The Geneva University Hospitals has conducted the PertADO Trial, the first clinical study in Europe evaluating Pertagen, a new recombinant acellular pertussis vaccine. BioNet’s Pertagen is the only monovalent recombinant pertussis vaccine in the world approved in Asia for a booster indication in adolescents and adults.
GENEVA, 30 August, 2017 – The Geneva University Hospitals (HUG) and BioNet-Asia (BioNet) are announcing that results of the PertADO Trial in Switzerland show that vaccination of adolescents with Pertagen, a new recombinant pertussis vaccine developed by BioNet, induced a higher Pertussis Toxin (PT) response 28 days after immunization than vaccination with a licensed comparator vaccine.
Sixty healthy 11-15 years old Swiss volunteers, who had been immunized with five doses of a cellular pertussis (aP) vaccine in earlier childhood, were vaccinated either with one dose of the new Pertagen recombinant aP vaccine containing genetically-detoxified PT, or one dose of a comparator licensed Tdap vaccine containing a chemically detoxified PT. PT-antibody responses were assessed 28 days after vaccination and were found to be significantly higher in the group vaccinated with Pertagen. No safety issues were reported in any of the study participants during the follow-up period.
Professor Claire-Anne Siegrist, Director of the Center of Vaccinology of HUG, and responsible for the PertADO trial said: “We are excited by the positive results showing that immune responses induced by this recombinant acellular pertussis vaccine booster are higher one month after vaccination compared to the licensed vaccine. It is the first time that this new pertussis vaccine is tested in adolescents previously immunized with five doses of conventional acellular pertussis vaccines. A monovalent recombinant pertussis vaccine, not formulated with other antigens, could represent a very interesting alternative solution to conventional Tdap vaccines when only boosting pertussis immunity is sought or needed.”
Dr. Pham Hong Thai, Chief Executive Officer of BioNet-Asia, said: “We are delighted to collaborate with the Geneva University Hospitals. This new study confirms the safety and high immunogenicity of Pertagen which were demonstrated in previous trials in Asia. This is a significant step towards bringing a novel acellular pertussis vaccine to Europe to address waning immunity and pertussis resurgence.”
About Geneva University Hospitals and the PertADO trial
The Geneva University Hospitals (HUG) gather eight public hospitals of Geneva. Its Center of Vaccinology, led by Professor Claire-Anne Siegrist, gained international recognition through the performance of a large first-in-humans Phase I randomized clinical trial that enrolled 115 subjects to characterize the safety and immunogenicity of the VSV-ZEBOV Ebola vaccine candidate. The HUG are working closely with the Faculty of Medicine of the University of Geneva and WHO in various training and research projects. They develop partnerships with CHUV, EPFL, CERN and other actors from the Lemanic Health Valley. More information on: www.hug-ge.ch
The PertADO Geneva Trial is a randomized double-center, and observer-blind controlled pilot Phase II study aimed at comparing the safety and immunogenicity induced by booster vaccination with acellular pertussis vaccines including chemically detoxified or recombinant PT in adolescents previously immunized with acellular pertussis vaccines.? More information at ClinicalTrials.gov Identifier: NCT02946190.
About BioNet and Pertagen
BioNet-Asia offers access to vaccine and technology through biotech innovation and partnering networks. In 2016 BioNet received Marketing Authorization Approval from the Thai FDA for the world’s only recombinant acellular pertussis (aP) vaccines, a monovalent aP vaccine Pertagen and a combined TdaP vaccine Boostagen.
BioNet’s new generation pertussis vaccines are produced from a proprietary strain expressing a Pertussis Toxin genetically-detoxified (PTgen) with preserved neutralizing epitopes.
HUG Media Contact
Nicolas de Saussure, PR Officer
+41(22)?372?60?06
nicolas.desaussure@hcuge.ch
BioNet Contact
Laurent Dapremont, Director Strategic Business Development
+66 (2) 361 8110
laurent.d@bionet-asia.com
www.bionet-asia.com
+66 (2) 361 8110
laurent.d@bionet-asia.com
www.bionet-asia.com
