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Vaccines
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Immunogenicity, Safety, and Coverage of Vaccines in Patients with Autoimmune...
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Immunogenicity, Safety, and Coverage of Vaccines in Patients with Autoimmune Diseases

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Innate and Adaptive Immunity in Vaccination".

Deadline for manuscript submissions: 31 July 2025 | Viewed by 2063

Special Issue Editors

Dr. Andrea Picchianti-Diamanti

E-Mail Website
Guest Editor
Department of Clinical and Molecular Medicine, Sant’Andrea University Hospital, Sapienza University of Rome, 00185 Rome, Italy
Interests: biologic and targeted immunosuppressive therapy; efficacy and safety of vaccines; gut microbiota; muskoloskeletal ultrasonography
Prof. Dr. Delia Goletti

E-Mail Website
Guest Editor
1. Department of Epidemiology and Preclinical Research, National Institute for Infectious Diseases L. Spallanzani, Via Portuense 292, 00149 Roma, Italy
2. Department of Pathology, Unicamillus University, 00149 Rome, Italy
Interests: immunity to M. tuberculosis; Echinococcus granulosus; SARS-CoV-2; HIV

Special Issue Information

Dear Colleagues,

Patients with autoimmune diseases who are undergoing immunosuppressive therapy are considered vulnerable because they have a higher risk of infections compared to the general population. Serious infections in these patients are more frequent, leading to a higher mortality rate and can trigger disease reactivation. The increased risk of infection is likely due to the dysregulation of the immune system related to the disease itself and the immunodeficiency induced by immunosuppressive therapies. Common vaccinations, such as those against influenza and pneumococcus, have been proven safe and effective in these patients and are strongly recommended. On the other hand, the data supporting other vaccinations, such as VZV, HBV, and HPV, are reassuring but less robust. Additionally, information on the vaccine coverage rate in this patient population is limited. This Special Issue invites original research, systematic review, perspective, opinion, and clinical trial articles focusing on, but not limited to the following:

  • Effectiveness and safety of different vaccines in patients with autoimmune diseases;
  • Complex relationships between infections, vaccines, and autoimmune diseases;
  • Rates of vaccine coverage in patients with autoimmune diseases;
  • Impact of immunosuppressive agents on vaccine response;
  • Specific T cell response induced by vaccination.

Dr. Andrea Picchianti-Diamanti
Prof. Dr. Delia Goletti
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Vaccines is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • vaccines
  • systemic autoimmune diseases
  • bDMARDs
  • tsDMARDs
  • immunosuppressive therapy
  • adverse events
  • immunogenicity
  • coverage rates
  • specific T cell response

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Published Papers (2 papers)

