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1. Staphylococcus aureus–specific skin resident memory T cells protect against bacteria colonization but exacerbate atopic dermatitis–like flares in mice

Author

Braun, Camille, Badiou, Cédric, Guironnet-Paquet, Aurélie, Iwata, Masashi, Lenief, Vanina, Mosnier, Amandine, Beauclair, Charlotte, Renucci, Emilie, Bouschon, Pauline, Cuzin, Roxane, Briend, Yoann, Patra, Vijaykumar, Patot, Sabine, Scharschmidt, Tiffany C., van Wamel, Willem, Lemmens, Nicole, Nakajima, Saeko, Vandenesh, François, Nicolas, Jean-François, Lina, Gérard, Nosbaum, Audrey, and Vocanson, Marc

Published
2024
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2. Incidence of COVID-19 mRNA vaccine symptomatic breakthrough infections during Omicron circulation in adults with or without infection prior to vaccination

Author

Durier, Christine, Ninove, Laetitia, van der Werf, Sylvie, Lefebvre, Maeva, Desaint, Corinne, Bauer, Rebecca, Attia, Mikael, Lecompte, Anne-Sophie, Lachatre, Marie, Maakaroun-Vermesse, Zoha, Nicolas, Jean-François, Verdon, Renaud, Kiladjian, Jean-Jacques, Loubet, Paul, Schmidt-Mutter, Catherine, Corbin, Violaine, Ansart, Séverine, Melica, Giovanna, Resch, Martine, Netzer, Emmanuelle, Kherabi, Yousra, Tardieu, Raphaëlle, Lelièvre, Jean-Daniel, Tartour, Eric, Meyer, Laurence, de Lamballerie, Xavier, and Launay, Odile

Published
2024
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4. Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study

Author

de Bruyn, Guy, Wang, Joyce, Purvis, Annie, Ruiz, Martin Sanchez, Adhikarla, Haritha, Alvi, Saad, Bonaparte, Matthew I., Brune, Daniel, Bueso, Agustin, Canter, Richard M., Ceregido, Maria Angeles, Deshmukh, Sachin, Diemert, David, Finn, Adam, Forrat, Remi, Fu, Bo, Gallais, Julie, Griffin, Paul, Grillet, Marie-Helene, Haney, Owen, Henderson, Jeffrey A., Koutsoukos, Marguerite, Launay, Odile, Torres, Federico Martinon, Masotti, Roger, Michael, Nelson L., Park, Juliana, Rivera-Medina, Doris Maribel, Romanyak, Natalya, Rook, Chris, Schuerman, Lode, Sher, Lawrence D., Tavares-Da-Silva, Fernanda, Whittington, Ashley, Chicz, Roman M., Gurunathan, Sanjay, Savarino, Stephen, Sridhar, Saranya, Mohammed, Allaw, Valérie, Babin, Jennifer, Babyak, Ben-Ghezala, Ines, Breuer, Thomas, Breymeier, Corinne, Conrad, Anne, Holmqvist, Ciarrah, Costa-Araujo, Cristiana, Coux, Florence, Dellanno, Christine, Dussol, Bertrand, Essink, Brandon, Garrido, Jesús, Girodet, Pierre-Olivier, Gonzalez, Claudia, Grosbois, Marie-Ange, Hammond, Justin, He, Chelsea, Homlqvist, Ciarrah, Hudzina, Kathy, Hutchens, Mark, Jackson Booth, Peta-Gay, Joaquin, Arnel, Kandasamy, Rama, Kasztejna, Jennifer, Keefer, Michael, Kimmel, Murray, Kresge, Matthew, Laine, Fabrice, Lefebvre, Maeva, Lopez, Denise, Lourdes, Malaborbor Perpetua, Maakaroun-Vermesse, Zoha, Malishchak, Caitlin, Menard, Lisa, Mendoza, Sandra, Moore, Patrick, Mulamalla, Mounika, Mulholland, Patrick, Nicolas, Jean-Francois, Ogbuagu, Onyema, Ortiz, Juan, Perroud, Ana Paula, Peyton, Gina, Purvis, Ya-Fen, Raabe, Vanessa, Rivas, Enrique, Rouphael, Nadine, Roy, Beatrice, Sagot, Lola, Sater, Nessryne, Schwartz, Howard, Severance, Randall, Shi, Jiayuan, Sobieszczyk, Magdalena, Stevens, Charlene, Thuy, Tran Phuong, Toma, Ramy, Tong, Tina, Tourneux, Sophie, Treanor, John, Turet, Núria, Froget, Rachel, Walsh, Stephen, White, Judith, del Campo Perez, Victor, Perez Breva, Lina, Rojo Conejo, Pablo, Ruiz Antoraz, Maria Belen, Chin, Toong, Fribbens, Charlotte, Phillipson, Adrian, Kaminski, Rachel, Emmett, Stevan, Hebert, Corey, Birch, Thomas, Roberson, Russell, Zacher, Jeffrey, Gelu-Maury, Sophie, Loryne, Loron, and Davis, Yvonne

Published
2023
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6. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial.

