Covid-19 and Influenza Oral Vaccine Study

NCT06355232 | Recruiting Phase 1

• 1 other identifier: Vaxine-2301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

covid19 Infection; Influenza, Human

Keywords

covid-19; influenza; pandemic; mucosal; spikogen; advax; adjuvant; vaccine

Outcome Measures

Primary Outcomes (10)

• SARS-CoV-2 Seroconversion

  Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group

  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

  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

  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

  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

  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

  Between baseline and 2 weeks post the second dose

• Safety assessment 1

  Frequency of Adverse events by primary vaccine group

  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

  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

  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

  From 2 weeks post the administration of the second dose and through study completion, an average of 10 months

Secondary Outcomes (4)

• Antibody durability

  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

  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

  From 2 weeks post the administration of the second dose and through study completion, an average of 10 months

• Antibody correlates of protection

  From 2 weeks post the administration of the second dose and through study completion, an average of 10 months

Study Arms (3)

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.

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.

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.

Biological: Covid-19 vaccine; Biological: Influenza vaccine

Interventions

Covid-19 vaccine BIOLOGICAL

Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant

Also known as: SARS-CoV-2 vaccine

Combined vaccine group; Covid-19 vaccine group; Influenza vaccine group

Influenza vaccine BIOLOGICAL

Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant

Combined vaccine group; Covid-19 vaccine group; Influenza vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaxine Pty Ltd: lead
• Australian Respiratory and Sleep Medicine Institute Ltd: collaborator

Study Sites (1)

ARASMI

Adelaide, South Australia, 5042, Australia

RECRUITING

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

COVID-19 Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Dimitar Sajkov, MBBS/PhD

  ARASMI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharen Pringle, GradCert

CONTACT

0437033400; office@arasmi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A comparator vaccine (influenza) with an identical appearance will be used as the control.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, controlled cross-over study

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 9, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)