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

NCT04818281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-05-25

No results posted yet for this study

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).

Conditions

  • Covid19

Interventions

BIOLOGICAL

SARS-CoV-2 VLP Vaccine

VLP adjuvanted vaccine

BIOLOGICAL

Placebo

0.9% NaCl

Sponsors & Collaborators

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    collaborator OTHER

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • MonitorCRO

    collaborator INDUSTRY

  • Nobel Pharmaceuticals

    collaborator INDUSTRY

  • Ihsan GURSEL, PhD, Prof.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-27
Primary Completion
2021-12-29
Completion
2021-12-29

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818281 on ClinicalTrials.gov