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

Sponsor
Ihsan GURSEL, PhD, Prof. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04962893
Collaborator
The Scientific and Technological Research Council of Turkey (Other), Nobel Pharmaceuticals (Industry), MonitorCRO (Industry)
330
Enrollment
3
Locations
3
Arms
14.2
Anticipated Duration (Months)
110
Patients Per Site
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, parallel dose assigned, double blind, multi center, Phase II study assessing the efficacy, safety, and immunogenicity of VLP vaccine (Authentic and Alpha variants) in adults between 18 and 59 years who are healthy or have medically stable chronic diseases and who have no known history of SARS-CoV-2 infection

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: SARS-CoV-2 VLP Vaccine-Wuhan
  • Biological: SARS-CoV-2 VLP Vaccine-Alpha (British) variant
  • Biological: SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant
Phase 2

Detailed Description

The primary objective of the study is to evaluate the humoral and cellular immune response of VLP vaccine candidates (harboring M, N, E, and HexaPro S antigens of the virus), as an efficacy criteria.

Approximately 330 subjects will be randomized in a 1:1:1 ratio to receive two doses of 40 mcg VLP vaccine for Wuhan (n=110) or 40 mcg VLP vaccine for Alpha (British) variant (n=110) or 40 mcg VLP vaccine for Wuhan+Alpha variant (n=110) 21 days apart.

The study will be completed in 14 months.

All injections will be done subcutaneously.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blinded
Primary Purpose:
Prevention
Official Title:
Phase II Study to Assess the Safety, Efficacy, and Immunogenicity of Authentic SARS-CoV-2 or Alpha Variant Spike Containing VLP Vaccines and Their Combination for the Prevention of COVID-19 in Healthy Adult Volunteers (SAVE STUDY)
Actual Study Start Date :
Jun 26, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: VLP-Wuhan group (Group V1)

110 participants will receive 40 mcg of Alum adsorbed VLP vaccine for Wuhan adjuvanted with K3-CpGODN (1 ml), in two doses 21 days apart.

Biological: SARS-CoV-2 VLP Vaccine-Wuhan
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
Other Names:
  • Authentic VLP Vaccine
  • Experimental: VLP-Alpha (British) variant group (Group V2)

    110 participants will receive 40 mcg of Alum adsorbed VLP vaccine for Alpha variant adjuvanted with K3-CpGODN (1 ml), in two doses 21 days apart.

    Biological: SARS-CoV-2 VLP Vaccine-Alpha (British) variant
    Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
    Other Names:
  • Alpha Variant VLP Vaccine
  • Experimental: VLP-Wuhan+Alpha group (Group V3)

    110 participants will receive 40 mcg of Alum adsorbed VLP vaccine for Wuhan and Alpha variant adjuvanted with K3-CpGODN (1 ml), in two doses 21 days apart. Initial vaccination with Wuhan followed by a booster of Alpha variant.

    Biological: SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant
    Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants
    Other Names:
  • Combination of Authentic and Alpha VLP Vaccine
  • Outcome Measures

    Primary Outcome Measures

    1. Comparison of efficacy [On Day 14 after booster dose administration]

      Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).

    2. Comparison of efficacy [On Day 28 after booster dose administration]

      Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).

    3. Specific antibody (IgG) response [On Day 14 after booster dose administration]

      SARS-CoV-2 Spike/S1 or RBD antibody titers

    4. Specific antibody (IgG) response [On Day 28 after booster dose administration]

      SARS-CoV-2 Spike/S1 or RBD antibody titers

    5. Neutralizing antibody response [On Day 14 after booster dose administration]

      Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2

    6. Neutralizing antibody response [On Day 28 after booster dose administration]

      Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2

    7. Cellular immune response [Before first dose administration, on Day 14 after booster dose administration]

      ELISPOT: Interferon-γ (IFN-γ) positive level of T-cells

    Secondary Outcome Measures

    1. Adverse events (AEs) [Until Month 12 after booster dose administration]

      Local and systemic AEs in all vaccine groups

    2. Serious adverse events (SAEs) [Until Month 12 after booster dose administration]

      SAEs in all vaccine groups

    3. Specific antibody (IgG) response [Before first and booster dose administration, at Month 3, Month 6, Month 9 and Month 12 after booster dose]

      SARS-CoV-2 Spike/S1 or RBD antibody titers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    To be eligible for the study, each participant must satisfy all the following criteria:
    1. Female and/or male participant who is informed and about his/her participation and who agrees to give his/her written informed consent.