Author

Clark, Rebecca, Davies, Sam, Labrador, Jorge, Loubet, Paul, Martínez, Silvina Natalini, Moríñigo, Helena Moza, Nicolas, Jean-François, Vera, Mercè Pérez, Rämet, Mika, Rebollo-Rodrigo, Maria Henar, Sanz-Muñoz, Iván, Dezutter, Nancy, Germain, Sophie, David, Marie-Pierre, Jayadev, Amulya, Hailemariam, Hiwot Amare, Kotb, Shady, and Meyer, Nadia

Subjects
PATIENT safety, RESEARCH funding, INFLUENZA vaccines, IMMUNOGLOBULINS, STATISTICAL sampling, RESPIRATORY syncytial virus infections, RANDOMIZED controlled trials, CELLULAR immunity, DESCRIPTIVE statistics, HEMAGGLUTINATION tests, VACCINE immunogenicity, VIRAL vaccines, CONFIDENCE intervals, IMMUNOMODULATORS, OLD age
Abstract

Background We evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds. Methods This phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed. Results Overall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06–1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups. Conclusions Adjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine. Clinical Trials Registration NCT05568797 [ABSTRACT FROM AUTHOR]

Published
2024
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8. Neutralizing antibodies against SARS-CoV-2 variants following mRNA booster vaccination in adults older than 65 years

Author

Durier, Christine, Ninove, Laetitia, Lefebvre, Maeva, Radenne, Anne, Desaint, Corinne, Ropers, Jacques, Bauer, Rebecca, Lebbah, Said, Carette, Diane, Lachatre, Marie, Lecompte, Anne-Sophie, Deplanque, Dominique, Botelho-Nevers, Elisabeth, Conrad, Anne, Dussol, Bertrand, Maakaroun-Vermesse, Zoha, Melica, Giovanna, Nicolas, Jean-François, Verdon, Renaud, Kiladjian, Jacques, Loubet, Paul, Schmidt-Mutter, Catherine, Dualé, Christian, Ansart, Séverine, Priet, Stéphane, Levier, Axel, Molino, Diana, Vieillard, Louis-Victorien, Parfait, Béatrice, Lelièvre, Jean-Daniel, Tartour, Eric, de Lamballerie, Xavier, and Launay, Odile

Published
2022
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10. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial

Author

McShane, Christopher, Callendret, Benoit, Dincq, Stephanie, Ferrault, Camille, Chai, Siew Pin, Gyselen, Maire Paule, van Looveren, Marleen, van Ballert, Sylvia, de Cnodder, Tinne, Roza, Len, Forcheh, Chiara, Stevens, Kate, Mastrandrea, Carmela, de Ridder, Sanne, Gundluru, Rachana, Swales, Nathalie, Errijegers, Vanessa, Willems, Wouter, Roorda, Veronika, Orzabal, Nicola, Assenberg, Magdalena, Vialatte, Karine, Remblier, Frédéric, Porcar, Elodie, Ottavi, Anton, Destandau, Eugénie, Schwimmer, Christine, Moinot, Laetitia, Wallet, Cédrick, Allais, Florence, Savel, Hélène, Nedjaai, Naouel, Maugard, Anaïs, Lenzi, Nehza, Loulergue, Pierre, Bahuaud, Mathilde, Lainé, Fabrice, Laviolle, Bruno, Boissel, Nolwenn, Thébault, Elise, Vallée, David, Nicolas, Jean-François, Gilbert, Sophie, Dahel, Karima, Sagorny, Karen, Lucht, Frédéric, Paul, Stéphane, Haccourt Chanavat, Alice, Charra, Florent, Mutter, Catherine, Lambour, Monique, Muller, Caroline, Hutt-Clauss, Anne, Aranda, Olivia, Bernard, Louis, Gissot, Valérie, Hallouin-Bernard, Marie-Charlotte, Goudeau, Alain, Suzzoni, Steve, Auostin, Eva, Brick, Lysiane, Lopez-Zaragoza, Jose-Luis, Melic, Giovanna, Carvalho, Murial, Chesnel, Chrystel, Hocini, Hakim, Wiedemann, Aurélie, Hanot, Laurent, Rieux, Véronique, Puri, Adeep, Adeloye, Temitope, Boyce, Malcolm, Dennison, Jeremy, Loewenstein, Inge, Sahgal, Omar, van den Berg, Frans, Calvert, Wendy, Faldon, Mary, McClain, Bruce, Newell, Marie-Lousie, Molenberghs, Geert, Pollard, Andrew J, Launay, Odile, Lelievre, Jean-Daniel, Lacabaratz, Christine, Grande, Sophie, Goldstein, Neil, Robinson, Cynthia, Gaddah, Auguste, Bockstal, Viki, Wiedemann, Aurelie, Leyssen, Maarten, Luhn, Kerstin, Richert, Laura, Bétard, Christine, Gibani, Malick M, Clutterbuck, Elizabeth A, Snape, Matthew D, Levy, Yves, Douoguih, Macaya, and Thiebaut, Rodolphe

