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

NCT04962893 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2022-05-31

No results posted yet for this study

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

Conditions

  • Covid19

Interventions

BIOLOGICAL

SARS-CoV-2 VLP Vaccine-Wuhan

Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus

BIOLOGICAL

SARS-CoV-2 VLP Vaccine-Alpha (British) variant

Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus

BIOLOGICAL

SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant

Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • Nobel Pharmaceuticals

    collaborator INDUSTRY

  • MonitorCRO

    collaborator INDUSTRY

  • Ihsan GURSEL, PhD, Prof.

    lead OTHER

Principal Investigators

  • Fevzi ALTUNTAS · HEAD OF ONCOLOGY HOSPITAL

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
2021-06-26
Primary Completion
2022-01-16
Completion
2022-01-16

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT04962893 on ClinicalTrials.gov