Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine

NCT05148871 | Active Not Recruiting Phase 2

• 1 other identifier: C19-P2/3B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A study to assess the effect of varying the time interval between doses on the immunogenicity of an adjuvanted recombinant spike protein Covid-19 vaccine (Spikogen/Covax-19)

Conditions

COVID-19

Keywords

covid-19; SARS-CoV-2; coronavirus; vaccine; adjuvant; Advax

Outcome Measures

Primary Outcomes (3)

• Spike antibody immunogenicity

  Serum geometric mean titers of anti-spike protein antibody levels

  3 weeks post second vaccine dose

• Spike antibody seroconversion

  Proportion of each group seroconverting to spike protein antibody positiivity

  3 weeks post second vaccine dose

• SARS-CoV-2 protection

  Confirmed Covid-19 infections

  Accrual of events starting 2 weeks post second vaccine dose

Secondary Outcomes (2)

• Spike antibody durability

  6 months post-second vaccine dose

• Spike antibody seropositive persistence

  6 months post-second vaccine dose

Study Arms (4)

3 week arm

ACTIVE COMPARATOR

Subjects will receive two doses of vaccine 3 weeks apart

Biological: Spikogen/Covax-19

4 week arm

ACTIVE COMPARATOR

Subjects will receive two doses of vaccine 4 weeks apart

Biological: Spikogen/Covax-19

5 week arm

ACTIVE COMPARATOR

Subjects will receive two doses of vaccine 5 weeks apart

Biological: Spikogen/Covax-19

6 week arm

ACTIVE COMPARATOR

Subjects will receive two doses of vaccine 6 weeks apart

Biological: Spikogen/Covax-19

Interventions

Spikogen/Covax-19 BIOLOGICAL

Spikogen/Covax-19 is a recombinant spike protein vaccine formulated with Advax-CpG55.2 adjuvant

3 week arm; 4 week arm; 5 week arm; 6 week arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to initiation of any study procedures.
• No history of previous Covid-19 vaccinations
• Women of childbearing potential must use an acceptable contraception method from at least 28 days before study vaccination until 14 days after last study vaccination.
• Understand and comply with planned study procedures and be available for all study visits.

You may not qualify if:

• Have a history of severe systemic reactions (anaphylaxis, breathing difficulties, severe rash) following previous immunization with licensed or unlicensed vaccines.
• Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period.
• Intend to receive another Covid-19 vaccine during the time of the study

Sponsors & Collaborators

• Vaxine Pty Ltd: lead
• Australian Respiratory and Sleep Medicine Institute: collaborator
• Cinnagen: collaborator

Study Sites (1)

ARASMI

Adelaide, South Australia, 5042, Australia

Location

Related Publications (3)

• 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.

  PMID: 34420786 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.

  PMID: 35436611 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.

  PMID: 35465982 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dimitar Sajkov, MD, PhD

  ARASMI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomised into 4 groups, where the only difference will be the time between vaccine doses (3, 4, 5 or 6 weeks)

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 8, 2021
• Study Start: March 1, 2022
• Primary Completion: February 23, 2023
• Study Completion: October 6, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)