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

Covid19 Clinical Trial

— COVID-19  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818281
• Other study ID #: VLP-58-1023-Al-K3
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2021
• Est. completion date: December 29, 2021

Study information

• Verified date: May 2022
• Source: The Scientific and Technological Research Council of Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• SARS-CoV-2 VLP Vaccine
VLP adjuvanted vaccine
• Placebo
0.9% NaCl

Locations

Country	Name	City	State
Turkey	Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center	Ankara

Sponsors (5)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute adverse events (AEs)	Frequency of acute AEs in all dosage groups	24 hours
Primary	Solicited local and systemic adverse events (AEs)	Frequency of local and systemic AEs in all dosage groups	6 days
Primary	Unsolicited local and systemic adverse events (AEs)	Frequency of local and systemic AEs in all dosage groups	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Cellular immune response (IFN-?)	ELISPOT: Interferon-? (IFN-?) 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