NCT05279456

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Aug 2022

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

March 7, 2022

Last Update Submit

September 16, 2025

Conditions

COVID-19

Keywords

sars-cov-2coronavirusvaccineadjuvantAdvaxSpikogenCovax-19

Outcome Measures

Primary Outcomes (12)

  • First dose Seroconversion

    Proportion of subjects in each group stratified by baseline antibody positivity seroconverting to spike protein antibody positivity

    2-4 weeks post first immunisation

  • Second dose Seroconversion

    Proportion of subjects in each group stratified by baseline antibody positivity seroconverting to spike protein antibody positivity

    2-4 weeks post second immunisation

  • Third Dose Seroconversion

    Proportion of subjects in each group stratified by baseline antibody positivity seroconverting to spike protein antibody positivity

    2-4 weeks post third immunisation

  • Final Seroconversion

    Proportion of subjects in each group stratified by baseline antibody positivity seroconverting to spike protein antibody positivity

    through study completion, an average of 7 months

  • First Dose GMT

    Spike protein antibody Geometric Mean Titers (GMT) in each group stratified by baseline antibody positivity

    2-4 weeks post first immunisation

  • Second Dose GMT

    Spike protein antibody Geometric Mean Titers (GMT) in each group stratified by baseline antibody positivity

    2-4 weeks post second immunisation

  • Third Dose GMT

    Spike protein antibody Geometric Mean Titers (GMT)in each group stratified by baseline antibody positivity

    2-4 weeks post third immunisation

  • Final GMT

    Spike protein antibody Geometric Mean Titers (GMT)in each group stratified by baseline antibody positivity

    through study completion, an average of 7 months

  • First Dose Adverse events (AE)

    AE occurring within 7 days of immunisation in each group stratified by baseline antibody positivity

    7 days post first immunisation

  • Second Dose Adverse events (AE)

    AE occurring within 7 days of immunisation in each group stratified by baseline antibody positivity

    7 days post second immunisation

  • Third Dose Adverse events (AE)

    AE occurring within 7 days of immunisation in each group stratified by baseline antibody positivity

    7 days post third immunisation

  • Serious adverse events (SAE)

    Number of Serious adverse events (SAE) occurring within study period in each group stratified by baseline antibody positivity

    through study completion, an average of 7 months

Secondary Outcomes (6)

  • First dose Vaccine efficacy

    From 2 weeks post-first dose to 2 weeks after second dose

  • Second dose Vaccine efficacy

    From 2 weeks post-second dose to 2 weeks after third dose

  • Third dose Vaccine efficacy

    From 2 weeks post-third dose through study completion, an average of 7 months

  • Total Covid-19 infections

    From first vaccine dose through study completion, an average of 7 months

  • Seroconversion against variants of concern

    2-4 weeks post first, second and third immunisation and at study completion

  • +1 more secondary outcomes

Other Outcomes (5)

  • Antibody kinetics

    2-4 weeks post first, second and third immunisation and at study completion

  • Age effects on seroconversion

    2-4 weeks post first, second and third immunisation and at study completion

  • Age effects on antibody levels

    2-4 weeks post first, second and third immunisation and at study completion

  • +2 more other outcomes

Study Arms (2)

Spikogen vaccine - accelerated arm

EXPERIMENTAL

Spikogen vaccine 25 micrograms by intramuscular injection on study months 0, 1 and 2

Biological: Advax-CpG55.2 adjuvanted recombinant spike protein

Spikogen vaccine - standard arm

EXPERIMENTAL

Spikogen vaccine 25 micrograms by intramuscular injection on study months 0, 1 and 4

Biological: Advax-CpG55.2 adjuvanted recombinant spike protein

Interventions

Advax-CpG55.2 adjuvanted recombinant spike proteinBIOLOGICAL

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

Also known as: Spikogen vaccine
Spikogen vaccine - accelerated armSpikogen vaccine - standard arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written informed consent
  • Males or females\* 18 years of age or older
  • Understand and are likely to comply with planned study procedures and be available for all study visits.
  • Have not previously had a Covid-19 vaccine and do not intend to have a non-study Covid-19 vaccine within the next 6 months

You may not qualify if:

  • History of Covid-19 vaccination.
  • History of serious vaccine allergy.
  • Pregnancy1
  • Have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial reporting period.
  • Any medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ARASMI

Adelaide, South Australia, 5042, Australia

Location

Related Publications (1)

  • Li L, Honda-Okubo Y, Huang Y, Jang H, Carlock MA, Baldwin J, Piplani S, Bebin-Blackwell AG, Forgacs D, Sakamoto K, Stella A, Turville S, Chataway T, Colella A, Triccas J, Ross TM, Petrovsky N. Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection. Vaccine. 2021 Sep 24;39(40):5940-5953. doi: 10.1016/j.vaccine.2021.07.087. Epub 2021 Aug 3.

    PMID: 34420786BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dimitar Sajkov, MBBS

    ARASMI

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Subjects will be stratified for analysis by age, sex and seropositivity at time of study entry
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 15, 2022

Study Start

August 15, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is no current plan to share IPD with other researchers, but requests for data access will be considered on a case by case basis

Locations

AU(1)