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

• ClinicalTrials.gov Identifier: NCT04691947
• Recruitment Status: Completed
• First Posted: December 31, 2020
• Last Update Posted: February 14, 2023
• Sponsor: Health Institutes of Turkey
• Collaborator: TC Erciyes University
• Information provided by (Responsible Party): Health Institutes of Turkey

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: November 18, 2021
• Actual Study Completion Date: November 18, 2021

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Turkey

Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Kayseri, Turkey, 38038

Sponsors and Collaborators

Health Institutes of Turkey

TC Erciyes University

Investigators

• Principal Investigator: Zafer Sezer; Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

More Information

Publications of Results:

Ozdarendeli A, Sezer Z, Pavel STI, Inal A, Yetiskin H, Kaplan B, Uygut MA, Bayram A, Mazicioglu M, Unuvar GK, Yuce ZT, Aydin G, Aslan AF, Kaya RK, Koc RC, Ates I, Kara A. Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: Interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials. Vaccine. 2023 Jan 9;41(2):380-390. doi: 10.1016/j.vaccine.2022.10.093. Epub 2022 Nov 22.

• Responsible Party: Health Institutes of Turkey
• ClinicalTrials.gov Identifier: NCT04691947
• Other Study ID Numbers: IDEAL00420-EU01-PK537-1
• First Posted: December 31, 2020
• Last Update Posted: February 14, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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