Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial
| Autor: | M. Rohr, M. Roux, A. De Gea-Hominal, G. Blanchard-Rohner, P.H. Lambert, W. Wijagkanalan, Pierre-Henri Benhamou, P.L. Hervé, Benjamin Pelletier, Angela Huttner, H.T. Pham, A. Matthey, G. Gutknecht, Claire-Anne Siegrist, Lucie Mondoulet, C. Hayem, O. Chatzis, B. Lemaître |
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| Přispěvatelé: | UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de pédiatrie générale |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Male Placebo-controlled study Gastroenterology law.invention Pertussis vaccine 0302 clinical medicine Randomized controlled trial law Pregnancy Seroepidemiologic Studies Medicine 030212 general & internal medicine Recombined pertussis toxin ddc:616 ddc:618 biology Immunogenicity Incidence (epidemiology) Antibodies Bacterial/blood General Medicine Antibodies Bacterial Needleless vaccine Meningococcal Vaccines/administration & dosage/immunology Vaccination Infectious Diseases B-Lymphocytes/chemistry/immunology Female Antibody Randomized trial medicine.drug Microbiology (medical) Neisseria meningitidis/immunology Adult medicine.medical_specialty Adolescent 030106 microbiology Enzyme-Linked Immunosorbent Assay Administration Cutaneous Epicutaneous vaccination 03 medical and health sciences Young Adult Double-Blind Method Internal medicine Placenta/metabolism Humans Vaccination/methods Immune response Adverse effect business.industry Infant United Kingdom Pertussis Toxin Immunoglobulin G biology.protein business Immunity Maternally-Acquired Immunologic Memory |
| Zdroj: | Clinical microbiology and infection, Vol. 27, no. 6, p. 878-885 (2021) Clinical Microbiology and Infection, Vol. 32, No 7 (2020) pp. 768-776 |
| ISSN: | 1198-743X |
| Popis: | 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 (NCT 03035370) and was funded by DBV Technologies. |
| Databáze: | OpenAIRE |
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