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AzTrials

COVID-19 VaccinePhase 1ERUCOV-VACNCT04691947

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

A Phase 1 study testing ERUCOV-VAC in people with COVID-19 Vaccine, run by Health Institutes of Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
ERUCOV-VAC
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Nov 2020to 18 Nov 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
  • 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);
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  • 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)

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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  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Kayseri, 38038

Other trials in Turkey (Türkiye)

About this study

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.

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.

Read the 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.

Being tested
ERUCOV-VAC, Placebo Vaccine
Keywords
COVID-19, Inactive Vaccine, Phase I
Medical subject headings
COVID-19

What participants receive

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

  • ERUCOV-VACBiological

    Vaccination on Day 0 and Day 21

  • Placebo VaccineOther

    Placebo Vaccination on Day 0 and Day 21

Study groups in NCT04691947
Study groupRoleWhat they receive
Low dose vaccineExperimentalType: Biological/Vaccine Name: ERUCOV-VAC 3 µg/0.5 ml Vaccine Intervention Description:Two applications on Days 0 and 21
Receives: Biological: ERUCOV-VAC
Medium dose vaccineExperimentalType: Biological/Vaccine Name: ERUCOV-VAC 6 µg/0.5 ml Vaccine Intervention Description: Two applications on Days 0 and 21
Receives: Biological: ERUCOV-VAC
PlaceboPlacebo comparatorPlacebo Vaccine, containing 0.9 % saline Intervention Description: Two applications on Days 0 and 21
Receives: Other: Placebo Vaccine

What is being measured

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

  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.

    Measured: 43 days

Secondary outcomes (5)

  1. Serum IgG antibody Levels

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

    Measured: 12 months

  2. Neutralizing Antibodies Levels

    Serum Neutralizing antibody levels.

    Measured: 12 months

  3. TNF-alpha Levels

    Serum TNF-alpha levels.

    Measured: 12 months

  4. Interferon Levels

    Serum IFN-γ levels.

    Measured: 12 months

  5. Interleukine Levels

    Serum IL-2, -4, -5, -6 levels.

    Measured: 12 months

Timeline

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

  1. First posted31 Dec 2020
  2. Study start5 Nov 2020
  3. Primary completion18 Nov 2021
  4. Study completion18 Nov 2021

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04691947
Sponsor's protocol ID
IDEAL00420-EU01-PK537-1
Acronym
ERUCOV-VAC
Status last verified
Feb 2023
First submitted
14 Nov 2020
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 36460536

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ERUCOV-VAC in people with COVID-19 Vaccine, run by Health Institutes of Turkey 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 13 inclusion and 11 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: finished, as of the sponsor's last update on 14 Feb 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and tolerability of the COVID-19 vaccine (time frame: 43 days). 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 NCT04691947, which also lists 1 linked publication.

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 14 Feb 2023.

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