Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults (COVID-19)

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).

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Biological: Placebo; Biological: SARS-CoV-2 VLP Vaccine

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06200
    • Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be eligible for the study, each participant must satisfy all the following criteria:

1. Healthy participants between 18-59 years of age,
2. Sign an informed consent document,
3. Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
4. Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
5. Able to comply with the study protocol during the study period,
6. Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
7. Body temperature <37.2 C,
8. Body mass index 18-35 kg/m2,
9. Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose,
10. Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
11. 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,
12. 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:

1. History of seizure, encephalopathy or psychosis,
2. History of allergic reactions to any known vaccine or to any component of the study vaccine,
3. Pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months,
4. Active infection signs or body temperature >37.2 C,
5. History of SARS-CoV-2 infection,
6. Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
7. Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
8. Congenital or acquired angioedema,
9. Diagnosis of immunodeficiency,
10. Diagnosis of bleeding diathesis,
11. Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
12. Those who received blood and blood product transfusions in the last 6 months,
13. Those on any vaccine program or experimental medication within 1 month prior to the study,
14. History of any live vaccine administration within 1 month prior to the study,
15. History of any inactive vaccine administration within 1 month prior to the study,
16. Use of active tuberculosis treatment,
17. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low-Dose Group (Group A); 12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)	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)	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)	Biological: Placebo; 0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific antibody (IgG) response	IgG type antibody titers against anti-Spike protein of SARS-CoV-2 (by ELISA)	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	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	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	Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2021
• Primary Completion (ACTUAL): December 29, 2021
• Study Completion (ACTUAL): December 29, 2021

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Alum; Virus-like Particles harboring S, M, N, E antigens; K3-CpG ODN
• Other Study ID Numbers: VLP-58-1023-Al-K3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No