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.

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]

NCT05231590 / CompletedPhase 3

A Non-Randomized, Three-Armed, Open-Label, Parallel-Group, Non-Inferiority Trial to Compare the Immunogenicity and Safety of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Children Aged 5 to <12 Years and 12 to <18 Years With Adults Aged 18 to 40 Years

This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in children aged 5 to <12 years and 12 to <18 years with adults aged 18 to 40 years. Children aged 12 to <18 years and adults received 25 µg of the recombinant protein together with 15 mg of Advax-SM. Children aged 5 to <12 years received a half-dose of the adjuvanted vaccine. The injection was given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The vaccine immunogenicity was evaluated at 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Unsolicited adverse events were collected through one month after the second dose. Safety monitoring was continued through six months after the second dose in children aged 5 to <12 years and 12 to <18 years.

Start Date23 Feb 2022

Sponsor / Collaborator

CinnaGen Co.

[+1]

100 Clinical Results associated with COVAX 19

100 Translational Medicine associated with COVAX 19

100 Patents (Medical) associated with COVAX 19

Literatures (Medical) associated with COVAX 19

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.

12 Mar 2024·Iranian journal of immunology : IJI

Comparative Immunogenicity and Neutralization Potency of Four Approved COVID-19 Vaccines in BALB/c Mice.

Article

Author: Jeddi-Tehrani, Mahmood ; Shokri, Fazel ; Amiri, Mohammad Mehdi ; Zarnani, Amir-Hassan ; Dashti, Navid ; Golsaz-Shirazi, Forough

Background:

Since the outbreak of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several vaccine candidates have been developed within a short period of time. Although the potency of these vaccines was evaluated individually, their comparative potency was not comprehensively evaluated.

Objective:

To compare the immunogenicity and neutralization efficacy of four approved COVID-19 vaccines in Iran, including: PastoCovac Plus, Sinopharm, SpikoGen, and Noora in BALB/c mice.

Methods:

Different groups of female BALB/c mice were vaccinated with three doses of each vaccine. The serum levels of antibodies against the viral receptor binding domain (anti-RBD) and spike (anti-spike) protein as well as the vaccine formulation (anti-vaccine) were evaluated using enzyme-linked immunosorbent assay (ELISA). The neutralization efficacy of these four vaccines was assessed through four neutralization assays: conventional virus neutralization test (cVNT), pseudotype virus neutralization test (pVNT), surrogate virus neutralization test (sVNT), and inhibition flow cytometry.

Results:

All four vaccines induced seroconversion in vaccinated animals. All vaccines successfully induced high levels of anti-vaccine antibody; however, PastoCovac Plus and Sinopharm vaccines induced significantly higher levels of anti-RBD antibody titer compared to Noora and SpikoGen. Moreover, the results of the antibody response were corroborated by the virus neutralization tests, which revealed very weak neutralization potency by Noora and SpikoGen in all tests.

Conclusion:

Our results indicate significant immunogenicity and neutralization efficacy induced by PastoCovac Plus and Sinopharm, but not by Noora and SpikoGen. This suggests the need for additional comparative assessment of the potency and efficacy of these four vaccines in vaccinated subjects.

01 Feb 2024·Health science reports

Economic evaluation of vaccination against COVID‐19: A systematic review

Article

Author: Zeinab, Dolatshahi ; Shahin, Nargesi ; Saeed, Bagheri Faradonbeh ; Fateme, Mezginejad

Abstract:

Background and Aims:

Coronavirus has burdened considerable expenditures on the different health systems. Vaccination programs, the critical solution against pandemic diseases, are known as safe and effective interventions to prevent and control epidemics. We aimed to perform a systematic review to provide economic evidence of the value of different types of vaccines available to combat the Covid‐19 to all health policymakers worldwide.

Methods:

Electronic searches conducted on Medline/PubMed, Cochrane Library, Web of Science, Scopus, Embase, and other economic evaluation databases. Related and published articles searched up to March 2022 by using keywords such as “Vaccination,” “Covid‐19,” “Cost‐benefit,” “Cost‐utility,” “Cost‐effectiveness,” “Economic Assessment,” and “Economic evaluation.” Followed by choosing the most suitable articles according to inclusion and exclusion criteria, data captured and the results extracted. The quality assessment of the articles performed by the checklist of CHEERS 2022. Finally, 13 articles included in the review.

Results:

All messenger RNA vaccines were dominant with approximately 70% coverage against no vaccination in the primary vaccination program except in one study that looked at booster effects. From a payer's perspective, a dollar invested in a vaccine would be less profitable than from a societal perspective. Therefore, primary mass vaccination can be considered a cost‐effective intervention in primary vaccination to save more lives and produce more positive externalities. However, the cost‐benefit ratio for all vaccines increases when statistical lifetime value and global economic and educational disadvantages are considered.

Conclusion:

The COVID‐19 primary vaccination programs in regional outbreaks, from a long‐term perspective, will demonstrate substantial cost‐effectiveness. It is suggested that due to the positive externalities of vaccination, primary mass vaccination, with the help of COVAX‐19TM, could be considered a reliable way to combat viral epidemics compared to the loss of individual lives and economic and educational disturbances around the world.

100 Deals associated with COVAX 19

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	AU	Vaxine Pty Ltd.	07 Sep 2022
COVID-19	Phase 3	AU	CinnaGen Co.	07 Sep 2022
Influenza, Human	Phase 1	AU	Vaxine Pty Ltd.	01 May 2024
Severe Acute Respiratory Syndrome	Phase 1	AU	Vaxine Pty Ltd.	30 Jun 2020

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