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Research

18 pages, 1360 KiB  
Article
Anti-SARS-CoV-2 B and T-Cell Immune Responses Persist 12 Months After mRNA Vaccination with BNT162b2 in Systemic Lupus Erythematosus Patients Independently of Immunosuppressive Therapies
by Mario Ferraioli, Alessandra Aiello, Immacolata Prevete, Maria Sole Chimenti, Luigi De Marco, Silvia Meschi, Davide Mariotti, Valentina Vanini, Gilda Cuzzi, Andrea Salmi, Stefania Notari, Valeria Mellini, Vincenzo Puro, Fabrizio Maggi, Delia Goletti and Gian Domenico Sebastiani
Vaccines 2025, 13(4), 396; https://doi.org/10.3390/vaccines13040396 - 9 Apr 2025
Viewed by 507
Abstract
Background: In response to the SARS-CoV-2 pandemic, a massive vaccination campaign was launched. Nonetheless, concerns arose regarding some peculiar groups of patients, including those affected by Systemic Lupus Erythematosus (SLE), because of the immune-suppressive drugs routinely administered to patients and the risk of [...] Read more.
Background: In response to the SARS-CoV-2 pandemic, a massive vaccination campaign was launched. Nonetheless, concerns arose regarding some peculiar groups of patients, including those affected by Systemic Lupus Erythematosus (SLE), because of the immune-suppressive drugs routinely administered to patients and the risk of possible disease flares. Since the effects of the third booster vaccination in SLE have been poorly assessed, this study aims to evaluate the immunogenicity and safety of the third BNT162b2 vaccine dose, together with the effects of immunosuppressive drugs. Methods: A monocentric SLE cohort and a cohort of age- and sex-matched healthy controls (HCs) (all vaccinated with three homologous doses) were consecutively enrolled 6 months (T1) after their third vaccine shot. Vaccine immunogenicity was evaluated by analyzing humoral and cellular immune responses at T1 and 12 months (T2). Vaccine safety was evaluated by assessing adverse events related to vaccination (T0) and comparing disease activity among T0, T1, and T2. Effects of immunosuppressive drugs were assessed by stratifying patients according to therapy at vaccination: (1) receiving (IS) or (2) not receiving immunosuppressive drugs (Non-IS). Results: At T1, the humoral responses were comparable between SLE and HC subjects, while the cellular response was significantly higher in HC (p = 0.01). No differences were found at T2 between cohorts. Similarly, both at T1 and T2, the immune responses of IS and Non-IS groups were comparable. Moreover, lupus disease flares were limited and mostly mild, and no life-threatening adverse events were reported. Conclusions: The booster BNT162b2 vaccine is safe and induces an immune response, which is persistent and not affected by ongoing immunosuppressive drugs. Full article
(This article belongs to the Special Issue Immunogenicity, Safety, and Coverage of Vaccines in Patients with Autoimmune Diseases)
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15 pages, 892 KiB  
Article
Immunogenicity of SARS-CoV-2 Vaccination Schedules Including a Booster Dose in Patients with Systemic Lupus Erythematosus: Data from a Prospective Multicenter Study
by Natália Sarzi Sartori, Ketty Lysie Libardi Lira Machado, Samira Tatiyama Miyamoto, Flávia Zon Pretti, Maria da Penha Gomes Gouveia, Yasmin Gurtler Pinheiro de Oliveira, Vanezia Gonçalves da Silva, Filipe Faé, Ana Paula Neves Burian, Karina Rosemarie Lallemand Tapia, Anna Carolina Simões Moulin, Luiza Lorenzoni Grillo, Paula dos Santos Athayde, Helena da Silva Corona, Sabrina de Souza Ramos, Flávia Maria Matos Melo Campos Peixoto, Priscila Dias Cardoso Ribeiro, Vanessa de Oliveira Magalhães, Mariana Freitas de Aguiar, Erika Biegelmeyer, Cristiane Kayser, Alexandre Wagner Silva de Souza, Charlles Heldan de Moura Castro, Juliana Bühring, Sandra Lúcia Euzébio Ribeiro, Sérgio Henrique Oliveira dos Santos, Clara Pinheiro Martins, Jonathan Willian da Silva Rodrigues, Marcos Mavignier Sousa Dias, Bruna Guimarães Dutra, Camila Maria Paiva França Telles, Samuel Elias Basualto Dias, Rodrigo Poubel Vieira de Rezende, Katia Lino Baptista, Rodrigo Cutrim Gaudio, Ana Karla Guedes de Melo, Valéria Bezerra da Silva, Vitor Alves Cruz, Jozelia Rêgo, Rejane Maria Rodrigues de Abreu Vieira, Adah Sophia Rodrigues Vieira, Adriana Maria Kakehasi, Anna Carolina Faria Moreira Gomes Tavares, Victória Dornelas Paz Carvalho, Renata Henriques de Azevedo, Valderilio Feijó Azevedo, Olindo Assis Martins-Filho, Vanessa Peruhype-Magalhães, Andrese Aline Gasparin, Vanessa Hax, Valéria Valim, Gilda Aparecida Ferreira, Andréa Teixeira-Carvalho, Edgard Torres dos Reis-Neto, Emília Inoue Sato, Marcelo de Medeiros Pinheiro, Viviane Angelina de Souza, Ricardo Machado Xavier, Gecilmara Salviato Pileggi and Odirlei André Monticieloadd Show full author list remove Hide full author list
Vaccines 2025, 13(2), 127; https://doi.org/10.3390/vaccines13020127 - 27 Jan 2025
Cited by 1 | Viewed by 1128
Abstract
Objective: To evaluate the humoral response to and impact of SARS-CoV-2 vaccination in patients with systemic lupus erythematosus in a multicenter cohort design. Methods: Data for this analysis were obtained from the Study of Safety, Effectiveness and Duration of Immunity after Vaccination against [...] Read more.
Objective: To evaluate the humoral response to and impact of SARS-CoV-2 vaccination in patients with systemic lupus erythematosus in a multicenter cohort design. Methods: Data for this analysis were obtained from the Study of Safety, Effectiveness and Duration of Immunity after Vaccination against SARS-CoV-2 in Patients with Immune-Mediated Inflammatory Diseases (SAFER), a prospective, multicenter, phase IV, real-world study conducted across different regions of Brazil from June/2021 to March/2024. Patients aged >18 years with systemic lupus erythematosus (SLE) who received any one of the SARS-CoV-2 vaccines approved by the Brazilian health regulatory agency (CoronaVac [inactivated SARS-CoV-2 vaccine], ChAdOx-1 [AstraZeneca], or BNT162b2 [Pfizer-BioNTech]) were included. Immunogenicity was assessed in pre- and post-vaccination blood samples, and patients were monitored in person and remotely for the occurrence and severity of COVID-19. Results: Two hundred and thirty-five patients with SLE who had completed their vaccination schedules (two doses + booster dose) were included in this study. Most patients were female (89.3%) and had low disease activity or were in remission (72.4%); the majority were also on some form of immunosuppressive therapy (58.1%). One hundred and sixteen patients received two doses of CoronaVac followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, eighty-seven received two doses of ChAdOx1-S (AstraZeneca) followed by one dose of BNT162b2 (Pfizer-BioNTech) vaccine, and thirty-two received three doses of BNT162b2 (Pfizer-BioNTech) vaccine. Twenty-eight cases of COVID-19, none meeting criteria for severe COVID-19, were recorded in patients with respiratory symptoms after the second dose of a SARS-CoV-2 vaccine. Regarding immunogenicity, an increase in seroconversion rate was observed following consecutive vaccine doses, with no difference between vaccination schedules, reaching 97.57% seropositivity after a booster dose. The geometric mean IgG titers differed between the different vaccination schedules after the first and the second vaccine dose, being lowest for the CoronaVac-based schedule, but titers were similar after the administration of a booster dose. Conclusion: In patients with SLE, SARS-CoV-2 vaccines are immunogenic, inducing a robust humoral response. No severe outcomes associated with death or hospitalization were found in the evaluated patient sample. Complete vaccination schedules including a booster dose induced higher humoral responses than incomplete schedules, especially in patients initially immunized with an inactivated virus vaccine schedule and those with a suboptimal humoral response. Full article
(This article belongs to the Special Issue Immunogenicity, Safety, and Coverage of Vaccines in Patients with Autoimmune Diseases)
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