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COVID-19 VaccinePhase 1NCT04838080

Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo

A Phase 1 study testing Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine and Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine in people with COVID-19 Vaccine, run by Kocak Farma at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccine
What is being tested?
Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine and Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Mar 2021to 20 Oct 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Turgay Celik, Prof. contact

+ 90 (216) 578 0000

turgay.celik@yeditepe.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Yeditepe AR-GE ve Analiz Merkezi İyi Klinik Uygulamaları Merkezi (Center for GCP)

    Istanbul, 34718

    Turgay Celik, Prof. Dr., + 90 (216) 578 0000, turgay.celik@yeditepe.edu.tr

    Meral Sonmez, Prof. Dr.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Phase 1 Study for the Determination of Safety and Immunogenicity of Different Strengths of Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.

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

Being tested
Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine, Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine, Placebo
Keywords
COVID-19, Vaccine, Inactive, Phase 1
Medical subject headings
COVID-19, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml VaccineBiological

    Two applications on Days 0 and 21

  • Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml VaccineBiological

    Two applications on Days 0 and 21

  • PlaceboBiological

    Two applications on Days 0 and 21

Study groups in NCT04838080
Study groupRoleWhat they receive
Low dose vaccineExperimentalInactivated COVID-19 Vaccine 4 µg/0.5 ml
Receives: Biological: Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine
High Dose VaccineExperimentalInactivated COVID-19 Vaccine 6 µg/0.5 ml
Receives: Biological: Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine
PlaceboPlacebo comparator0.9 % NaCl
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Questioning adverse events and examination of laboratory safety data

    Measured: From day 0 until the end of follow up period (6 months)

Secondary outcomes (3)

  1. Serum immunoglobulin G (IgG) antibody levels

    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s)

    Measured: From screening until the end of follow up period (6 months)

  2. Neutralizing antibodies

    Measurement of SARS-CoV-2-specific neutralizing antibodies

    Measured: From screening until the end of follow up period (6 months)

  3. Blood levels of cytokines

    TNF-alpha, IFN-γ, IL-2, IL-4, IL-5 and IL-6

    Measured: From screening until the end of follow up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start19 Mar 2021
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion20 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838080
Sponsor's protocol ID
ALP-2020-FZ-01-PK-537-2
Status last verified
Apr 2021
First submitted
6 Apr 2021
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine and Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine in people with COVID-19 Vaccine, run by Kocak Farma at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Turgay Celik, Prof. (+ 90 (216) 578 0000, turgay.celik@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: From day 0 until the end of follow up period (6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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