Clinical trial NCT05542862: Booster Study of SpikoGen COVID-19 Vaccine
Official title: Immunogenicity and Safety Study in Ambulatory Adults of a Single Intramuscular Dose of SpikoGen Vaccine as a Heterologous or Homologous Booster Dose Following Completion of a Primary Course of Covid-19 Vaccine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: COVID-19
Keywords: covid-19
vaccine
adjuvant
Spikogen
Advax
CpG55.2
Lead sponsor: Vaxine Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Australian Respiratory and Sleep Medicine Institute Ltd
name: Cinnagen
First posted: 2022-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive the same single intervention with analysis groups being based on the type of primary vaccine received
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Seroconversion
timeFrame: Between baseline and 4 weeks post the booster dose
measure: Seroprotection
timeFrame: Between baseline and 4 weeks post the booster dose
measure: Geometric mean titer fold change
timeFrame: Between baseline and 4 weeks post the booster dose
measure: Safety assessment 1
timeFrame: Occurring within 7 days after booster dose.
measure: Safety assessment 2
timeFrame: Between time of administration of booster dose and through study completion, an average of 3 months
measure: SARS-CoV-2 infection
timeFrame: Between time of administration of booster dose and through study completion, an average of 3 months
measure: Antibody durability
timeFrame: Between time of administration of booster dose and through study completion, an average of 3 months
measure: Seroconversion in participants with and without evidence of past infection
timeFrame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
measure: Seroprotection in participants with and without evidence of past infection
timeFrame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
measure: Spike antibody GMT in participants with and without evidence of past infection
timeFrame: Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Secondary outcomes:
measure: Antibody correlates of protection
timeFrame: Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: ARASMI
state: South Australia
Study officials:
affiliation: ARASMI
name: Dimitar Sajkov, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vaxine Pty Ltd
name: Nikolai Petrovsky, MD/PhD
role: STUDY_DIRECTOR
References:
citation: Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Roshanzamir K, Bayatani B, Taheri A, Petrovsky N, Li L, Barati S. Safety and immunogenicity of SpikoGen(R), an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations. Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
citation: Tabarsi P, Anjidani N, Shahpari R, Roshanzamir K, Fallah N, Andre G, Petrovsky N, Barati S. Immunogenicity and safety of SpikoGen(R), an adjuvanted recombinant SARS-CoV-2 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo-controlled trial. Immunology. 2022 Nov;167(3):340-353. doi: 10.1111/imm.13540. Epub 2022 Jul 13.
citation: Li L, Honda-Okubo Y, Baldwin J, Bowen R, Bielefeldt-Ohmann H, Petrovsky N. Covax-19/Spikogen(R) vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters. Vaccine. 2022 May 20;40(23):3182-3192. doi: 10.1016/j.vaccine.2022.04.041. Epub 2022 Apr 18.
citation: Li L, Honda-Okubo Y, Huang Y, Jang H, Carlock MA, Baldwin J, Piplani S, Bebin-Blackwell AG, Forgacs D, Sakamoto K, Stella A, Turville S, Chataway T, Colella A, Triccas J, Ross TM, Petrovsky N. Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection. Vaccine. 2021 Sep 24;39(40):5940-5953. doi: 10.1016/j.vaccine.2021.07.087. Epub 2021 Aug 3.
citation: Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Kafi H, Fallah N, Ebrahimi A, Taheri A, Petrovsky N, Barati S. Evaluating the efficacy and safety of SpikoGen(R), an Advax-CpG55.2-adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial. Clin Microbiol Infect. 2023 Feb;29(2):215-220. doi: 10.1016/j.cmi.2022.09.001. Epub 2022 Sep 10.