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

NCT04818281 | Completed Phase 1 DMC

• 1 other identifier: VLP-58-1023-Al-K3
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Covid19

Keywords

Virus-like Particles harboring S, M, N, E antigens; SARS-CoV-2; K3-CpG ODN; Alum

Outcome Measures

Primary Outcomes (3)

• Acute adverse events (AEs)

  Frequency of acute AEs in all dosage groups

  24 hours

• Solicited local and systemic adverse events (AEs)

  Frequency of local and systemic AEs in all dosage groups

  6 days

• Unsolicited local and systemic adverse events (AEs)

  Frequency of local and systemic AEs in all dosage groups

  28 days

Secondary Outcomes (4)

• Specific antibody (IgG) response

  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

  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)

  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)

  Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose

Study Arms (3)

Low-Dose Group (Group A)

EXPERIMENTAL

12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)

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)

Biological: SARS-CoV-2 VLP Vaccine

Placebo Group

PLACEBO COMPARATOR

12 participants will receive 1 ml of 0.9% sodium chloride (NaCl)

Biological: Placebo

Interventions

SARS-CoV-2 VLP Vaccine BIOLOGICAL

VLP adjuvanted vaccine

High-Dose Group (Group B); Low-Dose Group (Group A)

Placebo BIOLOGICAL

0.9% NaCl

Placebo Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ihsan GURSEL, PhD, Prof.: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• MonitorCRO: collaborator
• Nobel Pharmaceuticals: collaborator
• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: collaborator

Study Sites (1)

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

Ankara, 06200, Turkey (Türkiye)

Location

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: 39892108 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: PhD, Prof

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: March 27, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

TU (1)