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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06355232
Registration number
NCT06355232
Ethics application status
Date submitted
7/04/2024
Date registered
9/04/2024
Date last updated
9/04/2024
Titles & IDs
Public title
Covid-19 and Influenza Oral Vaccine Study
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Scientific title
A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
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Secondary ID [1]
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Vaxine-2301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
covid19 Infection
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Influenza, Human
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Covid-19 vaccine
Other interventions - Influenza vaccine
Experimental: Covid-19 vaccine group - Subjects in this group will receive two sublingual doses of COVID-19 vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of influenza vaccine two weeks apart.
Experimental: Influenza vaccine group - Subjects in this group will receive two sublingual doses of influenza vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of COVID-19 vaccine two weeks apart.
Experimental: Combined vaccine group - Subjects in this group will receive two sublingual doses of combined COVID-19 and influenza vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of placebo vaccine two weeks apart.
Other interventions: Covid-19 vaccine
Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant
Other interventions: Influenza vaccine
Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SARS-CoV-2 Seroconversion
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Assessment method [1]
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Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
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Timepoint [1]
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Between baseline and 2 weeks post the second dose
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Primary outcome [2]
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Influenza Seroconversion
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Assessment method [2]
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Proportion of study participants who seroconvert (4-fold or greater rise in hemagglutinin antibody) by primary vaccine group
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Timepoint [2]
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Between baseline and 2 weeks post the second dose
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Primary outcome [3]
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SARS-CoV-2 Seroprotection
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Assessment method [3]
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Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
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Timepoint [3]
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Between baseline and 2 weeks post the second dose
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Primary outcome [4]
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Influenza Seroprotection
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Assessment method [4]
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Proportion of study participants who achieve a hemagglutinin neutralisation titer of 40 or greater by primary vaccine group
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Timepoint [4]
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Between baseline and 2 weeks post the second dose
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Primary outcome [5]
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SARS-CoV-2 Geometric mean titer fold change
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Assessment method [5]
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Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
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Timepoint [5]
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Between baseline and 2 weeks post the second dose
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Primary outcome [6]
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Influenza geometric mean titer fold change
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Assessment method [6]
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Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
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Timepoint [6]
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Between baseline and 2 weeks post the second dose
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Primary outcome [7]
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Safety assessment 1
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Assessment method [7]
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Frequency of Adverse events by primary vaccine group
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Timepoint [7]
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Between time of administration of first dose and through study completion, an average of 10 months
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Primary outcome [8]
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Safety assessment 2
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Assessment method [8]
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Frequency of Serious Adverse events by primary vaccine group
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Timepoint [8]
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Between time of administration of first dose and through study completion, an average of 10 months
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Primary outcome [9]
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SARS-CoV-2 infection
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Assessment method [9]
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Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
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Timepoint [9]
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From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
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Primary outcome [10]
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Influenza infection
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Assessment method [10]
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Frequency ofinfluenza infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
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Timepoint [10]
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From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
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Secondary outcome [1]
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Antibody durability
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Assessment method [1]
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The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
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Timepoint [1]
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From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
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Secondary outcome [2]
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Seroconversion in participants with and without evidence of past infection
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Assessment method [2]
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Antibody seroconversion in participants by primary vaccine group
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Timepoint [2]
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From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
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Secondary outcome [3]
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Antibody GMT in participants with and without evidence of past infection
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Assessment method [3]
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Antibody GMT in baseline seropositive versus negative participants by primary vaccine group.
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Timepoint [3]
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From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
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Secondary outcome [4]
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Antibody correlates of protection
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Assessment method [4]
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antibody levels in subjects with or without breakthrough infection
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Timepoint [4]
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From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
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Eligibility
Key inclusion criteria
- 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.
- Do not plan to have a non-study COVID-19 or influenza vaccine within the next 6
months.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Allergy to COVID-19 or seasonal influenza vaccine or one of its components e.g.
polysorbate 80.
- Have received a COVID-19 or influenza vaccine or an experimental agent within 30 days
prior to the study vaccination or expect to receive another experimental agent or a
COVID-19 or influenza vaccine 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
21/04/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
21/04/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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ARASMI - Adelaide
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Recruitment postcode(s) [1]
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5042 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vaxine Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian Respiratory and Sleep Medicine Institute Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or
influenza vaccines when given individually or together via oral/ sublingual mucosal route
instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which
will also be administered with Advax-CpG adjuvant via the oral route. This study will use a
cross-over design and everyone in the study will over a space of about 4 months receive both
the COVID-19 and influenza vaccines.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06355232
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dimitar Sajkov, MBBS/PhD
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Address
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ARASMI
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sharen Pringle, GradCert
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Address
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Country
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Phone
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0437033400
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06355232
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