Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04838080
Other study ID # ALP-2020-FZ-01-PK-537-2
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 19, 2021
Est. completion date October 20, 2021

Study information

Verified date April 2021
Source Kocak Farma
Contact Turgay Celik, Prof.
Phone + 90 (216) 578 0000
Email turgay.celik@yeditepe.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the safety and immunogenicity of two different strengths (4 µg and 6 µg) of an inactivated COVID-19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date October 20, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 (ß-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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Koçak-19 Inaktif Adjuvanli COVID-19 Vaccine 4 µg/0.5 ml Vaccine
Two applications on Days 0 and 21
Koçak-19 Inaktif Adjuvanli COVID-19 Vaccine 6 µg/0.5 ml Vaccine
Two applications on Days 0 and 21
Placebo
Two applications on Days 0 and 21

Locations

Country Name City State
Turkey Yeditepe AR-GE ve Analiz Merkezi Iyi Klinik Uygulamalari Merkezi (Center for GCP) Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Kocak Farma

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Questioning adverse events and examination of laboratory safety data From day 0 until the end of follow up period (6 months)
Secondary Serum immunoglobulin G (IgG) antibody levels Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) From screening until the end of follow up period (6 months)
Secondary Neutralizing antibodies Measurement of SARS-CoV-2-specific neutralizing antibodies From screening until the end of follow up period (6 months)
Secondary Blood levels of cytokines TNF-alpha, IFN-?, IL-2, IL-4, IL-5 and IL-6 From screening until the end of follow up period
See also
  Status Clinical Trial Phase
Completed NCT05049226 - Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine Phase 2
Recruiting NCT05998824 - COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease N/A
Recruiting NCT05097053 - A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19 Phase 4
Active, not recruiting NCT05463419 - A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose. Phase 2/Phase 3
Active, not recruiting NCT05293223 - Phase IIB Study of Recombinant Novel Coronavirus Vaccine Phase 2
Completed NCT04691947 - Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC Phase 1
Completed NCT05288231 - Cardiac Manifestation in Adolescent After Pfizer COVID-19 Injection in Thailand
Completed NCT04546841 - Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults Phase 1
Terminated NCT04963790 - Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase Covid-19 Vaccine Uptake N/A
Completed NCT05216601 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19 Phase 1
Completed NCT04566276 - ChulaCov19 Vaccine in Healthy Adults Phase 1/Phase 2
Completed NCT04915820 - Iron and COVID-19 Vaccine Response N/A
Completed NCT05268679 - Covid-19 Vaccine Response in Heart Transplant Recipients
Completed NCT04898946 - Serological Response to mRNA and Inactivated COVID-19 Vaccine in Health Care Workers in Hong Kong
Recruiting NCT05869968 - SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Active, not recruiting NCT05197712 - Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease Phase 1
Recruiting NCT05553743 - Researchers at UC San Diego Are Learning About the Benefits of Human Milk and How it Influences Infant and Child Health
Active, not recruiting NCT05188469 - Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers Phase 1/Phase 2
Completed NCT04764422 - Assess the Safety and Immunogenicity of NDV-HXP-S Vaccine in Thailand Phase 1/Phase 2
Recruiting NCT05822219 - Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases N/A