This is a randomized, parallel dose assigned, double blind, multi center, Phase II study assessing the efficacy, safety, and immunogenicity of VLP vaccine (Authentic and Alpha variants) in adults between 18 and 59 years who are healthy or have medically stable chronic diseases and who have no known history of SARS-CoV-2 infection
The primary objective of the study is to evaluate the humoral and cellular immune response of VLP vaccine candidates (harboring M, N, E, and HexaPro S antigens of the virus), as an efficacy criteria. Approximately 330 subjects will be randomized in a 1:1:1 ratio to receive two doses of 40 mcg VLP vaccine for Wuhan (n=110) or 40 mcg VLP vaccine for Alpha (British) variant (n=110) or 40 mcg VLP vaccine for Wuhan+Alpha variant (n=110) 21 days apart. The study will be completed in 14 months. All injections will be done subcutaneously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
349
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center
Ankara, Turkey (Türkiye)
Health Sciences University İstanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
Kocaeli University Research and Application Hospital Infectious Disease and Clinical Microbiology Department
Kocaeli, Turkey (Türkiye)
Comparison of efficacy
Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).
Time frame: On Day 14 after booster dose administration
Comparison of efficacy
Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).
Time frame: On Day 28 after booster dose administration
Specific antibody (IgG) response
SARS-CoV-2 Spike/S1 or RBD antibody titers
Time frame: On Day 14 after booster dose administration
Specific antibody (IgG) response
SARS-CoV-2 Spike/S1 or RBD antibody titers
Time frame: On Day 28 after booster dose administration
Neutralizing antibody response
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
Time frame: On Day 14 after booster dose administration
Neutralizing antibody response
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
Time frame: On Day 28 after booster dose administration
Cellular immune response
ELISPOT: Interferon-γ (IFN-γ) positive level of T-cells
Time frame: Before first dose administration, on Day 14 after booster dose administration
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Adverse events (AEs)
Local and systemic AEs in all vaccine groups
Time frame: Until Month 12 after booster dose administration
Serious adverse events (SAEs)
SAEs in all vaccine groups
Time frame: Until Month 12 after booster dose administration
Specific antibody (IgG) response
SARS-CoV-2 Spike/S1 or RBD antibody titers
Time frame: Before first and booster dose administration, at Month 3, Month 6, Month 9 and Month 12 after booster dose