Clinical trial: Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC (NCT04691947)

Eligibility criteria:
Inclusion Criteria:

          -  healthy Caucasian origin

          -  age between 18 and 55 years

          -  accepting not to participate in another COVID-19 vaccine study until the end of the
             study

          -  volunteers who do not plan to get a child in the next one year; the volunteer and the
             partner should use a reliable form of contraception (abstinence, condom, birth control
             implant, birth control pills used or IUD used by the partner) during the study for at
             least 1 year

          -  participants must refrain from blood or plasma donation from the time of first
             vaccination until 3 months after last vaccination

          -  the outcome of the following examinations should be clinically insignificant: medical
             and surgical history (hypo-, hypertension, allergy, other diseases, major surgery,
             micturition, defecation, sleep, illness within the last 4 weeks prior to the start of
             the trial);

          -  life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special
             diet, drug abuse) should be normal/acceptable

          -  body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ECG should
             be normal/acceptable.

          -  physical examination (general state and abnormal findings per system:
             endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose,
             throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital,
             musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be
             normal/acceptable

          -  laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride,
             total protein, albumin, glucose, creatinine, BUN, uric acid, total bilirubin, direct
             and indirect bilirubin, lipid panel (total cholesterol, triglyceride, HDL, LDL), AST,
             ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, leukocytes, platelet count,
             prothrombin time (PT) and activated partial thromboplastin time (aPTT); HBsAg, HIV-Ab,
             HCV-Ab; urine examination: urine color, appearance, specific gravity, pH, protein,
             glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if
             erythrocytes or leukocytes are out of the limits ) should be normal/acceptable.

          -  antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.

          -  drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine,
             opioids, barbiturates)

          -  normal body weight in relation to height and age according to BMI (accepted range 18.5
             and 30 kg/m2)

        Exclusion Criteria:

          -  women with a positive blood (β-HCG) pregnancy test

          -  lactating women

          -  history of COVID-19 infection or showing COVID-19 infection symptoms

          -  having had contact to people with known COVID-19 infection in the last 14 days

          -  having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having
             aches and pains, nasal congestion, runny nose, sore throat and diarrhea.

          -  positive real time RT-PCR COVID-19 test.

          -  persons with autoimmune diseases

          -  allergic diathesis or any clinically significant allergic disease (i.e. asthma)

          -  any condition that might impair the immune response

          -  recent or current immunosuppressive medication

          -  any other vaccine application 30 days before the first dose
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction