > 100), and unwilling to sign written consent. In phase I, in addition to the above conditions, subjects with uncontrolled, autoimmune laboratory abnormalities based on the Food and Drug Administration was excluded, as well as a history of obtaining blood products within 3 months.All subjects that met the criteria were then randomized. In phase I, the subjects were divided into nine groups based on three antigen dose groups (0.1, 0.33, and 1.0 mcg) and three GM-CSF groups administered (0, 250, and 500 mcg). In phase II, subjects were divided into three different dose groups (0.1, 0.33, and 1.0 mcg). Neither the researchers nor the subjects knew the doses of antigens and GM-CSF.