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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
38
VLP adjuvanted vaccine
0.9% NaCl
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center
Ankara, Turkey (Türkiye)
Acute adverse events (AEs)
Frequency of acute AEs in all dosage groups
Time frame: 24 hours
Solicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Time frame: 6 days
Unsolicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Time frame: 28 days
Specific antibody (IgG) response
IgG type antibody titers against anti-Spike protein of SARS-CoV-2 (by ELISA)
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
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
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)
ELISPOT: Interleukin-4 (IL4) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein
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)
ELISPOT: Interferon-γ (IFN-γ) positive cell level of peripheral blood mononuclear cells (PBMCs) stimulated with rec. S protein
Time frame: Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.