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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
Scientific title
A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
Secondary ID [1] 0 0
Vaxine-2301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
covid19 Infection 0 0
Influenza, Human 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SARS-CoV-2 Seroconversion
Timepoint [1] 0 0
Between baseline and 2 weeks post the second dose
Primary outcome [2] 0 0
Influenza Seroconversion
Timepoint [2] 0 0
Between baseline and 2 weeks post the second dose
Primary outcome [3] 0 0
SARS-CoV-2 Seroprotection
Timepoint [3] 0 0
Between baseline and 2 weeks post the second dose
Primary outcome [4] 0 0
Influenza Seroprotection
Timepoint [4] 0 0
Between baseline and 2 weeks post the second dose
Primary outcome [5] 0 0
SARS-CoV-2 Geometric mean titer fold change
Timepoint [5] 0 0
Between baseline and 2 weeks post the second dose
Primary outcome [6] 0 0
Influenza geometric mean titer fold change
Timepoint [6] 0 0
Between baseline and 2 weeks post the second dose
Primary outcome [7] 0 0
Safety assessment 1
Timepoint [7] 0 0
Between time of administration of first dose and through study completion, an average of 10 months
Primary outcome [8] 0 0
Safety assessment 2
Timepoint [8] 0 0
Between time of administration of first dose and through study completion, an average of 10 months
Primary outcome [9] 0 0
SARS-CoV-2 infection
Timepoint [9] 0 0
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Primary outcome [10] 0 0
Influenza infection
Timepoint [10] 0 0
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Secondary outcome [1] 0 0
Antibody durability
Timepoint [1] 0 0
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Secondary outcome [2] 0 0
Seroconversion in participants with and without evidence of past infection
Timepoint [2] 0 0
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Secondary outcome [3] 0 0
Antibody GMT in participants with and without evidence of past infection
Timepoint [3] 0 0
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Secondary outcome [4] 0 0
Antibody correlates of protection
Timepoint [4] 0 0
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
21/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/04/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
ARASMI - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Respiratory and Sleep Medicine Institute Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06355232
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dimitar Sajkov, MBBS/PhD
Address 0 0
ARASMI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharen Pringle, GradCert
Address 0 0
Country 0 0
Phone 0 0
0437033400
Fax 0 0
Email 0 0
office@arasmi.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06355232