Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults (COVID-19)
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ClinicalTrials.gov Identifier: NCT04818281 |
Recruitment Status :
Completed
First Posted : March 26, 2021
Last Update Posted : May 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Covid19 | Biological: SARS-CoV-2 VLP Vaccine Biological: Placebo | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double-blinded |
Primary Purpose: | Prevention |
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. |
Actual Study Start Date : | March 27, 2021 |
Actual Primary Completion Date : | December 29, 2021 |
Actual Study Completion Date : | December 29, 2021 |

Arm | Intervention/treatment |
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Experimental: Low-Dose Group (Group A)
12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
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Biological: SARS-CoV-2 VLP Vaccine
VLP adjuvanted vaccine |
Experimental: High-Dose Group (Group B)
12 participants will receive 40 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
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Biological: SARS-CoV-2 VLP Vaccine
VLP adjuvanted vaccine |
Placebo Comparator: Placebo Group
12 participants will receive 1 ml of 0.9% sodium chloride (NaCl)
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Biological: Placebo
0.9% NaCl |
- 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
- 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 ]IgG type antibody titers against anti-Spike protein of SARS-CoV-2 (by ELISA)
- 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 ]Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
- 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 ]ELISPOT: Interleukin-4 (IL4) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein
- 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 ]ELISPOT: Interferon-γ (IFN-γ) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein

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.
Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
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:
- 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,
- 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,
Exclusion Criteria:
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,
- 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.

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): NCT04818281
Turkey | |
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center | |
Ankara, Turkey, 06200 |
Responsible Party: | Ihsan GURSEL, PhD, Prof., PhD, Prof, The Scientific and Technological Research Council of Turkey |
ClinicalTrials.gov Identifier: | NCT04818281 |
Other Study ID Numbers: |
VLP-58-1023-Al-K3 |
First Posted: | March 26, 2021 Key Record Dates |
Last Update Posted: | May 25, 2022 |
Last Verified: | May 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Virus-like Particles harboring S, M, N, E antigens SARS-CoV-2 K3-CpG ODN Alum |
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 |