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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
81
Recombinant spike protein based Covid-19 vaccine
ARASMI
Adelaide, South Australia, Australia
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 4 weeks post the booster dose
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 4 weeks post the booster dose
Geometric mean titer fold change
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Time frame: Between baseline and 4 weeks post the booster dose
Safety assessment 1
Frequency of Adverse events by primary vaccine group
Time frame: Occurring within 7 days after booster dose.
Safety assessment 2
Frequency of Serious Adverse events by primary vaccine group
Time frame: Between time of administration of booster dose and through study completion, an average of 3 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
Time frame: Between time of administration of booster dose and through study completion, an average of 3 months
Antibody durability
The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
Time frame: Between time of administration of booster dose and through study completion, an average of 3 months
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Seroconversion in participants with and without evidence of past infection
Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Time frame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Seroprotection in participants with and without evidence of past infection
Spike antibody seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Time frame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Spike antibody GMT in participants with and without evidence of past infection
Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group.
Time frame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Antibody correlates of protection
SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection
Time frame: Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months