covid19 InfectionPhase 1NCT06355232
Covid-19 and Influenza Oral Vaccine Study
A Phase 1 study testing Covid-19 vaccine and Influenza vaccine in people with covid19 Infection and Influenza, Human, run by Vaxine Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- covid19 Infection, Influenza, Human
- What is being tested?
- Covid-19 vaccine and Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
ARASMI
Adelaide, South Australia, 5042
Sharen Pringle, GradCert, 0437033400, office@arasmi.org
Dimitar Sajkov, MBBS
About this study
Official title: A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
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.
Read the detailed description
The SARS-CoV-2 outbreak has caused millions of deaths globally. It has a particularly high mortality rate in elderly people and those with chronic disease. SARS-COV-2 vaccines remain a key priority to help fight the current pandemic as they help reduce symptomatic infection and disease severity. However, vaccine immunity starts to wane as early as 3 months following the most recent immunisation. This rapidly waning vaccine immunity is a particular problem for the newer Omicron variants. Spikogen® vaccine is an Advax-CpG55.2 adjuvanted recombinant protein vaccine that was shown to significantly reduce infection and serious disease in a pivotal Phase 3 trial in 16,876 participants who received two intramuscular doses 3 weeks apart. SpikoGen® vaccine was licensed for use in the Middle East as a primary vaccine course in adults in October 2021. Eight million doses of SpikoGen® vaccine have subsequently been supplied to date. A booster study confirmed the safety and immunogenicity of SpikoGen® vaccine when given as a third dose intramuscular booster to adult participants who previously received two doses of either inactivated viral vaccine, adenoviral vector vaccine, mRNA or recombinant protein vaccine. While COVID-19 vaccines such as SpikoGen® vaccine have been shown to reduce the incidence of severe SARS-CoV-2 infection disease, they have less effect on SARS-CoV-2 infection or transmission. This is because intramuscular vaccines largely work by increasing antibody and T cell levels within the body, whereas what is needed to prevent infection and transmission is mucosal immunity, which means increasing immunity at the body surfaces where the virus initially gets access to the body, namely the mucosal surfaces of the nose and upper respiratory tract. To induce mucosal immunity normally requires immune cells at these respiratory tract surfaces to be exposed to the relevant viral antigen, which requires the vaccine to be applied to these surfaces in such a way as to trigger an appropriate immune response.The current study is based on the finding that an adjuvanted protein-based COVID-19 vaccine (SpikoGen®) when given as 2 sublingual doses 2 weeks apart in monkeys that had previously received a primary course of 2 intramuscular doses of the same vaccine, was safe and well tolerated and induced robust protection against challenge with the heterologous Omicron BA.5 virus. The monkeys that received the sublingual boost also showed reduced nasal virus shedding (additional details in the Investigator Brochure). This suggests an oral/ sublingual COVID-19 vaccine may also help block virus transmission. Similarly, mice that received sublingual inactivated influenza vaccine with Advax-CpG adjuvant have demonstrated robust protection against an otherwise lethal influenza infection. 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.
- Conditions
- covid19 Infection, Influenza, Human
- Being tested
- Covid-19 vaccine, Influenza vaccine
- Keywords
- covid-19, influenza, pandemic, mucosal, spikogen, advax, adjuvant, vaccine
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 vaccineBiological
Also called SARS-CoV-2 vaccine
Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant
Influenza vaccineBiological
Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 vaccine group | Experimental | 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. Receives: Biological: Covid-19 vaccine; Biological: Influenza vaccine |
| Influenza vaccine group | Experimental | 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. Receives: Biological: Covid-19 vaccine; Biological: Influenza vaccine |
| Combined vaccine group | Experimental | 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. Receives: Biological: Covid-19 vaccine; Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 Seroconversion
Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
Measured: Between baseline and 2 weeks post the second dose
Influenza Seroconversion
Proportion of study participants who seroconvert (4-fold or greater rise in hemagglutinin antibody) by primary vaccine group
Measured: Between baseline and 2 weeks post the second dose
SARS-CoV-2 Seroprotection
Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Measured: Between baseline and 2 weeks post the second dose
Influenza Seroprotection
Proportion of study participants who achieve a hemagglutinin neutralisation titer of 40 or greater by primary vaccine group
Measured: Between baseline and 2 weeks post the second dose
SARS-CoV-2 Geometric mean titer fold change
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Measured: Between baseline and 2 weeks post the second dose
Influenza geometric mean titer fold change
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Measured: Between baseline and 2 weeks post the second dose
Safety assessment 1
Frequency of Adverse events by primary vaccine group
Measured: Between time of administration of first dose and through study completion, an average of 10 months
Safety assessment 2
Frequency of Serious Adverse events by primary vaccine group
Measured: Between time of administration of first dose and through study completion, an average of 10 months
SARS-CoV-2 infection
Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
Measured: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Influenza infection
Frequency ofinfluenza infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
Measured: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Secondary outcomes (4)
Antibody durability
The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
Measured: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Seroconversion in participants with and without evidence of past infection
Antibody seroconversion in participants by primary vaccine group
Measured: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Antibody GMT in participants with and without evidence of past infection
Antibody GMT in baseline seropositive versus negative participants by primary vaccine group.
