JMIR research protocols · 2026
Investigation of Vaccine-Induced Immune Response After Vaccination Against Respiratory Viruses in Immunocompromised Patients With or Without Hemato-Oncological Diseases (RESPONSE): Protocol for a Prospective Cohort Study.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Felipe Fumero Eloísa, Stemler Jannik, Sprute Rosanne, Sauer Katja M, Gruell Henning, Kreer Christoph, Klein Florian, Theobald Sebastian J, Rybniker Jan, Cornely Oliver A, Kappes Lara, Cremer Louise M, Mellinghoff Sibylle C
Аннотация
BACKGROUND: Infections with respiratory viruses such as SARS-CoV-2 and influenza are significant international public health concerns. While patients with cancer remain the most vulnerable group, they show poor vaccine response in general. Immunological data in this population are limited and mainly focus on serological parameters. However, in these patients, cellular, and especially T-cell, responses often seem to be induced more reliably than humoral responses.
OBJECTIVE: To gain further insights into vaccine-induced immunity, the RESPONSE study will analyze the effect of early and late booster vaccination on humoral and cellular responses, with special focus on T cell-induced immune responses. In addition, we aim to investigate factors influencing humoral and cellular vaccine-induced immunity in patients with hematological and oncological malignancies, including state of disease, treatment, and demographic factors.
METHODS: Humoral immune responses will be assessed by measuring binding and neutralizing antibodies using standardized assays. Cellular immunity will be evaluated using functional assays such as flow cytometry and FluoroSpot, as well as in-depth analyses using additional exploratory assays as appropriate. Immune responses will be correlated with clinical parameters, including disease status, treatment, and demographic factors.
RESULTS: This study was initiated following ethics approval and is currently recruiting participants. Enrollment commenced on March 25, 2025, and is ongoing, whereas biosample collection and follow-up visits are nearing completion for most participants. Final data cleaning, dataset integration, and statistical analyses of adaptive immune responses are planned from the third quarter of 2026 onward.
CONCLUSIONS: This study intends to lay a foundation for a structured translational research platform on vaccination to aim for best protection from infection by different respiratory pathogens. Long-term objectives are reaching best possible protection from vaccine-preventable disease with a first focus on influenza infection. In addition, we plan to investigate vaccine-induced immune responses to the recently approved respiratory syncytial virus vaccine using this platform and possibly extend this to further vaccines in the future. Urgent questions, such as the influence of different targeted therapies on vaccine immune response, will be part of these projects.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06612515; https://clinicaltrials.gov/study/NCT06612515.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/88520.
OBJECTIVE: To gain further insights into vaccine-induced immunity, the RESPONSE study will analyze the effect of early and late booster vaccination on humoral and cellular responses, with special focus on T cell-induced immune responses. In addition, we aim to investigate factors influencing humoral and cellular vaccine-induced immunity in patients with hematological and oncological malignancies, including state of disease, treatment, and demographic factors.
METHODS: Humoral immune responses will be assessed by measuring binding and neutralizing antibodies using standardized assays. Cellular immunity will be evaluated using functional assays such as flow cytometry and FluoroSpot, as well as in-depth analyses using additional exploratory assays as appropriate. Immune responses will be correlated with clinical parameters, including disease status, treatment, and demographic factors.
RESULTS: This study was initiated following ethics approval and is currently recruiting participants. Enrollment commenced on March 25, 2025, and is ongoing, whereas biosample collection and follow-up visits are nearing completion for most participants. Final data cleaning, dataset integration, and statistical analyses of adaptive immune responses are planned from the third quarter of 2026 onward.
CONCLUSIONS: This study intends to lay a foundation for a structured translational research platform on vaccination to aim for best protection from infection by different respiratory pathogens. Long-term objectives are reaching best possible protection from vaccine-preventable disease with a first focus on influenza infection. In addition, we plan to investigate vaccine-induced immune responses to the recently approved respiratory syncytial virus vaccine using this platform and possibly extend this to further vaccines in the future. Urgent questions, such as the influence of different targeted therapies on vaccine immune response, will be part of these projects.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06612515; https://clinicaltrials.gov/study/NCT06612515.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/88520.