Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial

ObjectivesProtection induced by acellular vaccines can be short, requiring novel immunization strategies. Objectives of this study were to evaluate safety and capacity a recombinant pertussis toxin (PTgen) -coated Viaskin® epicutaneous patch recall memory responses in healthy adults.MethodsThis double-blind, placebo-controlled randomized trial (Phase I) assessed the immunogenicity PTgen administered on days 0 14 adults using patches applied directly or after epidermal laser-based skin preparation. Patch administration was followed Boostrix®dTpa day 42. Antibodies at 0, 14, 28, 42 70.ResultsAmong 102 volunteers enrolled, 80 received Viaskin-PT (Viaskin-PT 25 ?g (n = 25), 50 laser + 5), 25)), Viaskin-placebo 10) 2). Incidence adverse events similar across groups (any local event: 21/25 (84.0%), 24/25 (96.0%), 4/5 (80.0%), 8/10 10/12 (83.0%), respectively). Direct application no detectable response. On 42, PT-IgG geometric mean concentrations significantly higher following (139.87 (95% CI 87.30–224.10) 121.76 95.04–156.00), respectively), than (59.49, 95% 39.37–89.90). Seroresponse rates (4/5 28.4–99.5) (22/25 (88.0%), 68.8–97.5) (0/12 (0.0%), 0.0–26.5).ConclusionsViaskin-PT preparation showed encouraging results: anti-PT booster not inferior those elicited Boostrix®dTpa. This is registered ClinicalTrials.gov (NCT 03035370) funded DBV Technologies.