Publications and Patents

BioNet announces the results of pivotal study evaluating Boostagen and Pertagen are published in the Lancet Infectious Diseases.

The new TdaP(PTgen/FHA) vaccine is safe and induces higher pertussis responses 28 days after vaccination than does the available licensed Tdap booster vaccine. Results of our trial led to the licensure of new acellular pertussis vaccines containing genetically inactivated pertussis toxin in Thailand. The availability of recombinant monovalent pertussis vaccines that induce high antibody responses provides the medical community and consumers with the opportunity to vaccinate against pertussis when immunisation against diphtheria and tetanus is not required or not desired. Studies are underway to pave the way for licensure studies of this acellular pertussis vaccine in other countries.

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BioNet-Asia announces the publication of the article “Safety and immunogenicity of a combined Tetanus, Diphtheria, recombinant acellular Pertussis vaccine (TdaP) in healthy Thai adults” in Human Vaccines & Immunotherapeutics, Issue 1, 2017.

This article presents the results of the first clinical study of BioNet-Asia’s acellular Pertussis (aP) vaccine containing recombinant genetically detoxified Pertussis Toxin (PTgenTM), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) in a phase I/II, observer-blind, randomized controlled trial in 60 healthy adult volunteers aged 18–35 y.

In this clinical study, PTgen-based BioNet’s aP and TdaP vaccines showed a similar tolerability and safety profile to the comparator and elicited significantly higher immune responses to PT and FHA.

“The high immunogenicity of PTgen was demonstrated in a clinical study for the first time in adults and is consistent with previous studies that demonstrated high and sustained efficacy of rPT-containing aP vaccines in infants” indicated Dr Simonetta Viviani, Director Clinical Development.

To read the full article, click link.

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Needle-free and adjuvant-free epicutaneous boosting of pertussis immunity: Preclinical proof of concept (2015)

The limited durability of pertussis vaccine-induced protection requires novel approaches to reactivate
immunity and limit pertussis resurgence in older children and adults. We propose that periodic boosters
could be delivered using a novel epicutaneous delivery system (Viaskin) to deliver optimized pertussis
antigens such as genetically-detoxified pertussis toxin (rPT). To best mimic the human situation in which
vaccine-induced memory cells persist, whereas antibodies wane, we developed a novel adoptive transfer
murine model of pertussis immunity. This allowed demonstrating that a single application of Viaskin
delivering rPT and/or pertactin and filamentous hemagglutinin effectively reactivates vaccine-induced
pertussis immunity and protects against Bordetella pertussis challenge. Recalling pertussis immunity
without needles nor adjuvant may considerably facilitate the acceptance and application of periodic
boosters.

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Construction of Bordetella pertussis strains with enhanced production of genetically-inactivated Pertussis Toxin and Pertactin by unmarked allelic exchange (2012)

Acellular Pertussis vaccines against whooping cough caused by Bordetella pertussis present a much-improved safety profile compared to the original vaccine of killed whole cells. The principal antigen of acellular Pertussis vaccine, Pertussis Toxin (PT), must be chemically inactivated to obtain the corresponding toxoid (PTd). This process, however, results in extensive denaturation of the antigen. The development of acellular Pertussis vaccines containing PTd or recombinant PT (rPT) with inactivated S1, Filamentous Hemagglutinin (FHA), and Pertactin (PRN) has shown that the yield of PRN was limiting, whereas FHA was overproduced. To improve antigen yields and process economics, we have constructed strains of Bordetella pertussis that produce enhanced levels of both rPT and PRN.

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BioNet has filed a patent application for its Recombinant Acellular Pertussis Vaccine (2012)