Created at Source Raw Value Validated value
Oct. 7, 2021, 9:30 a.m. oms

1. Subjects with a history of COVID-19 who meet any of the following criteria: a) Current history of infection or have received a medical discharge for SARS-CoV 2 in the two months prior to recruitment.b) History of critical clinical picture due to COVID-19, according to your medical history or obtained during the medical interview. 2. Subject with a history of having received any dose of vaccine candidates or vaccines against SARS - CoV - 2. 3. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application.4. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine. 5. Subjects with chronic non-communicable diseases NOT controlled, according to clinical or laboratory criteria (bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid, neurological, hemolymphopoietic system diseases, liver failure, kidney failure , psychiatric illness at a psychotic level, among others). 6. Subjects with congenital or acquired immune system disease. 7. Subjects with a history of neoplastic disease. 8. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except smoking. 9. Subjects with diminished mental faculties. 10. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria). 11. Participation in another clinical trial of preventive or therapeutic intervention in the last 3 months. 12. Application of another vaccine in the last 30 days. 13. Treatment with immunomodulators in the last 30 days, eg, steroids (except for the occasional use of topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any ganmaglobulin, levamisole, heberferon, thymosin) or those who, due to their underlying disease, require treatment immunomodulator, which may coincide during the development of the study. 14. History of having received a blood transfusion or blood products in the last 3 months. 15. Subjects with difficulties in attending the planned follow-up consultations. 16. Splenectomy or splenic dysfunction. 17. Pregnancy, puerperium or lactation. 18. Subjects with tattoos in the deltoid region of both arms. 19. Subjects with positive results to the determinations of HIV, Hepatitis B Surface Antigen, Hepatitis C Antibody and VDRL Serology. (For Phase I)

1. Subjects with a history of COVID-19 who meet any of the following criteria: a) Current history of infection or have received a medical discharge for SARS-CoV 2 in the two months prior to recruitment.b) History of critical clinical picture due to COVID-19, according to your medical history or obtained during the medical interview. 2. Subject with a history of having received any dose of vaccine candidates or vaccines against SARS - CoV - 2. 3. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application.4. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine. 5. Subjects with chronic non-communicable diseases NOT controlled, according to clinical or laboratory criteria (bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid, neurological, hemolymphopoietic system diseases, liver failure, kidney failure , psychiatric illness at a psychotic level, among others). 6. Subjects with congenital or acquired immune system disease. 7. Subjects with a history of neoplastic disease. 8. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except smoking. 9. Subjects with diminished mental faculties. 10. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria). 11. Participation in another clinical trial of preventive or therapeutic intervention in the last 3 months. 12. Application of another vaccine in the last 30 days. 13. Treatment with immunomodulators in the last 30 days, eg, steroids (except for the occasional use of topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any ganmaglobulin, levamisole, heberferon, thymosin) or those who, due to their underlying disease, require treatment immunomodulator, which may coincide during the development of the study. 14. History of having received a blood transfusion or blood products in the last 3 months. 15. Subjects with difficulties in attending the planned follow-up consultations. 16. Splenectomy or splenic dysfunction. 17. Pregnancy, puerperium or lactation. 18. Subjects with tattoos in the deltoid region of both arms. 19. Subjects with positive results to the determinations of HIV, Hepatitis B Surface Antigen, Hepatitis C Antibody and VDRL Serology. (For Phase I)