Published
2021
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14. Comprehensive Ophthalmological Evaluation in Atopic Dermatitis.

Author

Valeille, Anaïs, Ouilhon, Coralie, Subtil, Fabien, Hacard, Florence, Jaulent, Coline, Bérard, Fréderic, Nicolas, Jean-François, Fauquert, Jean-Luc, and Nosbaum, Audrey

Subjects
ALLERGIC conjunctivitis, ATOPIC dermatitis, DRY eye syndromes, ASYMPTOMATIC patients, ALLERGIC rhinitis, SKIN diseases
Abstract

Introduction: Atopic dermatitis (AD), a chronic type 2 inflammatory skin disease, is frequently associated with ocular surface diseases (OSD) which may appear or worsen under anti-type 2-targeted treatments. However, the exact prevalence of OSD and the ophthalmology referral criteria remain ill-defined in AD patients before initiating such biotherapies. We aimed to characterize the prevalence, the nature and the factors related to OSD development in AD that may justify an ophthalmological management. Methods: A total of 98 consecutive AD inpatients without biological treatment were retrospectively included. These were systematically evaluated by an ophthalmologist during their dermatological care. Clinical and laboratory data were analysed to characterize OSD and their risk factors. Results: OSD were found in 83/98 AD patients (85%); mainly dry eye syndrome (64%, 63/98), allergic conjunctivitis (42%, 41/98), posterior (33%, 32/98), and anterior blepharitis (27%, 26/98). In AD patients without ocular symptoms, OSDs were also frequently found (63%, 12/19) and were mostly mild. Risk factors for OSD were history of allergic rhinitis, allergic sensitization, head and neck AD, ocular symptoms (foreign body sensation in the eye, burning, itching, photophobia), and total IgE level >3,000 kU/L. Conclusion: The prevalence of OSD was high, even in asymptomatic patients. The risk factors identified may indicate the need for ophthalmological examination for therapeutic management, especially when biological agents targeting type 2 inflammation are considered. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Long-Term Clinical Safety of the Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: A Prospective, Multi-Country, Observational Study.

Author

Puri, Adeep, Pollard, Andrew J., Schmidt-Mutter, Catherine, Lainé, Fabrice, PrayGod, George, Kibuuka, Hannah, Barry, Houreratou, Nicolas, Jean-François, Lelièvre, Jean-Daniel, Sirima, Sodiomon Bienvenu, Kamala, Beatrice, Manno, Daniela, Watson-Jones, Deborah, Gaddah, Auguste, Keshinro, Babajide, Luhn, Kerstin, Robinson, Cynthia, and Douoguih, Macaya

Subjects
SCIENTIFIC observation, VACCINES, VACCINATION, EBOLA virus, CONFIDENCE intervals
Abstract

In this prospective, observational study (ClinicalTrials.gov Identifier: NCT02661464), long-term safety information was collected from participants previously exposed to the Ebola vaccines Ad26.ZEBOV and/or MVA-BN-Filo while enrolled in phase 1, 2, or 3 clinical studies. The study was conducted at 15 sites in seven countries (Burkina Faso, France, Kenya, Tanzania, Uganda, the United Kingdom, and the United States). Adult participants and offspring from vaccinated female participants who became pregnant (estimated conception ≤28 days after vaccination with MVA-BN-Filo or ≤3 months after vaccination with Ad26.ZEBOV) were enrolled. Adults were followed for 60 months after their first vaccination, and children born to female participants were followed for 60 months after birth. In the full analysis set (n = 614 adults; median age [range]: 32.0 [18–65] years), 49 (8.0%) had ≥1 serious adverse event (SAE); the incidence rate of any SAE was 27.4 per 1000 person-years (95% confidence interval: 21.0, 35.2). The unrelated SAEs of malaria were reported in the two infants in the full analysis set, aged 11 and 18 months; both episodes were resolved. No deaths or life-threatening SAEs occurred during the study. Overall, no major safety issues were identified; one related SAE was reported. These findings support the long-term clinical safety of the Ad26.ZEBOV and MVA-BN-Filo vaccines. [ABSTRACT FROM AUTHOR]

