Clinical trial NCT05279456: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)
Official title: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: COVID-19
Keywords: sars-cov-2
coronavirus
vaccine
adjuvant
Advax
Spikogen
Covax-19
Lead sponsor: Vaxine Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Australian Respiratory and Sleep Medicine Institute
First posted: 2022-03-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be stratified for analysis by age, sex and seropositivity at time of study entry
Primary purpose: PREVENTION

Brief summary: This study will determine the immunogenicity of Spikogen in vaccine naïve individuals. Spikogen will be administered as two doses 1 month apart with a third booster dose either 1 or 3 months after the second dose. This study will provide key data on SARS-CoV-2 antibody responses.

Detailed description: The SARS-CoV-2 outbreak has caused millions of deaths globally. It has a particularly high mortality rate in elderly people and those with chronic disease where mortality rates can be as high as 20-30%. SARS-COV-2 vaccines remain a key priority to help fight the current pandemic. COVID-19 vaccines prevent symptomatic infection and may help reduce virus transmission. Spikogen® vaccine, also known as Covax-19™ in Australia, is an adjuvanted recombinant protein Covid-19 vaccine has recently been approved by the Iranian FDA for emergency use in Iran in adults as a primary vaccine course and booster dose, after meeting its primary efficacy endpoint in a Phase 3 trial in 16,876 participants randomised 3:1 to receive Spikogen vaccine or saline placebo via two intramuscular doses 3 weeks apart where Spikogen vaccine demonstrated significant protection against serious infection with the delta variant. Approximately 5-10% of the broader Australian population and an even higher proportion of the indigenous populations remains unvaccinated despite current availability of these vaccines. One reason is that some people have medical contraindications to the current vaccines, such as serious allergies to the vaccine components such as polyethyleneglycol (PEG) in the mRNA vaccines.

Spikogen vaccine is made using a recombinant protein approach with the SARS-CoV-2 spike protein synthesized in an insect cell line grown in broth. Insect cell expression of recombinant protein is a well-established vaccine manufacturing approach. Spikogen vaccine also contains a unique Australian developed adjuvant called Advax-CpG55.2, which is added to the spike protein to make the vaccine more effective. AdvaxCpG55.2 has two components, one a natural plant sugar called inulin, and the second a short synthetic oligonucleotide polymer, known as CpG55.2 oligonucleotide.

Spikogen vaccine is designed to protect against SARS-CoV-2 infection. It has been shown to be effective against infection in hamster, ferret and monkey SARS-CoV-2 infection models.

This study will determine the immunogenicity of Spikogen in vaccine-naïve individuals. Spikogen will be administered as two doses 31 month apart with a third booster dose given either 1 or 3 months after the second dose.

Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Males or females\* 18 years of age or older
* Understand and are likely to comply with planned study procedures and be available for all study visits.
* Have not previously had a Covid-19 vaccine and do not intend to have a non-study Covid-19 vaccine within the next 6 months

Exclusion Criteria:

* History of Covid-19 vaccination.
* History of serious vaccine allergy.
* Pregnancy1
* 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 medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Primary outcomes:
measure: First dose Seroconversion
timeFrame: 2-4 weeks post first immunisation
measure: Second dose Seroconversion
timeFrame: 2-4 weeks post second immunisation
measure: Third Dose Seroconversion
timeFrame: 2-4 weeks post third immunisation
measure: Final Seroconversion
timeFrame: through study completion, an average of 7 months
measure: First Dose GMT
timeFrame: 2-4 weeks post first immunisation
measure: Second Dose GMT
timeFrame: 2-4 weeks post second immunisation
measure: Third Dose GMT
timeFrame: 2-4 weeks post third immunisation
measure: Final GMT
timeFrame: through study completion, an average of 7 months
measure: First Dose Adverse events (AE)
timeFrame: 7 days post first immunisation
measure: Second Dose Adverse events (AE)
timeFrame: 7 days post second immunisation
measure: Third Dose Adverse events (AE)
timeFrame: 7 days post third immunisation
measure: Serious adverse events (SAE)
timeFrame: through study completion, an average of 7 months
Secondary outcomes:
measure: First dose Vaccine efficacy
timeFrame: From 2 weeks post-first dose to 2 weeks after second dose
measure: Second dose Vaccine efficacy
timeFrame: From 2 weeks post-second dose to 2 weeks after third dose
measure: Third dose Vaccine efficacy
timeFrame: From 2 weeks post-third dose through study completion, an average of 7 months
measure: Total Covid-19 infections
timeFrame: From first vaccine dose through study completion, an average of 7 months
measure: Seroconversion against variants of concern
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
measure: GMT against variants of concern
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
Other outcomes:
measure: Antibody kinetics
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
measure: Age effects on seroconversion
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
measure: Age effects on antibody levels
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
measure: immune-deficiency effects on seroconversion
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
measure: immune-deficiency effects on antibody levels
timeFrame: 2-4 weeks post first, second and third immunisation and at study completion
Locations:
city: Adelaide
country: Australia
facility: ARASMI
state: South Australia
Study officials:
affiliation: ARASMI
name: Dimitar Sajkov, MBBS
role: STUDY_DIRECTOR
References:
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.