NCT04691947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

November 14, 2020

Last Update Submit

February 10, 2023

Conditions

COVID-19 Vaccine

Keywords

COVID-19Inactive VaccinePhase I

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Serum IgG antibody Levels

    12 months

  • Neutralizing Antibodies Levels

    12 months

  • TNF-alpha Levels

    12 months

  • Interferon Levels

    12 months

  • Interleukine Levels

    12 months

Study Arms (3)

Low dose vaccine

EXPERIMENTAL

Type: Biological/Vaccine Name: ERUCOV-VAC 3 µg/0.5 ml Vaccine Intervention Description:Two applications on Days 0 and 21

Biological: ERUCOV-VAC

Medium dose vaccine

EXPERIMENTAL

Type: Biological/Vaccine Name: ERUCOV-VAC 6 µg/0.5 ml Vaccine Intervention Description: Two applications on Days 0 and 21

Biological: ERUCOV-VAC

Placebo

PLACEBO COMPARATOR

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

Other: Placebo Vaccine

Interventions

ERUCOV-VACBIOLOGICAL

Vaccination on Day 0 and Day 21

Low dose vaccineMedium dose vaccine
Placebo VaccineOTHER

Placebo Vaccination on Day 0 and Day 21

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsNon-pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kayseri, 38038, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 36460536RESULT

MeSH Terms

Conditions

COVID-19

Interventions

TURKOVAC

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zafer Sezer

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2020

First Posted

December 31, 2020

Study Start

November 5, 2020

Primary Completion

November 18, 2021

Study Completion

November 18, 2021

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)