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Spikogen Booster Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05542862
Recruitment Status : Recruiting
First Posted : September 16, 2022
Last Update Posted : October 13, 2022
Sponsor:
Collaborators:
Australian Respiratory and Sleep Medicine Institute Ltd
Cinnagen
Information provided by (Responsible Party):
Vaxine Pty Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SpikoGen vaccine Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
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
Actual Study Start Date : September 7, 2022
Estimated Primary Completion Date : April 16, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SpikoGen vaccine
Single booster dose of SpikoGen Covid-19 vaccine
 Biological: SpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine
Other Name: Covax-19


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion [ Time Frame: Between baseline and 4 weeks post the booster dose ]
    Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group

  2. Seroprotection [ Time Frame: Between baseline and 4 weeks post the booster dose ]
    Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group

  3. Geometric mean titer fold change [ Time Frame: Between baseline and 4 weeks post the booster dose ]
    Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group

  4. Safety assessment 1 [ Time Frame: Occurring within 7 days after booster dose. ]
    Frequency of Adverse events by primary vaccine group

  5. Safety assessment 2 [ Time Frame: Between time of administration of booster dose and through study completion, an average of 3 months ]
    Frequency of Serious Adverse events by primary vaccine group

  6. SARS-CoV-2 infection [ Time Frame: Between time of administration of booster dose and through study completion, an average of 3 months ]
    Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection

  7. Antibody durability [ Time Frame: Between time of administration of booster dose and through study completion, an average of 3 months ]
    The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.

  8. Seroconversion in participants with and without evidence of past infection [ Time Frame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months ]
    Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group

  9. Seroprotection in participants with and without evidence of past infection [ Time Frame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months ]
    Spike antibody seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group

  10. Spike antibody GMT in participants with and without evidence of past infection [ Time Frame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months ]
    Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group.


Secondary Outcome Measures :
  1. Antibody correlates of protection [ Time Frame: Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months ]
    SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05542862


Contacts
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Contact: Sharen Pringle, GradCert 0437033400 office@arasmi.org

Locations
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Australia, South Australia
ARASMI Recruiting
Adelaide, South Australia, Australia, 5042
Contact: Sharen Pringle, GradCert    0437033400    office@arasmi.org   
Principal Investigator: Dimitar Sajkov, MBBS         
Sponsors and Collaborators
Vaxine Pty Ltd
Australian Respiratory and Sleep Medicine Institute Ltd
Cinnagen
Investigators
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Principal Investigator: Dimitar Sajkov, MD/PhD ARASMI
Study Director: Nikolai Petrovsky, MD/PhD Vaxine Pty Ltd
More Information
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Publications:

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Responsible Party: Vaxine Pty Ltd
ClinicalTrials.gov Identifier: NCT05542862    
Other Study ID Numbers: AUST-C19-booster
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaxine Pty Ltd:
covid-19
vaccine
adjuvant
 Spikogen
Advax
CpG55.2
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases