Delving into the Latest Updates on COVAX 19 with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Adjuvanted COVID2019 vaccine Vaxine, COVAX19 vaccine, SpikoGen

Target

SARS-CoV-2 S protein

Action

inhibitors

Mechanism

SARS-CoV-2 S protein inhibitors(SARS-CoV-2 S protein inhibitors)

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

COVID-19Influenza, Human

Inactive Indication

Severe Acute Respiratory Syndrome

Originator Organization

Vaxine Pty Ltd.

Active Organization

CinnaGen Co.

Vaxine Pty Ltd.

Inactive Organization-

License Organization

Medytox Inc.

Prestige BioPharma Ltd.

Mabion SA

+ [1]

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines.

Start Date01 May 2024

Sponsor / Collaborator

Vaxine Pty Ltd.

NCT05542862

/ Active, not recruitingPhase 3

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

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.

Start Date07 Sep 2022

Sponsor / Collaborator

Vaxine Pty Ltd.

[+1]

NCT05148871

/ Active, not recruitingPhase 2/3

A Phase 2b Study to Assess the Effect of Dose Interval on the Effectiveness of a Protein-based Covid-19 Vaccine (Spikogen® Vaccine)

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)

Start Date01 Mar 2022

Sponsor / Collaborator

Vaxine Pty Ltd.

[+1]

100 Clinical Results associated with COVAX 19

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100 Translational Medicine associated with COVAX 19

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100 Patents (Medical) associated with COVAX 19

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18

Literatures (Medical) associated with COVAX 19

01 Mar 2025·Vaccine

Immunogenicity and safety study of a single dose of SpikoGen® 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

Article

Author: Wauchope, Bruce ; André, Greiciely ; Vote, Brendan ; Honda-Okubo, Yoshikazu ; Lebedin, Yuri ; Sajkov, Dimitar ; Petrovsky, Nikolai ; Turner, Joseph V ; Antipov, Anna

BACKGROUNDSpikoGen® is a subunit recombinant Wuhan spike protein produced in insect cells and formulated with Advax-CpG55.2™ adjuvant. It is approved for adult and pediatric use in the Middle East. This study tested the safety and immunogenicity of SpikoGen® as a 3rd, 4th or 5th dose booster following a primary immunisation course of mRNA, adenovirus or SpikoGen® vaccine.METHODSThe trial recruited participants who had received a previous doses of COVID-19 vaccine more than 3 months prior. Each received a single intramuscular booster dose of SpikoGen® vaccine. Spike and nuclear protein antibody levels were measured at 1 and 3 months post-booster, together with collection of data on SARS-CoV-2 breakthrough infections and symptoms of long COVID.RESULTSOne-month post-booster, anti-spike IgG, sVNT, and pVNT levels were increased in all groups and there was ∼4-fold neutralizing antibodies against the heterologous Omicron BA.2 and BA.4/5 strains. The SpikoGen®-prime group had the highest levels of anti-spike IgG3, consistent with the Advax-CpG adjuvant driving IgG3 induction. There was no effect of age on the vaccine response. The booster dose was well tolerated with no vaccine-associated serious adverse events. Nine participants (9/74, 12.2 %) had a breakthrough SARS-CoV-2 infection between 2 weeks and 3 months post-booster. No long COVID was observed after breakthrough infections. Breakthrough infection was negatively correlated with baseline anti-nuclear protein IgG seropositivity.CONCLUSIONA single SpikoGen® booster was well tolerated and stimulated cross- antibody responses against Omicron variants, regardless of the primary vaccine course received. With SARS-CoV-2 variants continuing to evolve, ongoing research is needed into optimum booster strategies.CLINICALTRIALSgov registration. NCT05542862.

01 Jan 2025·Human Immunology

Evaluation of anti-SARS-CoV-2 RBD antibody response after booster dose of SpikoGen® in individuals with two previous doses of Sinopharm and its association with HLA-DR and -DQ alleles

Article

Author: Hajijafary, Amir Hossein ; Bemani, Peyman ; Feizi, Awat ; Malekmohammad, Somayeh

BACKGROUNDIt has been demonstrated that COVID-19 vaccines confer significant protection, but temporal decay in the vaccine-induced antibodies has been reported; therefore, a third booster dose was considered. Human leukocyte antigen (HLA) class II molecules act as antigen presenting structures, play critical roles in the formation of an efficient antibody response. The current study aimed to evaluate the anti-receptor binding domain (RBD) antibody response after the booster dose of SpikoGen® vaccine in individuals with a history of Sinopharm primary vaccination series and its association with HLA-DQB1 and -DRB alleles.METHODSWhole blood samples were drawn from 95 eligible individuals before and three weeks after the booster dose of SpikoGen®. Quantitative measurement of anti-RBD IgG and qualitative assessment of anti-RBD IgA was performed using the ELISA method and HLA-DQB1 and -DRB loci were genotyped by low-resolution SSP-PCR method.RESULTSA significant increase was observed in the anti-RBD IgG antibodies after the booster dose of SpikoGen® (baseline: 1.82 ± 0.55 GMT, after: 2.28 ± 0.36 GMT)(P < 0.0001). The median fold change of anti-RBD IgG antibodies for DRB1*14 positive individuals (3.96 (1.47-31.75)) was significantly higher than DRB1*14 negative people (1.18 (1.08-1.34))(P = 0.008). In addition, the median fold change of anti-RBD IgG antibodies for DQB1*04 positive individuals (1.39 (1.21-3.43)) was higher than those which were DQB1*04 negative (1.18 (1.08-1.34)), however it was marginally significant (P = 0.060). The seroconversion incidence for anti-RBD IgA antibodies was 68.42 %.CONCLUSIONIn conclusion, our study showed that the booster dose of SpikoGen® can elicit a robust anti-RBD antibody response which was positively associated with DRB1*14 allele.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine

Review

Author: Petrovsky, Nikolai

Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is a recombinant spike protein trimer manufactured in insect cells and formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret and non-human primate studies, SpikoGen® consistently provided protection against a range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability of SpikoGen® to prevent infection and severe disease caused by the virulent Delta strain. SpikoGen® subsequently received a marketing authorization from the Iranian FDA in early October 2021 for prevention of COVID-19 in adults. Following a successful pediatric study, its approval was extended to children 5 years and older. Eight million doses of SpikoGen® have been delivered, and a next-generation booster version is currently in development. This highlights the benefits of adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected for future pandemics.

100 Deals associated with COVAX 19

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 1	Australia	Vaxine Pty Ltd.	01 May 2024
COVID-19	Discovery	United States	CinnaGen Co.	23 Feb 2022
Severe Acute Respiratory Syndrome	Discovery	Australia	Vaxine Pty Ltd.	30 Jun 2020