Publications and Patents

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

BioNet TdaP and aP vaccines are safe and induce 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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