Covid-19 vaccine: Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant
Influenza vaccine: Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
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.
Primary outcome measure(s)
SARS-CoV-2 Seroconversion — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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