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A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)

NCT05279456 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-09-17

No results posted yet for this study

Summary

This study will determine the immunogenicity of Spikogen in vaccine naïve individuals. Spikogen will be administered as two doses 1 month apart with a third booster dose either 1 or 3 months after the second dose. This study will provide key data on SARS-CoV-2 antibody responses.

Conditions

Interventions

BIOLOGICAL

Advax-CpG55.2 adjuvanted recombinant spike protein

recombinant SARS-CoV-2 spike protein formulated with Advax-CpG55.2 adjuvant

Sponsors & Collaborators

  • Australian Respiratory and Sleep Medicine Institute

    collaborator OTHER

  • Vaxine Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Dimitar Sajkov, MBBS · ARASMI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05279456 on ClinicalTrials.gov