Covid-19 and Influenza Oral Vaccine Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVaxine Pty Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Covid-19 vaccine
Biological/VaccineRecombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant
Influenza vaccine
Biological/VaccineInactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Covid-19 vaccine groupExperimental treatment 2 interventions
Group B: Influenza vaccine groupExperimental treatment 2 interventions
Group C: Combined vaccine groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
SARS-CoV-2 Seroconversion
Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
Time frame
Between baseline and 2 weeks post the second dose2
Influenza Seroconversion
Proportion of study participants who seroconvert (4-fold or greater rise in hemagglutinin antibody) by primary vaccine group
Time frame
Between baseline and 2 weeks post the second dose3
SARS-CoV-2 Seroprotection
Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Time frame
Between baseline and 2 weeks post the second dose4
Influenza Seroprotection
Proportion of study participants who achieve a hemagglutinin neutralisation titer of 40 or greater by primary vaccine group
Time frame
Between baseline and 2 weeks post the second doseSecondary outcomes
1
Antibody durability
The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
Time frame
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months2
Seroconversion in participants with and without evidence of past infection
Antibody seroconversion in participants by primary vaccine group
Time frame
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months3
Antibody GMT in participants with and without evidence of past infection
Antibody GMT in baseline seropositive versus negative participants by primary vaccine group.
Time frame
From 2 weeks post the administration of the second dose and through study completion, an average of 10 months4
Antibody correlates of protection
antibody levels in subjects with or without breakthrough infection
Time frame
From 2 weeks post the administration of the second dose and through study completion, an average of 10 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vaxine Pty Ltd
Lead sponsor
Australian Respiratory and Sleep Medicine Institute
Collaborator
Source ClinicalTrials.gov