This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine 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 20 participants and placebo administration to 5 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and will continue accordingly. In the study, 50 healthy participants of 18-45 years of age will be recruited. All injections will be done subcutaneously. Injections will be administered at 1 and 21 days. The participants will be followed for 6 months and the study will be completed in 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
50
Adjuvanted inactivated vaccine
0.9% NaCl
Ankara City Hospital Phase I Drug Research Center
Ankara, Turkey (Türkiye)
Acute adverse events (AEs)
Frequency of acute adverse events 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: 15 days
Unsolicited local and systemic adverse events (AEs)
Frequency of local and systemic AEs in all dosage groups
Time frame: 28 days
Neutralizing antibody response
Immunogenicity response by measuring neutralizing antibody titer (anti-spike and anti-RBD) developed against SARS-CoV-2 (by ELISA)
Time frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
Cellular immune response
Interferon-γ (IFN-γ) positive cell level (by ELISPOT)
Time frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
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