COVID-19
Conditions
Keywords
covid-19, vaccine, adjuvant, Spikogen, Advax, CpG55.2
Brief summary
The purpose of the study is to assess the effectiveness of Spikogen vaccine when used as a 3rd or 4th dose booster in adults who have been previously vaccinated with any Covid-19 vaccine types, including mRNA vaccine, adenoviral vector vaccines, recombinant protein vaccines, or inactivated virus vaccines.
Detailed description
Currently in Australia, mRNA, adenoviral vector and recombinant protein vaccines have provisional approval for use as 3rd or 4th booster doses. This study will provide important data on the use of Spikogen as an alternative recombinant protein booster vaccine. The study will provide data in ambulatory adults on the safety and effectiveness of Spikogen vaccine when administered as a single intramuscular booster dose in those who previously vaccinated with mRNA vaccine in comparison to those immunised with other Covid-19 vaccine platforms.
Interventions
BIOLOGICALSpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine
Sponsors
Australian Respiratory and Sleep Medicine Institute Ltd
Cinnagen
Vaxine Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All subjects will receive the same single intervention with analysis groups being based on the type of primary vaccine received
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to provide written informed consent * Males or females 18 years of age or older * Have previously had a primary course of Covid-19 vaccine with the most recent dose no less than 3 months previously. * Understand and are likely to comply with planned study procedures and be available for all study visits.
Exclusion criteria
* Allergy to Spikogen vaccine or one of its components, e.g. polysorbate 80. * Have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spike antibody GMT in participants with and without evidence of past infection | Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months | Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group. |
| Seroconversion | Between baseline and 4 weeks post the booster dose | Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group |
| Seroprotection | Between baseline and 4 weeks post the booster dose | Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group |
| Geometric mean titer fold change | Between baseline and 4 weeks post the booster dose | Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group |
| Safety assessment 1 | Occurring within 7 days after booster dose. | Frequency of Adverse events by primary vaccine group |
| Safety assessment 2 | Between time of administration of booster dose and through study completion, an average of 3 months | Frequency of Serious Adverse events by primary vaccine group |
| SARS-CoV-2 infection | Between time of administration of booster dose and through study completion, an average of 3 months | Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection |
| Antibody durability | Between time of administration of booster dose and through study completion, an average of 3 months | The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group. |
| Seroconversion in participants with and without evidence of past infection | Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months | Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group |
| Seroprotection in participants with and without evidence of past infection | Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months | Spike antibody seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody correlates of protection | Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months | SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection |
Countries
Australia
Outcome results
None listed