Published
2024
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28. Deciphering Differential Behavior of Immune Responses as the Foundation for Precision Dosing in Allergen Immunotherapy.

Author

Magnan, Antoine, Nicolas, Jean-François, Caimmi, Davide, Vocanson, Marc, Haddad, Thierry, Colas, Luc, Scurati, Silvia, Mascarell, Laurent, and Shamji, Mohamed H.

Subjects
*IMMUNE response, *B cells, *INNATE lymphoid cells, *ALLERGENS, *ALLERGIES, *T cells
Abstract

Like in many fields of medicine, the concept of precision dosing has re-emerged in routine practice in allergology. Only one retrospective study on French physicians' practice has addressed this topic so far and generated preliminary data supporting dose adaptation, mainly based on experience, patient profile understanding and response to treatment. Both intrinsic and extrinsic factors shape the individual immune system response to allergen immunotherapy (AIT). Herein, we focus on key immune cells (i.e., dendritic cells, innate lymphoid cells, B and T cells, basophils and mast cells) involved in allergic disease and its resolution to further understand the effect of AIT on the phenotype, frequency or polarization of these cells. We strive to discriminate differences in immune responses between responders and non-responders to AIT, and discuss the eligibility of a non/low-responder subset for dose adaptation. A differential behavior in immune cells is clearly observed in responders, highlighting the importance of conducting clinical trials with large cohorts of well-characterized subjects to decipher the immune mechanism of AIT. We conclude that there is a need for designing new clinical and mechanistic studies to support the scientific rationale of dose adaptation in the interest of patients who do not properly respond to AIT. [ABSTRACT FROM AUTHOR]

Published
2023
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36. Epicutaneous allergen immunotherapy induces a profound and selective modulation in skin dendritic-cell subsets.

Author

Laoubi, Léo, Lacoffrette, Morgane, Valsesia, Séverine, Lenief, Vanina, Guironnet-Paquet, Aurélie, Mosnier, Amandine, Dubois, Gwendoline, Cartier, Anna, Monti, Laurine, Marvel, Jacqueline, Espinosa, Eric, Malissen, Bernard, Henri, Sandrine, Mondoulet, Lucie, Sampson, Hugh A., Nosbaum, Audrey, Nicolas, Jean-François, Dioszeghy, Vincent, and Vocanson, Marc

Abstract

Epicutaneous immunotherapy (EPIT) protocols have recently been developed to restore tolerance in patients with food allergy. The mechanisms by which EPIT protocols promote desensitization rely on a profound immune deviation of pathogenic T- and B-cell responses. To date, little is known about the contribution of skin dendritic cells (skDCs) to T-cell remodeling and EPIT efficacy. We capitalized on a preclinical model of food allergy to ovalbumin (OVA) to characterize the phenotype and functions of OVA+ skDCs throughout the course of EPIT. Our results showed that both Langerhans cells and dermal conventional cDC1 and cDC2 subsets retained their ability to capture OVA in the skin and to migrate toward the skin-draining lymph nodes during EPIT. However, their activation/maturation status was significantly impaired, as evidenced by the gradual and selective reduction of CD86, CD40, and OVA protein expression in respective subsets. Phenotypic changes during EPIT were also characterized by a progressive diversification of single-cell gene signatures within each DC subset. Interestingly, we observed that OVA+ Langerhans cells progressively lost their capacity to prime CD4+ T EFF cells, but gained regulatory T-cell stimulatory properties. In contrast, cDC1 were inefficient in priming CD4+ T EFF cells or in reactivating T MEM cells in vitro , whereas cDC2 retained moderate stimulatory properties, and progressively biased type 2 immunity toward type 1 and type 17 responses. Our results therefore emphasize that the acquisition of distinct phenotypic and functional specializations by skDCs during EPIT is at the cornerstone of the desensitization process. [ABSTRACT FROM AUTHOR]

Published
2022
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37. Preparations of exploration of immediate hypersensitivity to antineoplastic agents: An oncology pharmacy perspective.

