Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Australian Respiratory and Sleep Medicine Institute | OTHER |
| Cinnagen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpikoGen vaccine | Experimental | Single booster dose of SpikoGen Covid-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpikoGen vaccine | Biological | Recombinant spike protein based Covid-19 vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion | Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group | 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 | 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 | Between baseline and 4 weeks post the booster dose |
| Safety assessment 1 | Frequency of Adverse events by primary vaccine group | Occurring within 7 days after booster dose. |
| Safety assessment 2 | Frequency of Serious Adverse events by primary vaccine group | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody correlates of protection | SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection | Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dimitar Sajkov, MD/PhD | ARASMI | Principal Investigator |
| Nikolai Petrovsky, MD/PhD | Vaxine Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARASMI | Adelaide | South Australia | 5042 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35436611 | Background | 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. | |
| 35758850 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718690 | SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine |
Not provided
Not provided
Not provided
All subjects will receive the same single intervention with analysis groups being based on the type of primary vaccine received
Not provided
Not provided
Not provided
Not provided
| Between time of administration of booster dose and through study completion, an average of 3 months |
| 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 | 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 | 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. | Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months |
| Background |
| 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. |
| 35465982 | Background | 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. |
| 34420786 | Background | 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. |
| 36096430 | Background | 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. |
| 39914274 | Derived | Honda-Okubo Y, Sajkov D, Wauchope B, Turner JV, Vote B, Antipov A, Andre G, Lebedin Y, Petrovsky N. Immunogenicity and safety study of a single dose of SpikoGen(R) vaccine as a heterologous or homologous intramuscular booster following a primary course of mRNA, adenoviral vector or recombinant protein COVID-19 vaccine in ambulatory adults. Vaccine. 2025 Mar 7;49:126744. doi: 10.1016/j.vaccine.2025.126744. Epub 2025 Feb 5. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |