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

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).

Timeline

Start

2021-03-27

Primary completion

2021-12-29

Completion

2021-12-29

Publications

• Yilmaz IC, Ipekoglu EM, Golcuklu BS, Bildik T, Aksoy AGB, Evcili I, Turay N, Surucu N, Bulbul A, Guvencli N, Yildirim M, Canavar Yildirim T, Atalay YA, Abras I, Ceylan Y, Ozsurekci Y, Tigen ET, Korten V, Gursel M, Gursel I. A phase I/II study of CpG/alum-adjuvanted mammalian-derived quadruple antigen carrying virus-like particle COVID-19 vaccine. Vaccine. 2025 Mar 7;49:126787. doi: 10.1016/j.vaccine.2025.126787. Epub 2025 Jan 31.

Drugs

Indications