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PertADO trial to evaluate Pertagen, a new recombinant pertussis vaccine in adolescents in Switzerland

Published on 23/05/2017 à 11:35

The Geneva University Hospitals in Switzerland is conducting the PertADO Geneva Trial, the first clinical study in Europe evaluating Pertagen™, a new recombinant acellular pertussis vaccine. Pertagen™ is BioNet‐Asia’s acellular pertussis vaccine containing genetically‐inactivated Pertussis Toxin (PTgen). This is the only monovalent recombinant pertussis vaccine in the world, approved in Asia for a booster indication in adolescents and adults.

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The Geneva University Hospitals (HUG) and BioNet‐Asia are announcing that they have recently completed the 28‐day safety follow‐up of the PertADO Geneva Trial, a Phase II study in Switzerland evaluating Pertagen™, a recombinant pertussis vaccine. The study aims to compare the safety and immunogenicity induced by booster vaccination with acellular pertussis vaccines including chemically or genetically‐detoxified Pertussis Toxin (PT) in adolescents previously immunized with acellular pertussis vaccines. Half of the study participants received one dose of recombinant aP vaccine plus a tetanus‐diphtheria booster vaccine, and the other half a comparator licensed Tdap vaccine containing a chemically detoxified PT. No safety issues have been reported in any of the study participants during the follow‐up period. The next step will be to measure and compare immune responses induced by the two vaccines.

Pertussis, or whooping cough, is a highly contagious respiratory illness that has been on the rise in a number of countries around the world. The disease is caused by the bacterium Bordetella pertussis whose major virulent factor is the pertussis toxin. Immunity acquired through vaccination or infection is short‐lived and requires repeated boosting at regular time points. An unprecedented global demand for pertussis vaccine has exhausted vaccine supplies in recent years. BioNet’s recombinant DNA technology produces more native and active PT than the ones included in currently available chemically detoxified acellular pertussis vaccines.

Professor Claire‐Anne Siegrist, Director of the Center of Vaccinology of HUG, and responsible for the PertADO trial said: “We are very pleased to have successfully completed the first stage of this study with the recruitment of the participants and the safety follow up. We are now keen to evaluate the immunogenicity of this recombinant acellular pertussis vaccine booster, tested for the first time 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 on this study as this is the first time that our recombinant pertussis vaccine takes part in a clinical trial in Europe. Given the safety and superior immunogenicity of Pertagen™ as demonstrated in previous trials, this study in Switzerland represents the first 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), reference academic institution at both national and international level, 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.

With their 10,500 employees, the HUG welcome each year 60,000 hospitalized patients and assure 91,000 emergencies, 990,000 consultations or ambulatory care and 26,000 surgical procedures. More than 800 physicians, 3,000 interns and 150 apprentices perform their training here. 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 phase II, randomized double‐center, and observer‐blind controlled pilot vaccine trial in 11 to 15 years old healthy subjects to assess the safety and immunogenicity of the genetically inactivated pertussis toxin included in a novel acellular pertussis vaccine manufactured by BioNet‐Asia when delivered by the intramuscular route to adolescents previously primed and boosted with chemically‐inactivated PT, along with Td vaccine and in comparison with that of a licensed Tdap vaccine. More information at ClinicalTrials.gov Identifier: NCT02946190.

About BioNet‐Asia

BioNet‐Asia Co. Ltd offers access to vaccine and technology through biotech innovation and partnering networks. BioNet has built several international partnerships fostering vaccine self‐reliance and leading to the supply of billions of doses of vaccines worldwide. BioNet has also a broad pipeline of vaccines in R&D and clinical stages. In December 2016 BioNet received Marketing Authorization Approval from the Thai Food and Drug Administration for its monovalent recombinant acellular Pertussis (aP) vaccine Pertagen™ and Tetanus‐diphtheria‐acellular Pertussis (TdaP) combination vaccine Boostagen™. BioNet’s new generation pertussis vaccines are produced from a proprietary Bordetella pertussis strain expressing genetically‐detoxified Pertussis Toxin (PTgen). The unique properties of BioNet PTgen enables the vaccine to induce superior anti‐PT immune response, as successfully demonstrated in clinical trials in adolescents and adults.

About Pertagen

Current licensed acellular pertussis vaccines are inactivated by the use of chemicals that make Pertussis Toxin (PT), the principal antigen present in all acellular pertussis vaccines, loose its natural structure. This affects the ability of vaccine induced antibodies to effectively recognize and neutralize native toxin produced at the time of infection. BioNet has patented a recombinant DNA technology to produce a genetically‐inactivated PT where the structure and PT‐neutralizing epitopes remain preserved and that elicits highly functional antibodies.

Pertagen™ is a recombinant acellular pertussis vaccine, licensed in Thailand for active booster immunization against pertussis in individuals from the age of 11 years onwards. Pertagen™ may be considered as an alternative to combined tetanus, diphtheria and acellular pertussis vaccines in persons having received multiple and frequent tetanus and diphtheria vaccine doses in the past.

Communiqué publié par Dapremont Laurent
Published on 23/05/2017 à 11:35 sur 24presse.com
Dapremont Laurent


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