Clinical trial: Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo (NCT04838080)

Eligibility criteria:
Inclusion Criteria:

          -  healthy Caucasian origin

          -  male or female

          -  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

          -  female participants of childbearing potential (defined as any female who has
             experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral
             tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at
             least 12 consecutive months) must agree to be heterosexually inactive through 12
             months after the first vaccination OR agree to consistently use any of the described
             methods of contraception from through 12 months after the first vaccination.

          -  male subjects agree to refrain from sperm donation from the time of first vaccination
             until 3 months after last vaccination

          -  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 leucocytes 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 = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2)

          -  Informed consent given in written form according to section 15.3.

          -  agree not to participate in another vaccine clinical trial until the end of the study.

          -  agree to remain in the study area for the entire duration of the study.

        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.

          -  leukemia or neoplasm in history.

          -  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

          -  presence or a history of clinically significant cardiovascular, renal, hepatic,
             pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological,
             psychiatric or other major diseases;

          -  disruption of platelets or other blood clotting disorders, which may cause
             contraindications to intramuscular administration

          -  clinically significant illness within 4 weeks before the start of the study.
             Especially any acute or chronic illness seizures.

          -  any regular intake or administration of any prescribed systemic or topical medication
             within 2 weeks prior to the start of the study; in the case of intake or
             administration of any prescribed systemic or topical medication within 4 weeks before
             the start of the study because of an insignificant illness, this should be stated in
             the CRF.

          -  intake or administration of OTC medication (including herbal remedies) which may have
             an effect on the study according to the investigator within 2 weeks prior to the start
             of the study

          -  volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any
             other investigational drug within 4 weeks prior to the first study product
             administration

          -  concomitant intake or administration of any systemic or topical drugs (including
             herbal remedies) on the application days

          -  treatment with any investigational drug (i.e., drug not yet approved) in the last 4
             weeks before beginning of the trial

          -  medication with drugs known to alter organs or systems such as barbiturates,
             phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks)

          -  donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any
             amount within the last month (4 weeks)

          -  supine blood pressure, after resting for 5 min, higher than 140/90 or lower than
             100/60 mmHg

          -  supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min

          -  supine respiratory rate, after resting for 5 min, outside the range of 15 - 18
             breathings / min

          -  any clinically significant abnormality of the ECG (12 leads) recorded in rest

          -  laboratory values (appendix 5) outside normal range with clinical relevance at entry
             examination

          -  alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of
             alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine
             or 50 ml of spirits) or recovered alcoholics

          -  caffeine abuse i.e. regular use of more than 750 mg/day caffeine

          -  alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke,
             chocolate) and fruit-juice from 24 hours prior to each application until the end of
             hospitalization

          -  grapefruit products from 7 days prior to the first application until the end of
             hospitalization

          -  smoking of more than 10 cigarettes or equivalent per day, no smoking allowed during
             hospitalization in the clinical unit

          -  vegetarian or any special diet due to any reason

          -  knowledge to have any type of parenterally transmitted hepatitis or carrier of the
             HBsAg (HBsAg test positive)

          -  HIV-Ab test positive

          -  Test on anti-HCV antibodies positive

          -  positive drug screen or history of drug abuse (amphetamines, cannabinoids,
             benzodiazepines, cocaine, opioids, barbiturates)

          -  legal incapacity and/or other circumstances rendering the subject unable to understand
             the nature, scope and possible consequences of the study

          -  evidence of an uncooperative attitude.
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