O Chatzis1, G Blanchard-Rohner2, L Mondoulet3, B Pelletier3, A De Gea-Hominal1, M Roux3, A Huttner4, P L Hervé3, M Rohr5, A Matthey6, G Gutknecht6, B Lemaître7, C Hayem3, H T Pham8, W Wijagkanalan8, P H Lambert1, P H Benhamou3, C A Siegrist9. 1. Centre for Vaccinology, University Hospitals of Geneva, Switzerland. 2. Centre for Vaccinology, University Hospitals of Geneva, Switzerland; Division of General Paediatrics, Department of Paediatrics, University Hospitals of Geneva, Switzerland. 3. DBV Technologies, Montrouge, France. 4. Centre for Vaccinology, University Hospitals of Geneva, Switzerland; Division of Infectious Diseases, University Hospitals of Geneva, Switzerland. 5. Division of General Paediatrics, Department of Paediatrics, University Hospitals of Geneva, Switzerland. 6. Centre for Clinical Research, University Hospitals of Geneva, Switzerland. 7. Laboratory of Vaccinology, University Hospitals of Geneva, Switzerland. 8. BioNet-Asia Co., Ltd, Bangkok, Thailand. 9. Centre for Vaccinology, University Hospitals of Geneva, Switzerland; Division of General Paediatrics, Department of Paediatrics, University Hospitals of Geneva, Switzerland. Electronic address: Claire-Anne.Siegrist@unige.ch.
Abstract
OBJECTIVES: Protection induced by acellular vaccines can be short, requiring novel immunization strategies. Objectives of this study were to evaluate safety and capacity of a recombinant pertussis toxin (PTgen) -coated Viaskin® epicutaneous patch to recall memory responses in healthy adults. METHODS: This double-blind, placebo-controlled randomized trial (Phase I) assessed the safety and immunogenicity of PTgen administered on days 0 and 14 to healthy adults usingViaskin® patches applied directly or after epidermal laser-based skin preparation. Patch administration was followed by Boostrix®dTpa on day 42. Antibodies were assessed at days 0, 14, 28, 42 and 70. RESULTS: Among 102 volunteers enrolled, 80 receivedViaskin-PT (Viaskin-PT 25 μg (n = 25), Viaskin-PT 50 μg (n = 25), laser + Viaskin-PT 25 μg (n = 5), laser + Viaskin-PT 50 μg (n = 25)), Viaskin-placebo (n = 10) or laser + Viaskin-placebo (n = 2). Incidence of adverse events was similar across groups (any local event: 21/25 (84.0%), 24/25 (96.0%), 4/5 (80.0%), 24/25 (96.0%), 8/10 (80.0%), 10/12 (83.0%), respectively). Direct application induced no detectable response. On day 42, PT-IgG geometric mean concentrations were significantly higher following laser + Viaskin-PT 25 μg and 50 μg (139.87 (95% CI 87.30-224.10) and 121.76 (95% CI 95.04-156.00), respectively), than laser + Viaskin-placebo (59.49, 95% CI 39.37-89.90). Seroresponse rates were higher following laser + Viaskin-PT 25 μg (4/5 (80.0%), 95% CI 28.4-99.5) and 50 μg (22/25 (88.0%), 95% CI 68.8-97.5) than laser + Viaskin-placebo (0/12 (0.0%), 95% CI 0.0-26.5). CONCLUSIONS:Viaskin-PT applied after laser-based epidermal skin preparation showed encouraging safety and immunogenicity results: anti-PT booster responses were not inferior to those elicited by Boostrix®dTpa. This study is registered at ClinicalTrials.gov (NCT03035370) and was funded by DBV Technologies.
RCT Entities:
OBJECTIVES: Protection induced by acellular vaccines can be short, requiring novel immunization strategies. Objectives of this study were to evaluate safety and capacity of a recombinant pertussis toxin (PTgen) -coated Viaskin® epicutaneous patch to recall memory responses in healthy adults. METHODS: This double-blind, placebo-controlled randomized trial (Phase I) assessed the safety and immunogenicity of PTgen administered on days 0 and 14 to healthy adults using Viaskin® patches applied directly or after epidermal laser-based skin preparation. Patch administration was followed by Boostrix®dTpa on day 42. Antibodies were assessed at days 0, 14, 28, 42 and 70. RESULTS: Among 102 volunteers enrolled, 80 received Viaskin-PT (Viaskin-PT 25 μg (n = 25), Viaskin-PT 50 μg (n = 25), laser + Viaskin-PT 25 μg (n = 5), laser + Viaskin-PT 50 μg (n = 25)), Viaskin-placebo (n = 10) or laser + Viaskin-placebo (n = 2). Incidence of adverse events was similar across groups (any local event: 21/25 (84.0%), 24/25 (96.0%), 4/5 (80.0%), 24/25 (96.0%), 8/10 (80.0%), 10/12 (83.0%), respectively). Direct application induced no detectable response. On day 42, PT-IgG geometric mean concentrations were significantly higher following laser + Viaskin-PT 25 μg and 50 μg (139.87 (95% CI 87.30-224.10) and 121.76 (95% CI 95.04-156.00), respectively), than laser + Viaskin-placebo (59.49, 95% CI 39.37-89.90). Seroresponse rates were higher following laser + Viaskin-PT 25 μg (4/5 (80.0%), 95% CI 28.4-99.5) and 50 μg (22/25 (88.0%), 95% CI 68.8-97.5) than laser + Viaskin-placebo (0/12 (0.0%), 95% CI 0.0-26.5). CONCLUSIONS: Viaskin-PT applied after laser-based epidermal skin preparation showed encouraging safety and immunogenicity results: anti-PT booster responses were not inferior to those elicited by Boostrix®dTpa. This study is registered at ClinicalTrials.gov (NCT03035370) and was funded by DBV Technologies.
Authors: Sandra Scheiblhofer; Stephan Drothler; Werner Braun; Reinhard Braun; Maximilian Boesch; Richard Weiss Journal: Vaccine Date: 2021-06-26 Impact factor: 4.169
Authors: Martin Bauer; Edith Lackner; Peter Matzneller; Valentin Al Jalali; Sahra Pajenda; Vincent Ling; Christof Böhler; Werner Braun; Reinhard Braun; Maximilian Boesch; Patrick M Brunner; Markus Zeitlinger Journal: Front Med (Lausanne) Date: 2021-07-16