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

  • STATUS
    Recruiting
  • End date
    Sep 24, 2022
  • participants needed
    330
  • sponsor
    Ihsan GURSEL, PhD, Prof.
Updated on 24 July 2021

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

Description

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.

Details
Condition COVID19
Treatment SARS-CoV-2 VLP Vaccine-Wuhan, SARS-CoV-2 VLP Vaccine-Alpha (British) variant, SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant
Clinical Study IdentifierNCT04962893
SponsorIhsan GURSEL, PhD, Prof.
Last Modified on24 July 2021

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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