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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 mgIncidence 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 þ Viaskin-PT 25 mg and 50 mg (139.87 (95% CI 87.30e224.10) and 121.76 (95% CI 95.04e156.00), respectively), than laser þ Viaskin-placebo (59.49, 95% CI 39.37e89.90). Seroresponse rates were higher following laser þ Viaskin-PT 25 mg (4/5 (80.0%), 95% CI 28.4e99.5) and 50 mg (22/25 (88.0%), 95% CI 68.8e97.5) than laser þ Viaskin-placebo (0/12 (0.0%), 95% CI 0.0e26.5). 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 Boos-trix®dTpa. This study is registered at ClinicalTrials.gov (NCT 03035370) and was funded by DBV Technologies.

Little is known on the long-lasting humoral response and the T cell activation induced by SARS-COV2 mRNA vaccines in patients with cancer. The study assessed the efficacy of the SARS-COV2 mRNA vaccines through measuring the seroconversion rate at pre-specified time points and the effect on the T cell immunity in patients with cancers. The study included 131 adult patients with solid or haematological cancer, who received SARS-COV2 mRNA vaccines. 96.2% of them exhibited adequate antibody response to the SARS-COV2 mRNA vaccines 2 months after the booster dose. SARS-COV2 mRNA vaccines could induce T cell activation, however this is more likely in patients who have a positive seroconversion (94%) compared to the patients who did not (50%). Further research into the clinical relevance of low antibodies titers and lack of T cell activity is required to set up an effective vaccination strategy within this group of patients.