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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04962893
Recruitment Status : Completed
First Posted : July 15, 2021
Last Update Posted : May 31, 2022
Sponsor:
Collaborators:
The Scientific and Technological Research Council of Turkey
Nobel Pharmaceuticals
MonitorCRO
Information provided by (Responsible Party):
Ihsan GURSEL, PhD, Prof., The Scientific and Technological Research Council of Turkey

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 disease Intervention/treatment Phase
Covid19 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 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 : June 26, 2021
Actual Primary Completion Date : January 16, 2022
Actual Study Completion Date : January 16, 2022


Arm Intervention/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 Name: 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 Name: 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 Name: Combination of Authentic and Alpha VLP Vaccine




Primary Outcome Measures :
  1. Comparison of efficacy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: On Day 14 after booster dose administration ]
    SARS-CoV-2 Spike/S1 or RBD antibody titers

  4. Specific antibody (IgG) response [ Time Frame: On Day 28 after booster dose administration ]
    SARS-CoV-2 Spike/S1 or RBD antibody titers

  5. Neutralizing antibody response [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Until Month 12 after booster dose administration ]
    Local and systemic AEs in all vaccine groups

  2. Serious adverse events (SAEs) [ Time Frame: Until Month 12 after booster dose administration ]
    SAEs in all vaccine groups

  3. Specific antibody (IgG) response [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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.
  12. 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).
  13. 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

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): NCT04962893


Locations
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Turkey
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center
Ankara, Turkey, 06200
Health Sciences University İstanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
İstanbul, Turkey, 34020
Kocaeli University Research and Application Hospital Infectious Disease and Clinical Microbiology Department
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Ihsan GURSEL, PhD, Prof.
The Scientific and Technological Research Council of Turkey
Nobel Pharmaceuticals
MonitorCRO
Investigators
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Principal Investigator: Fevzi ALTUNTAS HEAD OF ONCOLOGY HOSPITAL
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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: July 15, 2021    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022

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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 harboring S, M, N, E antigens
SARS-CoV-2
K3-CpG ODN
Alum
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs