Booster Study of SpikoGen COVID-19 Vaccine

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05542862
• Other study ID #: AUST-C19-booster
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 7, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Vaxine Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• SpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine

Locations

Country	Name	City	State
Australia	ARASMI	Adelaide	South Australia

Sponsors (3)

Lead Sponsor	Collaborator
Vaxine Pty Ltd	Australian Respiratory and Sleep Medicine Institute Ltd, Cinnagen

Country where clinical trial is conducted

Australia, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Safety assessment 1	Frequency of Adverse events by primary vaccine group	Occurring within 7 days after booster dose.
Primary	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
Primary	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
Primary	Antibody durability	The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.	Between time of administration of booster dose and through study completion, an average of 3 months
Primary	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
Primary	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
Primary	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
Secondary	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