Phase 2 trial of ChulaCov19 BNA159 mRNA Vaccine to start in Australia
ChulaCov19 BNA159 is a COVID-19 mRNA vaccine developed by Chulalongkorn University and produced by BioNet
- ChulaCov19 mRNA vaccine was found safe and immunogenic for primary immunization in clinical trials in Thailand.
- The Australian trial will evaluate the safety and immunogenicity of a booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers.
- The collaborators of the trial are Chulalongkorn University, BioNet and Technovalia.
Melbourne, 15th November 2022 – Technovalia, Chulalongkorn University and BioNet today announced that Human Research Ethics Committee (HREC) in Australia approved the phase 2 trial of ChulaCov19 BNA159 mRNA vaccine as a booster dose in adults.
Ethics approval is granted to commence a phase 2 trial after sharing satisfactory results of clinical safety and immunogenicity data of prior phase 1 and 2 studies of ChulaCov19 mRNA vaccine.
Technovalia announces that its strategic partner BioNet has published in Vaccines the results of the phase 2 trial evaluating PTgen-containing vaccines in women of childbearing age (WOCBA).
In collaboration with PATH and financial support from the Bill & Melinda Gates Foundation, a phase 2 randomized-controlled safety and immunogenicity trial evaluating different doses of recombinant acellular pertussis vaccine containing genetically-inactivated pertussis toxin (PTgen) was conducted in women of childbearing age in Thailand to identify formulations to advance to a trial in pregnant women.
Conclusions: All recombinant acellular pertussis vaccines were safe and immunogenic in women of childbearing age, and all met pre-defined immunogenicity criteria to advance to a trial in pregnant women.
BioNet’s PTgen-containing vaccine Pertagen® is currently being tested in the Pertaprime study, a phase 2/3 trial in healthy adults aged 18 – 25 years old in Western Australia.
Technovalia, Sypharma and BioNet announce the establishment of Genetis, the first Australian Vaccine Development and Manufacturing Hub for mRNA, DNA and recombinant vaccines.
Establishment of the first end-to-end Australian capability for product development and commercial scale production of mRNA, DNA and recombinant vaccines
By bringing together the technology, product development, GMP manufacturing, clinical and regulatory expertise of key consortium partners Technovalia, Sypharma and BioNet, Genetis will provide a unique Australian-based vaccine contract and product development manufacturing hub for Australian and offshore research organisations seeking access to quality capability and TGA approved products.
The founding partners have been sharing common interest and commitment in the fight against the COVID-19 pandemic through the rapid development, production and/or evaluation of several COVID vaccines. BioNet has established a strong DNA and mRNA manufacturing platform and produced vaccines candidates in clinical development stage. Technovalia has initiated the first needle-free DNA COVID vaccine trial in Australia, and Sypharma has been involved in the fill-finish and manufacture of several COVID vaccine candidates.
Technovalia’s vaccine manufacturing partner BioNet leading consortium to develop SARS-CoV-2 variant-proof mRNA vaccine.
CEPI will support the researchers of a global and multidisciplinary consortium led by BioNet and composed of American and Thai universities (Pennsylvania, North Carolina, California-Davis and Chulalongkorn) and South Korea-based International Vaccine Institute as they seek to establish preclinical and clinical proof of concept for a novel vaccine that uses multiple mRNA molecules that encode for several SARS-CoV-2 target proteins (ie, immunogens) from different variants, which could provide broad protection against SARS-CoV-2 variants. To protect the fragile mRNA molecules, they are then encapsulated into a fatty sphere, known as a lipid nanoparticle for use as a vaccine.
Read the full article online at here.
COVALIA study update: Interim Safety Results from needle-free SARS-CoV2 DNA vaccine phase 1 trial
- First needle-free SARS-CoV2 DNA vaccine tested in Australia is well tolerated
- No safety concerns were observed
- Ongoing study enrolment for booster dose
Melbourne 17 January 2022 –Technovalia, an Australian biotech vaccine developer today announced the interim safety results of the ongoing phase 1 clinical trial evaluating COVIGEN, a DNA Covid-19 vaccine candidate, in healthy participants using the PharmaJet® Needle-free Devices.
Interim safety data showed that Covigen is well tolerated and no safety concerns were observed. Full safety data are expected by February 2022. The phase 1 trial involved 27 participants to assess the safety and immunogenicity of two COVIGEN doses given to healthy volunteers who had not yet had a COVID-19 vaccine. The trial is ongoing, now recruiting in three states across Australia (NSW, SA, and WA) for the evaluation of COVIGEN as a booster on volunteers having received two doses of the available vaccines in Australia. Participants are being recruited by Scientia Clinical Research (Sydney), the Telethon Kids Institute (Perth) and the Women’s and Children’s Hospital (Adelaide).
Based on wide-ranging industry discussions, the New York Times ranked BioNet 5th/10 companies globally capable of mRNA manufacture based on suitable production facilities, the availability of skilled workers, the history of drug regulation and certification for drug export, and other political and economic factors that affect research and trade.
