Efficacy, Immunogenicity and Safety of Inactivated ERUCOV-VAC Compared With Placebo in COVID-19

NCT04824391 | Completed Phase 2 DMC

• 1 other identifier: IDEAL00620-EU02-PK537-3
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to determine the efficacy, immunogenicity and safety of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the efficacy and safety in prophylaxis of COVID-19. A 3rd application will be performed to approximately the half of the volunteers who were administered 3 μg/0.5 ml and who accept to be vaccinated for a 3rd time, on their month 4 visit.

Conditions

COVID-19

Keywords

COVID-19; Vaccine; Inactive; Phase 2

Outcome Measures

Primary Outcomes (3)

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

  12 months

• Neutralizing antibodies from microneutralization assay

  12 months

• Blood levels of cytokines: TNF-α, IFN-γ, IL-2, IL-4, IL-5 and IL-6

  12 months

Secondary Outcomes (1)

• Adverse events

  12 months

Study Arms (3)

3 mcg/0.5 ml Vaccine

EXPERIMENTAL

Low dose vaccine

Biological: ERUCOV-VAC 3 µg/0.5 ml Vaccine

6 mcg/0.5 ml Vaccine

EXPERIMENTAL

Medium dose vaccine

Biological: ERUCOV-VAC 6 µg/0.5 ml Vaccine

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

ERUCOV-VAC 3 µg/0.5 ml Vaccine BIOLOGICAL

Two IM applications on Days 1 and 28

3 mcg/0.5 ml Vaccine

ERUCOV-VAC 6 µg/0.5 ml Vaccine BIOLOGICAL

Two IM applications on Days 1 and 28

6 mcg/0.5 ml Vaccine

Placebo OTHER

Two IM applications on Days 1 and 28

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Non-pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy Caucasian origin
• 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
• female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination OR agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination.
• male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
• 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 and respiratory rate should be normal/acceptable.
• laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, BUN, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab should be normal/acceptable.
• antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
• body weight in relation to height and age accepted BMI range 18.5 and 32 kg/m2 - both inclusive

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.
• leukemia or neoplasm in history.
• 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
• presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases;
• disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration
• clinically significant illness within 4 weeks before the start of the study. Especially any acute or chronic illness seizures.

Sponsors & Collaborators

• Health Institutes of Turkey: lead
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University

Kayseri, 38039, 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: 36460536 RESULT

Related Links

• Paper

MeSH Terms

Conditions

COVID-19; Sedentary Behavior

Interventions

TURKOVAC; Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Zafer Sezer, Assoc.Prof.

  Co-Investigator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: February 10, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 30, 2022
• Last Updated: August 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)