Spikogen Booster Study

Sponsor
Vaxine Pty Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05542862
Collaborator
Australian Respiratory and Sleep Medicine Institute Ltd (Other), Cinnagen (Industry)
150
1
1
9.4
15.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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 receivedAll 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
Anticipated Study Start Date :
Sep 16, 2022
Anticipated Primary Completion Date :
Apr 16, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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 Names:
  • Covax-19
  • Outcome Measures

    Primary Outcome Measures

    1. Seroconversion [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 [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 [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 [Occurring within 7 days after booster dose.]

      Frequency of Adverse events by primary vaccine group

    5. Safety assessment 2 [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 [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 [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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 ARASMI Adelaide South Australia Australia 5042

    Sponsors and Collaborators

    • Vaxine Pty Ltd
    • Australian Respiratory and Sleep Medicine Institute Ltd
    • Cinnagen

    Investigators

    • Principal Investigator: Dimitar Sajkov, MD/PhD, ARASMI
    • Study Director: Nikolai Petrovsky, MD/PhD, Vaxine Pty Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Vaxine Pty Ltd
    ClinicalTrials.gov Identifier:
    NCT05542862
    Other Study ID Numbers:
    • AUST-C19-booster
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vaxine Pty Ltd
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2022