Author

Dubromel, Amélie, Caffin, Anne-Gaëlle, Hacard, Florence, Vantard, Nicolas, Baudouin, Amandine, Herledan, Chloé, Larbre, Virginie, Schwiertz, Vérane, Nosbaum, Audrey, Pralong, Pauline, Nicolas, Jean-François, Berard, Frédéric, Rioufol, Catherine, and Ranchon, Florence

Subjects
SKIN tests, TIME, CANCER chemotherapy, ANTINEOPLASTIC agents, PHARMACISTS' attitudes, MEDICAL care costs, MONOCLONAL antibodies, CANCER patients, COST analysis, DESCRIPTIVE statistics, DRUG allergy, PATIENT care, CANCER patient medical care, ECONOMICS, DISEASE risk factors
Abstract

Background: Cancer patients are being exposed to antineoplastic drugs more frequently and for longer periods, resulting in a higher risk of hypersensitivity reactions. The aim of this study was to assess the pharmaceutical time and direct cost of drug allergy explorations following immediate hypersensitivity reactions to antineoplastic agents. Methods: A micro-costing method was used to collect data on consumption of human and material resources for allergy exploration preparations. The monetisation was carried out on the basis of prices and hourly wage costs applied in 2018. The number and type of allergy explorations prepared by the pharmacy as well as nature of antineoplastic drugs tested, and the number of culprit drugs reintroductions were collected. Results: Almost 1.5 h is required to realise allergy tests for one patient including pharmacist time for prescription analysis and pharmacy technician's time for tests preparation. The mean manufacturing cost of these tests is estimated at €62.87 (€57.82–65.49) per culprit drug for one patient. Programming patients according to culprit drugs tested allows rationalising healthcare provider time and increasing efficiency. From January 2010 to December 2018, 277 patients were tested and 490 allergy explorations were performed, corresponding to more than 5000 preparations. Mostly, the culprit drug could be reintroduced (n = 383, 78.2%) allowing patients to receive the best possible treatment. Conclusion: Management of hypersensitivity reactions is constantly progressing, as it contributes to improving patient care in oncology. This activity is time-consuming for the pharmacy team but allows patients with previous hypersensitivity reaction to continue effective treatment. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Molecular diagnosis of skin allergy

Author

Lefevre, Marine-Alexia, Nosbaum, Audrey, Hacard, Florence, Berard, Frederic, Baeck, Marie, Herman, Anne, Bruze, Magnus, Svedman, Cecilia, Nicolas, Jean-François, and Vocanson, Marc

Published
2020
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47. Gene profiling reveals a contact allergy signature in most positive Amerchol L‐101 patch test reactions.

Author

Ljungberg Silic, Linda, Lefevre, Marine‐Alexia, Bergendorff, Ola, De Bernard, Simon, Nourikyan, Julien, Buffat, Laurent, Nosbaum, Audrey, Bruze, Magnus, Nicolas, Jean‐François, Svedman, Cecilia, and Vocanson, Marc

Subjects
ALLERGIES, GENE regulatory networks, GENETIC regulation, POLYMERASE chain reaction, SKIN inflammation, MOLECULAR diagnosis
Abstract

Background: Diagnosis of contact allergy (CA) to Amerchol L‐101 (AL‐101), a marker for lanolin allergy, is problematic. Positive patch test reactions are frequently doubtful or weakly positive and difficult to associate with clinical relevance. Objective: To gain further insight on the allergic or irritant nature of skin reactions induced by AL‐101 patch test. Methods: We re‐tested in a dose–response fashion, 10 subjects with AL‐101 CA and performed comprehensive transcriptomic analysis (gene arrays, quantitative real‐time polymerase chain reaction [qRT‐PCR]) of samples of their skin reactions. Results: Eight of the 10 CA subjects reacted positively upon re‐test, whereas two did not react. Most of AL‐101 positive patch tests expressed an allergy signature with strong activation of gene modules associated with adaptive immunity and downregulation of cornification pathway genes. In addition, the breadth of gene modulation correlated with the magnitude of patch test reactions and the concentration of AL‐101 applied. However, we observed that some of the positive patch test reactions to AL‐101 expressed no/few allergy biomarkers, suggesting the induction of an irritant skin inflammation in these samples. Conclusions: This study confirms that AL‐101 is an allergen that can cause both contact allergy and contact irritation. Our results also highlight that molecular profiling might help to strengthen clinical diagnosis. [ABSTRACT FROM AUTHOR]

Published
2022
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