Efficacy, Immunogenicity and Safety of Inactivated ERUCOV-VAC Compared With Placebo in COVID-19

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 250

Inclusion Criteria

healthy Caucasian origin
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 and respiratory rate should be normal/acceptable.
laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, BUN, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab should be normal/acceptable.
antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
body weight in relation to height and age accepted BMI range 18.5 and 32 kg/m2 - both inclusive

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
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
smoking of more than 10 cigarettes or equivalent per day, no smoking before application
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
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
6 mcg/0.5 ml Vaccine	ERUCOV-VAC 6 µg/0.5 ml Vaccine	Medium dose vaccine
3 mcg/0.5 ml Vaccine	ERUCOV-VAC 3 µg/0.5 ml Vaccine	Low dose vaccine

Primary Outcome Measures

Name	Time	Method
Serum IgG antibody levels specific for the SARS-CoV- 2 rS protein antigen(s)	12 months
Neutralizing antibodies from microneutralization assay	12 months
Blood levels of cytokines: TNF-α, IFN-γ, IL-2, IL-4, IL-5 and IL-6	12 months

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 months

Efficacy, Immunogenicity and Safety of Inactivated ERUCOV-VAC Compared With Placebo in COVID-19

Recruitment & Eligibility

Study & Design

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