    2. Aged between 18 and 59 years.

    3. Negative Immunoglobulin G (IgG)/Immunoglobulin M (IgM) antibody for COVID-19.

    4. Negative COVID-19 quantitative polymerase chain reaction (qPCR) test result.

    5. Able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.

    6. Negative blood test for hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) at screening period.

    7. Body temperature < 37.2°C.

    8. Body Mass Index (BMI) ranged between 18-35 kg/m2.

    9. Clinical laboratory test results within the reference range of the laboratory or clinically non-significant (complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea, creatinine, and fasting glucose) or any laboratory parameters defined in the study protocol.

    10. Good general health as determined by physical examination, laboratory screening, and review of medical history within 14 days prior to participation.

    11. Female participants of childbearing potential may be enrolled in the study if the subject fulfils all the following criteria:

    • Have a negative pregnancy test on the day of screening and prior to each study vaccine administration.

    • Use an effective contraceptive method for at least 30 days prior to first dose of study vaccine and agree to continue using one highly effective form of birth control through 6 months after the administration of the last dose of study vaccine.

    1. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to Screening without an alternative medical cause) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

    2. Male participants who agree to use an effective contraceptive method during the study period and until 6 months after the last dose of study vaccine.

    Exclusion Criteria:
    Participants with any of the following criteria will be excluded:
    1. History of laboratory-confirmed SARS-COV-2 infection.

    2. History of seizures, encephalopathy, or psychosis.

    3. Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to any vaccine or study vaccine and/or any other excipients of the vaccine.

    4. Pregnant, breastfeeding or planning to become pregnant within 6 months after the study vaccine administration.

    5. Suspected active infection or other acute illness, including fever > 37.2°C.

    6. Any presence of clinical relevance of cardiovascular disease (including but not limited to arrythmia, myocardial infarction, uncontrolled hypertension, coronary artery disease, or congestive heart failure).

    7. Any presence of clinical relevance of serious chronic disease [asthma, diabetes, thyroid diseases etc.).

    8. Any presence of clinical relevance of congenital or acquired angioedema.

    9. Diagnosis of immunodeficiency.

    10. Diagnosis of bleeding diathesis.

    11. Use of immunosuppressive medications, anti-allergic therapy, cytotoxic therapy, inhaler corticosteroids (excluding allergic rhinitis or topical steroid ointments).

    12. Those who received blood/plasma products or immunoglobulins and/or blood transfusion within the last 6 months.

    13. Those who participated in another vaccine study or received an investigational/experimental drug within 1 month prior to study entry.

    14. History of any live vaccine within 1 month prior to study participation.

    15. History of any inactivated vaccine within 1 month prior to study participation.

    16. Use of active tuberculosis treatment.

    17. According to the investigator's judgement, those who have any condition (medical, psychological, social, etc.) that may impair the subject's compliance with the study

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study CenterAnkaraTurkey06200
    2Health Sciences University İstanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research HospitalİstanbulTurkey34020
    3Kocaeli University Research and Application Hospital Infectious Disease and Clinical Microbiology DepartmentKocaeliTurkey41380

    Sponsors and Collaborators

    • Ihsan GURSEL, PhD, Prof.
    • The Scientific and Technological Research Council of Turkey
    • Nobel Pharmaceuticals
    • MonitorCRO

    Investigators

    • Principal Investigator: Fevzi ALTUNTAS, HEAD OF ONCOLOGY HOSPITAL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ihsan GURSEL, PhD, Prof., Co- Principal Investigator, The Scientific and Technological Research Council of Turkey
    ClinicalTrials.gov Identifier:
    NCT04962893
    Other Study ID Numbers:
    • VLP-58-1023-Al-K3-PII
    First Posted:
    Jul 15, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Jul 1, 2021
    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., Co- Principal Investigator, The Scientific and Technological Research Council of Turkey
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021