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

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ClinicalTrials.gov Identifier: NCT04691947
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
TC Erciyes University
Information provided by (Responsible Party):
Health Institutes of Turkey

Brief Summary:
The objective is to determine the safety and immunogenicity of two different strengths (3 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.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Biological: ERUCOV-VAC Other: Placebo Vaccine Phase 1

Detailed Description:
This is a double-blind, double dose, parallel, randomized vaccination study. Each subject will receive in random order a double intramuscular dose of ERUCOV-VAC 3 µg/0.5 ml Vaccine, ERUCOV-VAC 6 µg/0.5 ml Vaccine or 0.5 ml of placebo Vaccine according to a sequence determined by randomization, on Day 0 (1st vaccination) and Day 21 (2nd vaccination).In total 34 healthy subjects of both genders will be monitored for one year in total, after Day 43 the study will be unblinded and the volunteers who took placebo vaccine will be released from the study. The most important evaluation will be performed on Day 43 after the first vaccine dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1 Study for the Determination of Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 15, 2022

Arm Intervention/treatment
Experimental: Low dose vaccine
Type: Biological/Vaccine Name: ERUCOV-VAC 3 µg/0.5 ml Vaccine Intervention Description:Two applications on Days 0 and 21
Biological: ERUCOV-VAC
Vaccination on Day 0 and Day 21

Experimental: Medium dose vaccine
Type: Biological/Vaccine Name: ERUCOV-VAC 6 µg/0.5 ml Vaccine Intervention Description: Two applications on Days 0 and 21
Biological: ERUCOV-VAC
Vaccination on Day 0 and Day 21

Placebo Comparator: Placebo
Placebo Vaccine, containing 0.9 % saline Intervention Description: Two applications on Days 0 and 21
Other: Placebo Vaccine
Placebo Vaccination on Day 0 and Day 21




Primary Outcome Measures :
  1. To assess the safety and tolerability of the COVID-19 vaccine [ Time Frame: 43 days ]
    The number and proportion of subjects with adverse events observed until Day 43 post 1st vaccination are declared to be primary target variables.


Secondary Outcome Measures :
  1. Serum IgG antibody Levels [ Time Frame: 12 months ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s).

  2. Neutralizing Antibodies Levels [ Time Frame: 12 months ]
    Serum Neutralizing antibody levels.

  3. TNF-alpha Levels [ Time Frame: 12 months ]
    Serum TNF-alpha levels.

  4. Interferon Levels [ Time Frame: 12 months ]
    Serum IFN-γ levels.

  5. Interleukine Levels [ Time Frame: 12 months ]
    Serum IL-2, -4, -5, -6 levels.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Non-pregnant women
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691947


Contacts
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Contact: ZAFER SEZER +90352 207 66 66 ext 24405 drzafersezer@gmail.com
Contact: AYKUT Özdarendeli +90 352 437 9300 aozdarendelia@gmail.com

Locations
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Turkey
Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP) Recruiting
Kayseri, Turkey, 38038
Sub-Investigator: Ahmet İnal         
Sub-Investigator: M.Mümtaz Mazıcıoğlu         
Sub-Investigator: Adnan Bayram         
Sub-Investigator: Zeynep Türe Yüce         
Sub-Investigator: Aykut Özdarendeli         
Sponsors and Collaborators
Health Institutes of Turkey
TC Erciyes University
Investigators
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Principal Investigator: Zafer Sezer Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
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Responsible Party: Health Institutes of Turkey
ClinicalTrials.gov Identifier: NCT04691947    
Other Study ID Numbers: IDEAL00420-EU01-PK537-1
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Health Institutes of Turkey:
COVID-19
Inactive Vaccine
Phase I
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases