Study of a Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine
COVID-19
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)
1 other identifier
interventional
349
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Jun 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2021
CompletedFirst Submitted
Initial submission to the registry
July 12, 2021
CompletedFirst Posted
Study publicly available on registry
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2022
CompletedMay 31, 2022
May 1, 2022
7 months
July 12, 2021
May 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Comparison of efficacy
Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).
On Day 14 after booster dose administration
Comparison of efficacy
Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).
On Day 28 after booster dose administration
Specific antibody (IgG) response
SARS-CoV-2 Spike/S1 or RBD antibody titers
On Day 14 after booster dose administration
Specific antibody (IgG) response
SARS-CoV-2 Spike/S1 or RBD antibody titers
On Day 28 after booster dose administration
Neutralizing antibody response
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
On Day 14 after booster dose administration
Neutralizing antibody response
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
On Day 28 after booster dose administration
Cellular immune response
ELISPOT: Interferon-γ (IFN-γ) positive level of T-cells
Before first dose administration, on Day 14 after booster dose administration
Secondary Outcomes (3)
Adverse events (AEs)
Until Month 12 after booster dose administration
Serious adverse events (SAEs)
Until Month 12 after booster dose administration
Specific antibody (IgG) response
Before first and booster dose administration, at Month 3, Month 6, Month 9 and Month 12 after booster dose
Study Arms (3)
VLP-Wuhan group (Group V1)
EXPERIMENTAL110 participants will receive 40 mcg of Alum adsorbed VLP vaccine for Wuhan adjuvanted with K3-CpGODN (1 ml), in two doses 21 days apart.
VLP-Alpha (British) variant group (Group V2)
EXPERIMENTAL110 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.
VLP-Wuhan+Alpha group (Group V3)
EXPERIMENTAL110 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.
Interventions
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants
Eligibility Criteria
You may qualify if:
- To be eligible for the study, each participant must satisfy all the following criteria:
- Female and/or male participant who is informed and about his/her participation and who agrees to give his/her written informed consent.
- Aged between 18 and 59 years.
- Negative Immunoglobulin G (IgG)/Immunoglobulin M (IgM) antibody for COVID-19.
- Negative COVID-19 quantitative polymerase chain reaction (qPCR) test result.
- Able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Negative blood test for hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) at screening period.
- Body temperature \< 37.2°C.
- Body Mass Index (BMI) ranged between 18-35 kg/m2.
- 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.
- Good general health as determined by physical examination, laboratory screening, and review of medical history within 14 days prior to participation.
- 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.
- 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).
- +1 more criteria
You may not qualify if:
- Participants with any of the following criteria will be excluded:
- History of laboratory-confirmed SARS-COV-2 infection.
- History of seizures, encephalopathy, or psychosis.
- 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.
- Pregnant, breastfeeding or planning to become pregnant within 6 months after the study vaccine administration.
- Suspected active infection or other acute illness, including fever \> 37.2°C.
- 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).
- Any presence of clinical relevance of serious chronic disease \[asthma, diabetes, thyroid diseases etc.).
- Any presence of clinical relevance of congenital or acquired angioedema.
- Diagnosis of immunodeficiency.
- Diagnosis of bleeding diathesis.
- Use of immunosuppressive medications, anti-allergic therapy, cytotoxic therapy, inhaler corticosteroids (excluding allergic rhinitis or topical steroid ointments).
- Those who received blood/plasma products or immunoglobulins and/or blood transfusion within the last 6 months.
- Those who participated in another vaccine study or received an investigational/experimental drug within 1 month prior to study entry.
- History of any live vaccine within 1 month prior to study participation.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ihsan GURSEL, PhD, Prof.lead
- The Scientific and Technological Research Council of Turkeycollaborator
- Nobel Pharmaceuticalscollaborator
- MonitorCROcollaborator
Study Sites (3)
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center
Ankara, 06200, Turkey (Türkiye)
Health Sciences University İstanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, 34020, Turkey (Türkiye)
Kocaeli University Research and Application Hospital Infectious Disease and Clinical Microbiology Department
Kocaeli, 41380, Turkey (Türkiye)
Related Publications (1)
Yilmaz IC, Ipekoglu EM, Golcuklu BS, Bildik T, Aksoy AGB, Evcili I, Turay N, Surucu N, Bulbul A, Guvencli N, Yildirim M, Canavar Yildirim T, Atalay YA, Abras I, Ceylan Y, Ozsurekci Y, Tigen ET, Korten V, Gursel M, Gursel I. A phase I/II study of CpG/alum-adjuvanted mammalian-derived quadruple antigen carrying virus-like particle COVID-19 vaccine. Vaccine. 2025 Mar 7;49:126787. doi: 10.1016/j.vaccine.2025.126787. Epub 2025 Jan 31.
PMID: 39892108DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fevzi ALTUNTAS
HEAD OF ONCOLOGY HOSPITAL
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blinded
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Co- Principal Investigator
Study Record Dates
First Submitted
July 12, 2021
First Posted
July 15, 2021
Study Start
June 26, 2021
Primary Completion
January 16, 2022
Study Completion
January 16, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05