Publications report the sustained higher antibody responses of BioNet acellular pertussis vaccines containing genetically inactivated pertussis toxin (PTgen) and the new opportunities to control the resurgence of whooping cough disease
PARIS, Dec. 17, 2018 /PRNewswire/ -- BioNet announced today that the one-year antibody persistence results from the phase 2/3 randomized controlled trial of its monovalent
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The phase 2/3 non-inferiority, randomized, controlled trial involved 450 Thai adolescents enrolled between July 6, 2015, and Aug 20, 2015. Participants received one dose of recombinant acellular pertussis vaccine containing genetically inactivated pertussis toxin (PTgen) and filamentous haemagglutinin (FHA) either in a monovalent formulation (aP) or in a combined formulation with tetanus and reduced-dose diphtheria toxoids (TdaP), or one dose of a comparator vaccine (Tdap) containing a chemically inactivated pertussis toxin (PTchem). Antibody persistence 1 year after vaccination, a secondary trial outcome, was assessed per protocol in 150 randomly preselected participants (50 per group). Seroconversion was defined as antibody titres at least four times greater than at baseline. Safety was assessed in all trial participants.
One year after vaccination seroconversion for pertussis toxin (PT) neutralizing antibodies persisted in 76% of study participants in the aP group, 81% in the TdaP group, but only 8% in the comparator group. Seroconversion rates of IgG antibodies against PT and FHA also remained higher in the aP group (82% and 64%, respectively) and in the TdaP group (75% and 56% respectively) than in the comparator group (4% and 28%, respectively).
"We are delighted to present the antibody persistence data of our recombinant acellular pertussis vaccines, Pertagen®, the only available monovalent aP vaccine and Boostagen®, the TdaP combined formulation. Both vaccines have been licensed since 2016 and offer a significant alternative to conventional vaccines against pertussis resurgence." said Pham Hong Thai, the Chief Executive Officer of BioNet.
Genetically modified pertussis toxin: a quantum leap?
In an accompanying comment, Professors Kathryn Edwards of the Vanderbilt University in Nashville, USA, and Peter McIntyre of the University of Sydney, Australia, indicate that "monovalent vaccines containing PTgen hold promises as a quantum leap forward for use in pregnant women and, potentially, neonates."
Dr Stanley Plotkin, Chairman of BioNet' Scientific Advisory Board and Emeritus Professor of the University of Pennsylvania, USA: "These comments from world-recognized pertussis experts are a strong indication of the value of PTgen in the fight against pertussis".
Dr Plotkin further added: "It is particularly important to read that after 25 years into the search for solutions to the "pertussis problem" PTgen-containing vaccines offer a significant step forward in improving population protection at the broader level. Antibody persistence is a key factor to control the resurgence of pertussis in the world, and these data are extremely encouraging for bringing these vaccines to those in need."
BioNet-Asia is an international innovative vaccine company with leadership, R&D and commercial operations in Europe, Australia and Asia. BioNet's focus is on technological innovation and global market access. The company has built global manufacturing alliances leading to the supply of billions of doses of vaccines worldwide. BioNet is also developing a broad pipeline of recombinant vaccines. Pertagen® and Boostagen®, the world's only available recombinant pertussis vaccines are manufactured in Thailand.
For further information, please contact:BioNet-Asia Co., Ltd.Mr. Laurent Dapremont Director, Strategic Business Development E-mail: email@example.com Phone: +66 (2) 361 8110 www.bionet-asia.com
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 trialLancet Infect Dis 2018; 18: 1260-68http://dx.doi.org/10.1016/S1473-3099(18)30375-X
Genetically modified pertussis toxin: a quantum leap?Lancet Infect Dis 2018; 18: 1169-71http://dx.doi.org/10.1016/S1473-3099(18)30426-2
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