Publications and Patents

Boosting Teenagers With Acellular Pertussis Vaccines Containing Recombinant or Chemically Inactivated Pertussis Toxin: A Randomized Clinical Trial

Boosting aP-primed adolescents with r-aP induced higher anti-PT and PT-neutralizing responses than cd/Tdap and increased PT-specific memory B cells. Despite this superior immunogenicity, r-aP may have to be given repeatedly, earlier, and/or with novel adjuvants to exert an optimal influence in aP-primed subjects.

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Epidermal micro-perforation potentiates the efficacy of epicutaneous vaccination

The skin is an immune organ comprised of a large network of antigen-presenting cells such as dendritic cells, making it an attractive target for the development of new vaccines and immunotherapies. Recently, we developed a new innovative and non-invasive vaccination method without adjuvant based on epicutaneous vaccine patches on which antigen forms a dry deposit. Here we describe in mice a method for potentiating the efficacy of our epicutaneous vaccination approach using a minimally invasive and epidermis-limited skin preparation based on laser-induced micro-perforation.

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Genetically modified pertussis toxin: a quantum leap?

Vaccines containing formalin-inactivated whole-cell Bordetella pertussis strains were first developed in the USA in the 1930s, and manufacturing processes were standardised in 1947. From the mid-1950s, whole-cell vaccines were combined with diphtheria and tetanus toxoids, but frequent systemic and local reactions and variability in effectiveness led to declining uptake in Europe and Japan. 

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Antibody persistence after vaccination of adolescents with monovalent and combined acellular pertussis vaccines containing genetically inactivated pertussis toxin: a phase 2/3 randomised, controlled, non-inferiority trial

The immunogenicity of acellular pertussis vaccines and persistence of immunity after vaccination might be improved by using genetically inactivated pertussis toxin (PTgen) instead of chemically inactivated pertussis toxin (PTchem) because of the preservation of conformational epitopes. We assessed the safety and immunogenicity of two vaccines containing PTgen 1 year after vaccination.

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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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