AzTrials
AzTrials

Covid19Phase 2COVID-19NCT04962893

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

A Phase 2 study testing SARS-CoV-2 VLP Vaccine-Wuhan, SARS-CoV-2 VLP Vaccine-Alpha (British) variant and SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant in people with Covid19, run by Ihsan GURSEL, PhD, Prof. at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
SARS-CoV-2 VLP Vaccine-Wuhan, SARS-CoV-2 VLP Vaccine-Alpha (British) variant and SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
3 sitesTurkey (Türkiye)
Study dates
26 Jun 2021to 16 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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).
  • 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.

Who cannot join

  • 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.
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  • 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.
  • History of any inactivated vaccine within 1 month prior to study participation.
  • Use of active tuberculosis treatment.
  • 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

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites

  • Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center

    Ankara, 06200

  • Health Sciences University İstanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

    Istanbul, 34020

  • Kocaeli University Research and Application Hospital Infectious Disease and Clinical Microbiology Department

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

About this study

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)

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

Read the 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.

Conditions
Covid19
Being tested
SARS-CoV-2 VLP Vaccine-Wuhan, SARS-CoV-2 VLP Vaccine-Alpha (British) variant, SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant
Keywords
Virus-like Particles harboring S, M, N, E antigens, SARS-CoV-2, K3-CpG ODN, Alum
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 VLP Vaccine-WuhanBiological

    Also called Authentic VLP Vaccine

    Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus

  • SARS-CoV-2 VLP Vaccine-Alpha (British) variantBiological

    Also called Alpha Variant VLP Vaccine

    Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus

  • SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variantBiological

    Also called Combination of Authentic and Alpha VLP Vaccine

    Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants

Study groups in NCT04962893
Study groupRoleWhat they receive
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.
Receives: Biological: SARS-CoV-2 VLP Vaccine-Wuhan
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.
Receives: Biological: SARS-CoV-2 VLP Vaccine-Alpha (British) variant
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.
Receives: Biological: SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of efficacy

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

    Measured: On Day 14 after booster dose administration

  2. Comparison of efficacy

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

    Measured: On Day 28 after booster dose administration

  3. Specific antibody (IgG) response

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

    Measured: On Day 14 after booster dose administration

  4. Specific antibody (IgG) response

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

    Measured: On Day 28 after booster dose administration

  5. Neutralizing antibody response

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

    Measured: On Day 14 after booster dose administration

  6. Neutralizing antibody response

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

    Measured: On Day 28 after booster dose administration

  7. Cellular immune response

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

    Measured: Before first dose administration, on Day 14 after booster dose administration

Secondary outcomes (3)

  1. Adverse events (AEs)

    Local and systemic AEs in all vaccine groups

    Measured: Until Month 12 after booster dose administration

  2. Serious adverse events (SAEs)

    SAEs in all vaccine groups

    Measured: Until Month 12 after booster dose administration

  3. Specific antibody (IgG) response

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

    Measured: Before first and booster dose administration, at Month 3, Month 6, Month 9 and Month 12 after booster dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start26 Jun 2021
  3. Primary completion16 Jan 2022
  4. Study completion16 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962893
Sponsor's protocol ID
VLP-58-1023-Al-K3-PII
Acronym
COVID-19
Status last verified
May 2022
First submitted
12 Jul 2021
Last updated
31 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Singh VA, Nehul S, Saha A, Singh V, Bhutkar M, Kumar CS, Banerjee M, Kuhn RJ, Kumar P, Sharma GK, Tomar S. Bioengineered chimeric VLPs targeting chikungunya virus and SARS-CoV-2 show high immunogenicity in mice. Biochem Biophys Res Commun. 2026 Mar 19;805:153346. doi: 10.1016/j.bbrc.2026.153346. Epub 2026 Jan 23.

    PubMed 41643552

  • 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.

    PubMed 39892108

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SARS-CoV-2 VLP Vaccine-Wuhan, SARS-CoV-2 VLP Vaccine-Alpha (British) variant and SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant in people with Covid19, run by Ihsan GURSEL, PhD, Prof. at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of efficacy (time frame: On Day 14 after booster dose administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04962893, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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