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

Summary

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

Timeline

Start

2021-06-26

Primary completion

2022-01-16

Completion

2022-01-16

Publications

• Singh VA, Nehul S, Saha A, Singh V, Bhutkar M, Kumar CS, Banerjee M, Kuhn RJ, Kumar P, Sharma GK, Tomar S. Bioengineered chimeric VLPs targeting chikungunya virus and SARS-CoV-2 show high immunogenicity in mice. Biochem Biophys Res Commun. 2026 Mar 19;805:153346. doi: 10.1016/j.bbrc.2026.153346. Epub 2026 Jan 23.
• 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