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Spikogen Booster Study

Primary Purpose

COVID-19

Status
Active
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
SpikoGen vaccine
Sponsored by
Vaxine Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring covid-19, vaccine, adjuvant, Spikogen, Advax, CpG55.2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to provide written informed consent
  • Males or females 18 years of age or older
  • Have previously had a primary course of Covid-19 vaccine with the most recent dose no less than 3 months previously.
  • Understand and are likely to comply with planned study procedures and be available for all study visits.

Exclusion Criteria

  • Allergy to Spikogen vaccine or one of its components, e.g. polysorbate 80.
  • 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 serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Sites / Locations

  • ARASMI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SpikoGen vaccine

Arm Description

Single booster dose of SpikoGen Covid-19 vaccine

Outcomes

Primary Outcome Measures

Seroconversion
Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
Seroprotection
Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Geometric mean titer fold change
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Safety assessment 1
Frequency of Adverse events by primary vaccine group
Safety assessment 2
Frequency of Serious Adverse events by primary vaccine group
SARS-CoV-2 infection
Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
Antibody durability
The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
Seroconversion in participants with and without evidence of past infection
Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Seroprotection in participants with and without evidence of past infection
Spike antibody seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Spike antibody GMT in participants with and without evidence of past infection
Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group.

Secondary Outcome Measures

Antibody correlates of protection
SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection

Full Information

First Posted
September 8, 2022
Last Updated
August 3, 2023
Sponsor
Vaxine Pty Ltd
Collaborators
Australian Respiratory and Sleep Medicine Institute Ltd, Cinnagen
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1. Study Identification

Unique Protocol Identification Number
NCT05542862
Brief Title
Spikogen Booster Study
Official Title
Immunogenicity and Safety Study in Ambulatory Adults of a Single Intramuscular Dose of SpikoGen Vaccine as a Heterologous or Homologous Booster Dose Following Completion of a Primary Course of Covid-19 Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaxine Pty Ltd
Collaborators
Australian Respiratory and Sleep Medicine Institute Ltd, Cinnagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to assess the effectiveness of Spikogen vaccine when used as a 3rd or 4th dose booster in adults who have been previously vaccinated with any Covid-19 vaccine types, including mRNA vaccine, adenoviral vector vaccines, recombinant protein vaccines, or inactivated virus vaccines.
Detailed Description
Currently in Australia, mRNA, adenoviral vector and recombinant protein vaccines have provisional approval for use as 3rd or 4th booster doses. This study will provide important data on the use of Spikogen as an alternative recombinant protein booster vaccine. The study will provide data in ambulatory adults on the safety and effectiveness of Spikogen vaccine when administered as a single intramuscular booster dose in those who previously vaccinated with mRNA vaccine in comparison to those immunised with other Covid-19 vaccine platforms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
covid-19, vaccine, adjuvant, Spikogen, Advax, CpG55.2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive the same single intervention with analysis groups being based on the type of primary vaccine received
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SpikoGen vaccine
Arm Type
Experimental
Arm Description
Single booster dose of SpikoGen Covid-19 vaccine
Intervention Type
Biological
Intervention Name(s)
SpikoGen vaccine
Other Intervention Name(s)
Covax-19
Intervention Description
Recombinant spike protein based Covid-19 vaccine
Primary Outcome Measure Information:
Title
Seroconversion
Description
Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
Time Frame
Between baseline and 4 weeks post the booster dose
Title
Seroprotection
Description
Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Time Frame
Between baseline and 4 weeks post the booster dose
Title
Geometric mean titer fold change
Description
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Time Frame
Between baseline and 4 weeks post the booster dose
Title
Safety assessment 1
Description
Frequency of Adverse events by primary vaccine group
Time Frame
Occurring within 7 days after booster dose.
Title
Safety assessment 2
Description
Frequency of Serious Adverse events by primary vaccine group
Time Frame
Between time of administration of booster dose and through study completion, an average of 3 months
Title
SARS-CoV-2 infection
Description
Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
Time Frame
Between time of administration of booster dose and through study completion, an average of 3 months
Title
Antibody durability
Description
The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
Time Frame
Between time of administration of booster dose and through study completion, an average of 3 months
Title
Seroconversion in participants with and without evidence of past infection
Description
Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Time Frame
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Title
Seroprotection in participants with and without evidence of past infection
Description
Spike antibody seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Time Frame
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Title
Spike antibody GMT in participants with and without evidence of past infection
Description
Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group.
Time Frame
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Antibody correlates of protection
Description
SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection
Time Frame
Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent Males or females 18 years of age or older Have previously had a primary course of Covid-19 vaccine with the most recent dose no less than 3 months previously. Understand and are likely to comply with planned study procedures and be available for all study visits. Exclusion Criteria Allergy to Spikogen vaccine or one of its components, e.g. polysorbate 80. 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 serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitar Sajkov, MD/PhD
Organizational Affiliation
ARASMI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikolai Petrovsky, MD/PhD
Organizational Affiliation
Vaxine Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
ARASMI
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35436611
Citation
Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Roshanzamir K, Bayatani B, Taheri A, Petrovsky N, Li L, Barati S. Safety and immunogenicity of SpikoGen(R), an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations. Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
Results Reference
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PubMed Identifier
35758850
Citation
Tabarsi P, Anjidani N, Shahpari R, Roshanzamir K, Fallah N, Andre G, Petrovsky N, Barati S. Immunogenicity and safety of SpikoGen(R), an adjuvanted recombinant SARS-CoV-2 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo-controlled trial. Immunology. 2022 Nov;167(3):340-353. doi: 10.1111/imm.13540. Epub 2022 Jul 13.
Results Reference
background
PubMed Identifier
35465982
Citation
Li L, Honda-Okubo Y, Baldwin J, Bowen R, Bielefeldt-Ohmann H, Petrovsky N. Covax-19/Spikogen(R) vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters. Vaccine. 2022 May 20;40(23):3182-3192. doi: 10.1016/j.vaccine.2022.04.041. Epub 2022 Apr 18.
Results Reference
background
PubMed Identifier
34420786
Citation
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.
Results Reference
background
PubMed Identifier
36096430
Citation
Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Kafi H, Fallah N, Ebrahimi A, Taheri A, Petrovsky N, Barati S. Evaluating the efficacy and safety of SpikoGen(R), an Advax-CpG55.2-adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial. Clin Microbiol Infect. 2023 Feb;29(2):215-220. doi: 10.1016/j.cmi.2022.09.001. Epub 2022 Sep 10.
Results Reference
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Spikogen Booster Study

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