BioNet is producing the Ph 2/3 mRNA vaccine developed by Professor Kiat of Chulalongkorn University and Professor Drew Weissman of the University of Pennsylvania. It also produces Covigen, a DNA Covid vaccine developed with Technovalia and Sydney University, currently in Phase 1 trials in Australia.
Read the full NYT article online at here.
Ajdovščina, Slovenia & Bangkok, Thailand, 02 November 2021: BioNet, a leading biotech company manufacturing genetically engineered vaccines, and BIA Separations, now part of Sartorius, a leading biochromatography development and manufacturing company, today announced the successful development of an optimized mRNA manufacturing process.
BIA’s expertise in chromatographic columns for mRNA purification combined with BioNet’s expertise in the product development of genetic vaccines have, since early 2021, enabled both teams to collaborate on the optimization and upscale of a high-yield mRNA production process.
The new process has been successfully applied to the production of mRNA in the fight against COVID- 19. The mRNA vaccine, produced at BioNet’s manufacturing facility, was developed by Chula Vaccine Research Center, Thailand in collaboration with the University of Pennsylvania, US.
Both BIA and BioNet are now collaborating on other projects aiming to increase development capabilities and production capacity of nucleic acid vaccines in Europe, Australia, and low-middle income countries.
Antibody persistence 2 and 3 years after booster vaccination of adolescents with recombinant acellul
Antibody persistence 2 and 3 years after booster vaccination of adolescents with recombinant acellular pertussis monovalent aPgen or combined TdaPgen vaccines
"In summary, new generation recombinant acellular pertussis booster vaccines, available as a pertussis-only and in combination with tetanus and diphtheria, are associated with stabilizing PT antibody responses at levels 2 and 3 years after vaccination that are well above pre-vaccination. It may therefore be expected that the duration of immune protection and hence vaccine effectiveness induced by this new generation recombinant pertussis vaccine is longer than that of currently used chemically detoxified Tdap booster vaccines."
COVALIA study update: first healthy volunteers dosed in needle-free SARS-CoV2 DNA vaccine phase 1 trial
First needle-free SARS-CoV2 DNA vaccine to be tested in Australia in a phase 1 trial in healthy subjects aged 18 to 75 years old
Melbourne _ 30th June 2021 – Australian biotech company Technovalia is pleased to announce that the first volunteers have been enrolled and dosed in the COVALIA trial, a phase 1 study of Covid-19 vaccine candidate, COVIGEN, in healthy participants using the PharmaJet® needle-free devices. The vaccine will be tested in three states across Australia (NSW, SA, and WA) through Vax4COVID, an alliance of Australian vaccine clinical trial centres, formed to facilitate the conduct of clinical trials of SARS-CoV-2 vaccine candidates in Australia.
The phase 1 trial involves 150 participants to assess the safety and immunogenicity in healthy volunteers. Participants are being recruited by Scientia Clinical Research (Sydney), the Telethon Kids Institute (Perth) and the Women’s and Children’s Hospital (Adelaide). Preclinical studies confirmed the safety and immunogenicity of COVIGEN. If successful, a phase 2 trial will include a larger number of participants.
University of Sydney receives approval to start COVALIA,
a Phase 1 Clinical Trial of COVIGEN,
a New COVID-19 Vaccine Candidate in Australia
First needle-free DNA-based COVID-19 candidate vaccine to be tested in Australia in a Phase 1 trial in healthy subjects aged 18 to 75 years old
- The Lead Investigator, A/Prof Nicholas Wood at the University of Sydney Children’s Hospital Westmead Clinical School received human research ethics approval for a phase 1 trial in healthy subjects aged 18 to 75 years old.
- Patient screening and enrolment to commence in April 2021.
- Ethics approval process represents first independent review of COVIGEN pre-clinical safety and efficacy data.
Technovalia et BioNet s’associent à l'alliance Vax4COVID pour initier un essai clinique de phase 1 en Australie avec COVIGEN, un vaccin basé sur l’ADN du virus de la COVID-19
Premier vaccin à ADN contre le SRAS-CoV2 à être testé en Australie dans le cadre d'un essai de phase 1/1b sur des sujets sains âgés de 18 à 75 ans
Melbourne, le 20 septembre 2020 - Technovalia et Vax4COVID annoncent le début d'un essai prolongé de phase 1 chez l'homme en Australie, pour évaluer COVIGEN, un vaccin basé sur l’ADN du virus de la COVID-19 fabriqué par BioNet.
Technovalia partners with the Vax4COVID Alliance and BioNet to start a Phase 1 Human Vaccine Trial in Australia with COVIGEN, a COVID-19 gene-based vaccine
First SARS-CoV2 DNA vaccine to be tested in Australia in a phase 1/1b trial in healthy subjects aged 18 to 75 years old
Melbourne 20th September 2020 - Technovalia and Vax4COVID are announcing the commencement of an extended Phase 1 Human Trial in Australia evaluating COVIGEN, a COVID-19 gene-based vaccine manufactured by BioNet.