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

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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Vaccine
• Intervention / Treatment: Biological: ERUCOV-VAC; Other: Placebo Vaccine

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38038
    • Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IgG antibody Levels	Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s).	12 months
Neutralizing Antibodies Levels	Serum Neutralizing antibody levels.	12 months
TNF-alpha Levels	Serum TNF-alpha levels.	12 months
Interferon Levels	Serum IFN-γ levels.	12 months
Interleukine Levels	Serum IL-2, -4, -5, -6 levels.	12 months

Collaborators and Investigators

• Sponsor: Health Institutes of Turkey
• Collaborators: TC Erciyes University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Paper

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2020
• Primary Completion (ACTUAL): November 18, 2021
• Study Completion (ACTUAL): November 18, 2021

Study Registration Dates

• First Submitted: November 14, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Phase I; Inactive Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IDEAL00420-EU01-PK537-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No