A Phase I Clinical Study of a Live Attenuated Bordetella pertussis Vaccine - BPZE1; A Single Centre, Double-Blind, Placebo-Controlled, Dose-Escalating Study of BPZE1 Given Intranasally to Healthy Adult Male Volunteers

• Published in: PloS one Vol. 9; no. 1; p. e83449
• Main Authors: Thorstensson, Rigmor, Trollfors, Birger, Al-Tawil, Nabil, Jahnmatz, Maja, Bergström, Jakob, Ljungman, Margaretha, Törner, Anna, Wehlin, Lena, Van Broekhoven, Annie, Bosman, Fons, Debrie, Anne-Sophie, Mielcarek, Nathalie, Locht, Camille
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 08.01.2014; Public Library of Science (PLoS)
• Subjects: Administration, Intranasal; Adult; Adults; Antigens; Attenuation; Bacteria; Biology; Bordetella pertussis; Bordetella pertussis - immunology; Bordetella pertussis - isolation & purification; Clinical trials; Colonization; Colony Count, Microbial; Demography; Disease control; Dosage; Dose-Response Relationship, Immunologic; Double-Blind Method; Double-blind studies; Genetic modification; Genetically modified organisms; Healthy Volunteers; Humans; Immune response; Immunity - immunology; Immunoglobulin G - blood; Infants; Infections; Influenza; Male; Medical research; Medicine; Nasopharynx; Nasopharynx - microbiology; Nasopharynx - pathology; Optimization; Pertussis; Pertussis Vaccine - adverse effects; Pertussis Vaccine - immunology; Pertussis Vaccine - therapeutic use; Placebos; Respiratory tract; Toxins; Vaccination; Vaccines; Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; Vaccines, Attenuated - therapeutic use; Whooping cough; Whooping Cough - blood; Whooping Cough - immunology; Whooping Cough - microbiology; Whooping Cough - prevention & control; Young Adult; France; Sweden

Acellular pertussis vaccines do not control pertussis. A new approach to offer protection to infants is necessary. BPZE1, a genetically modified Bordetella pertussis strain, was developed as a live attenuated nasal pertussis vaccine by genetically eliminating or detoxifying 3 toxins. We performed a...