Measured: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Antibody correlates of protection
antibody levels in subjects with or without breakthrough infection
Measured: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for covid19 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, controlled cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaxine Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Australian Respiratory and Sleep Medicine Institute
- Responsible party
- Sponsor
- Investigators
- Dimitar Sajkov, MBBS/PhD, Principal investigator, ARASMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355232
- Sponsor's protocol ID
- Vaxine-2301
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with external researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
- ClinicalTrials.gov ID
- NCT06355232
- Acronym / sponsor ID
- Vaxine-2301
- Conditions
- covid19 Infection, Influenza, Human
- Keywords
- covid-19, influenza, pandemic, mucosal, spikogen, advax, adjuvant, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vaxine Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Australian Respiratory and Sleep Medicine Institute
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The SARS-CoV-2 outbreak has caused millions of deaths globally. It has a particularly high mortality rate in elderly people and those with chronic disease. SARS-COV-2 vaccines remain a key priority to help fight the current pandemic as they help reduce symptomatic infection and disease severity. However, vaccine immunity starts to wane as early as 3 months following the most recent immunisation. This rapidly waning vaccine immunity is a particular problem for the newer Omicron variants. Spikogen® vaccine is an Advax-CpG55.2 adjuvanted recombinant protein vaccine that was shown to significantly reduce infection and serious disease in a pivotal Phase 3 trial in 16,876 participants who received two intramuscular doses 3 weeks apart. SpikoGen® vaccine was licensed for use in the Middle East as a primary vaccine course in adults in October 2021. Eight million doses of SpikoGen® vaccine have subsequently been supplied to date. A booster study confirmed the safety and immunogenicity of SpikoGen® vaccine when given as a third dose intramuscular booster to adult participants who previously received two doses of either inactivated viral vaccine, adenoviral vector vaccine, mRNA or recombinant protein vaccine. While COVID-19 vaccines such as SpikoGen® vaccine have been shown to reduce the incidence of severe SARS-CoV-2 infection disease, they have less effect on SARS-CoV-2 infection or transmission. This is because intramuscular vaccines largely work by increasing antibody and T cell levels within the body, whereas what is needed to prevent infection and transmission is mucosal immunity, which means increasing immunity at the body surfaces where the virus initially gets access to the body, namely the mucosal surfaces of the nose and upper respiratory tract. To induce mucosal immunity normally requires immune cells at these respiratory tract surfaces to be exposed to the relevant viral antigen, which requires the vaccine to be applied to these surfaces in such a way as to trigger an appropriate immune response.The current study is based on the finding that an adjuvanted protein-based COVID-19 vaccine (SpikoGen®) when given as 2 sublingual doses 2 weeks apart in monkeys that had previously received a primary course of 2 intramuscular doses of the same vaccine, was safe and well tolerated and induced robust protection against challenge with the heterologous Omicron BA.5 virus. The monkeys that received the sublingual boost also showed reduced nasal virus shedding (additional details in the Investigator Brochure). This suggests an oral/ sublingual COVID-19 vaccine may also help block virus transmission. Similarly, mice that received sublingual inactivated influenza vaccine with Advax-CpG adjuvant have demonstrated robust protection against an otherwise lethal influenza infection. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised, controlled cross-over study
| Arm | Type | Receives |
|---|---|---|
| Covid-19 vaccine group | Experimental | Biological: Covid-19 vaccine, Biological: Influenza vaccineSubjects 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. |
| Influenza vaccine group | Experimental | Biological: Covid-19 vaccine, Biological: Influenza vaccineSubjects 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. |
| Combined vaccine group | Experimental | Biological: Covid-19 vaccine, Biological: Influenza vaccineSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid-19 vaccineAlso: SARS-CoV-2 vaccineRecombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant | Biological | Combined vaccine group, Covid-19 vaccine group, Influenza vaccine group |
| Influenza vaccineInactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant | Biological | Combined vaccine group, Covid-19 vaccine group, Influenza vaccine group |
Primary outcome
SARS-CoV-2 Seroconversion
Time frame: Between baseline and 2 weeks post the second dose
Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
Influenza Seroconversion
Time frame: Between baseline and 2 weeks post the second dose
Proportion of study participants who seroconvert (4-fold or greater rise in hemagglutinin antibody) by primary vaccine group
SARS-CoV-2 Seroprotection
Time frame: Between baseline and 2 weeks post the second dose
Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Influenza Seroprotection
Time frame: Between baseline and 2 weeks post the second dose
Proportion of study participants who achieve a hemagglutinin neutralisation titer of 40 or greater by primary vaccine group
SARS-CoV-2 Geometric mean titer fold change
Time frame: Between baseline and 2 weeks post the second dose
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Influenza geometric mean titer fold change
Time frame: Between baseline and 2 weeks post the second dose
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Safety assessment 1
Time frame: Between time of administration of first dose and through study completion, an average of 10 months
Frequency of Adverse events by primary vaccine group
Safety assessment 2
Time frame: Between time of administration of first dose and through study completion, an average of 10 months
Frequency of Serious Adverse events by primary vaccine group
SARS-CoV-2 infection
Time frame: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
Influenza infection
Time frame: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Frequency ofinfluenza infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
4 secondary outcomes
Antibody durability
Time frame: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Seroconversion in participants with and without evidence of past infection
Time frame: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Antibody GMT in participants with and without evidence of past infection
Time frame: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Antibody correlates of protection
Time frame: From 2 weeks post the administration of the second dose and through study completion, an average of 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD with external researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dimitar Sajkov, MBBS/PhD principal investigator
ARASMI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Covid-19 vaccine and Influenza vaccine in people with covid19 Infection and Influenza, Human, run by Vaxine Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharen Pringle, GradCert (0437033400, office@arasmi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 Seroconversion (time frame: Between baseline and 2 weeks post the second dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.