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Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults (COVID-19)

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ClinicalTrials.gov Identifier: NCT04818281
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
The Scientific and Technological Research Council of Turkey
MonitorCRO
Nobel Pharmaceuticals
Information provided by (Responsible Party):
Ihsan GURSEL, PhD, Prof., The Scientific and Technological Research Council of Turkey

Study Description
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Brief Summary:
This is a VLP SARS-CoV-2 vaccine study of a vaccine developed in Turkey and manufactured according to Good Manufacturing Practices (GMP) requirements. Preclinical toxicology studies on experimental animals are to be concluded. The purpose of this Phase I study is to examine the safety, tolerability, and immunogenicity of the protective VLP vaccine against SARS-CoV-2, which will be administered by a double-blind, randomized method, in two different doses (low dose and high dose).

Condition or disease Intervention/treatment Phase
Covid19 Biological: SARS-CoV-2 VLP Vaccine Biological: Placebo Phase 1

Detailed Description:

This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective VLP vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine will be defined as a cohort in itself, with vaccine administration to 12 participants and placebo administration to 6 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and study will continue accordingly.

The study will be completed in 12 months.

All injections will be done subcutaneously.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Prevention
Official Title: Phase I Study Evaluating the Basic Pharmacological and Toxicological Effects of the Protective VLP Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously, in Two Different Dosages.
Actual Study Start Date : March 27, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-Dose Group (Group A)
12 participants will receive 3.75 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
 Biological: SARS-CoV-2 VLP Vaccine
VLP adjuvanted vaccine
Experimental: High-Dose Group (Group B)
12 participants will receive 15 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
 Biological: SARS-CoV-2 VLP Vaccine
VLP adjuvanted vaccine
Placebo Comparator: Placebo Group
12 participants will receive 1 ml of 0.9% sodium chloride (NaCl)
 Biological: Placebo
0.9% NaCl


Outcome Measures
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Primary Outcome Measures :
  1. Acute adverse events (AEs) [ Time Frame: 24 hours ]
    Frequency of acute AEs in all dosage groups

  2. Solicited local and systemic adverse events (AEs) [ Time Frame: 6 days ]
    Frequency of local and systemic AEs in all dosage groups

  3. Unsolicited local and systemic adverse events (AEs) [ Time Frame: 28 days ]
    Frequency of local and systemic AEs in all dosage groups


Secondary Outcome Measures :
  1. Specific antibody (IgG) response [ Time Frame: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose ]
    IgG type antibody titers against anti-Spike protein of SARS-CoV-2 (by ELISA)

  2. Neutralizing antibody response [ Time Frame: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose ]
    Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2

  3. Cellular immune response (IL-4) [ Time Frame: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose ]
    ELISPOT: Interleukin-4 (IL4) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein

  4. Cellular immune response (IFN-γ) [ Time Frame: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose ]
    ELISPOT: Interferon-γ (IFN-γ) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be eligible for the study, each participant must satisfy all the following criteria:

  1. Healthy participants between 18-59 years of age,
  2. Sign an informed consent document,
  3. Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
  4. Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
  5. Able to comply with the study protocol during the study period,
  6. Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
  7. Body temperature <37.2 C,
  8. Body mass index 18-35 kg/m2,
  9. Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose,
  10. Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
  11. Female participants who are not pregnant or who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination,
  12. Male participants who will be able to have appropriate contraception methods for 6 months after vaccination,

Exclusion Criteria:

Participants with any of the following criteria will be excluded:

  1. History of seizure, encephalopathy or psychosis,
  2. History of allergic reactions to any known vaccine or to any component of the study vaccine,
  3. Pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months,
  4. Active infection signs or body temperature >37.2 C,
  5. History of SARS-CoV-2 infection,
  6. Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
  7. Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
  8. Congenital or acquired angioedema,
  9. Diagnosis of immunodeficiency,
  10. Diagnosis of bleeding diathesis,
  11. Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
  12. Those who received blood and blood product transfusions in the last 6 months,
  13. Those on any vaccine program or experimental medication within 1 month prior to the study,
  14. History of any live vaccine administration within 1 month prior to the study,
  15. History of any inactive vaccine administration within 1 month prior to the study,
  16. Use of active tuberculosis treatment,
  17. According to the investigator's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the patient's compliance with the study will be excluded from the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04818281


Contacts
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Contact: Recep S SENTURK, MD (+90) 505 385 00 65 drselim32@gmail.com

Locations
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Turkey
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center Recruiting
Ankara, Turkey, 06200
Contact: Recep S SENTURK, MD    +905053850065    drselim32@gmail.com   
Sponsors and Collaborators
Ihsan GURSEL, PhD, Prof.
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
The Scientific and Technological Research Council of Turkey
MonitorCRO
Nobel Pharmaceuticals
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ihsan GURSEL, PhD, Prof., PhD, Prof, The Scientific and Technological Research Council of Turkey
ClinicalTrials.gov Identifier: NCT04818281    
Other Study ID Numbers: VLP-58-1023-Al-K3
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ihsan GURSEL, PhD, Prof., The Scientific and Technological Research Council of Turkey:
Virus-like Particles
SARS-CoV-2