Covid19Phase 1COVID-19NCT04818281
Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults
A Phase 1 study testing SARS-CoV-2 VLP Vaccine in people with Covid19, run by Ihsan GURSEL, PhD, Prof. at 1 site in Turkey (Türkiye).
Trial 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. 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2021to 29 Dec 2021
- Phase
- Phase 1
- 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:
- Healthy participants between 18-59 years of age,
- Sign an informed consent document,
- Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- Able to comply with the study protocol during the study period,
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- Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
- Body temperature <37.2 C,
- Body mass index 18-35 kg/m2,
- Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose,
- Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
- 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,
- Male participants who will be able to have appropriate contraception methods for 6 months after vaccination,
Who cannot join
- Participants with any of the following criteria will be excluded:
- History of seizure, encephalopathy or psychosis,
- History of allergic reactions to any known vaccine or to any component of the study vaccine,
- Pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months,
- Active infection signs or body temperature >37.2 C,
- History of SARS-CoV-2 infection,
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- Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
- Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
- Congenital or acquired angioedema,
- Diagnosis of immunodeficiency,
- Diagnosis of bleeding diathesis,
- Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
- Those who received blood and blood product transfusions in the last 6 months,
- Those on any vaccine program or experimental medication within 1 month prior to the study,
- History of any live vaccine administration within 1 month prior to the study,
- History of any inactive vaccine administration within 1 month prior to the study,
- Use of active tuberculosis treatment,
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center
Ankara, 06200
About this study
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.
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).
Read the 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 (harboring M, N, E, and hexapro modified S proteins of SARS-CoV-2 virus) 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.
- Conditions
- Covid19
- Being tested
- SARS-CoV-2 VLP Vaccine, Placebo
- 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 VaccineBiological
VLP adjuvanted vaccine
PlaceboBiological
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Group (Group A) | Experimental | 12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3) Receives: Biological: SARS-CoV-2 VLP Vaccine |
| High-Dose Group (Group B) | Experimental | 12 participants will receive 40 µg VLP vaccine (adjuvanted with alum and CpGODN-K3) Receives: Biological: SARS-CoV-2 VLP Vaccine |
| Placebo Group | Placebo comparator | 12 participants will receive 1 ml of 0.9% sodium chloride (NaCl) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute adverse events (AEs)
Frequency of acute AEs in all dosage groups
Measured: 24 hours
Solicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Measured: 6 days
Unsolicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Measured: 28 days
Secondary outcomes (4)
Specific antibody (IgG) response
IgG type antibody titers against anti-Spike protein of SARS-CoV-2 (by ELISA)
Measured: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose
Neutralizing antibody response
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
Measured: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose
Cellular immune response (IL-4)
ELISPOT: Interleukin-4 (IL4) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein
Measured: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose
Cellular immune response (IFN-γ)
ELISPOT: Interferon-γ (IFN-γ) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein
Measured: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start27 Mar 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ihsan GURSEL, PhD, Prof.
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, The Scientific and Technological Research Council of Turkey, MonitorCRO, Nobel Pharmaceuticals
- Responsible party
- Sponsor-investigator, Ihsan GURSEL, PhD, Prof., The Scientific and Technological Research Council of Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818281
- Sponsor's protocol ID
- VLP-58-1023-Al-K3
- Acronym
- COVID-19
- Status last verified
- May 2022
- First submitted
- 24 Mar 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04818281
- Acronym / sponsor ID
- COVID-19 / VLP-58-1023-Al-K3
- Conditions
- Covid19
- Keywords
- Virus-like Particles harboring S, M, N, E antigens, SARS-CoV-2, K3-CpG ODN, Alum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ihsan GURSEL, PhD, Prof.University, hospital or other
- Collaborators
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, The Scientific and Technological Research Council of Turkey, MonitorCRO, Nobel Pharmaceuticals
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 (harboring M, N, E, and hexapro modified S proteins of SARS-CoV-2 virus) 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Group (Group A) | Experimental | Biological: SARS-CoV-2 VLP Vaccine12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3) |
| High-Dose Group (Group B) | Experimental | Biological: SARS-CoV-2 VLP Vaccine12 participants will receive 40 µg VLP vaccine (adjuvanted with alum and CpGODN-K3) |
| Placebo Group | Placebo comparator | Biological: Placebo12 participants will receive 1 ml of 0.9% sodium chloride (NaCl) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy participants between 18-59 years of age,
- Sign an informed consent document,
- Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- Able to comply with the study protocol during the study period,
Key exclusion criteria (18 listed)
- History of seizure, encephalopathy or psychosis,
- History of allergic reactions to any known vaccine or to any component of the study vaccine,
- Pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months,
- Active infection signs or body temperature >37.2 C,
- History of SARS-CoV-2 infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 VLP VaccineVLP adjuvanted vaccine | Biological | High-Dose Group (Group B), Low-Dose Group (Group A) |
| Placebo0.9% NaCl | Biological | Placebo Group |
Primary outcome
Acute adverse events (AEs)
Time frame: 24 hours
Frequency of acute AEs in all dosage groups
Solicited local and systemic adverse events (AEs)
Time frame: 6 days
Frequency of local and systemic AEs in all dosage groups
Unsolicited local and systemic adverse events (AEs)
Time frame: 28 days
Frequency of local and systemic AEs in all dosage groups
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 39892108Yilmaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SARS-CoV-2 VLP Vaccine in people with Covid19, run by Ihsan GURSEL, PhD, Prof. at 1 site 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 13 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 25 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 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Acute adverse events (AEs) (time frame: 24 hours). The study lists 3 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 NCT04818281, which also lists 1 linked publication.
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 25 May 2022.