ArticleJMIR research protocols2026
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.
Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06612515 (Prospective Cohort-study for the Investigation of the Vac-cine-induced Immune Response After Vaccination Against RESPiratory Viral Infections in Immunocompromised Pa-tients With or Without Haemato-ONcological diseaSEs), which is not on this map. Not yet cited in PubMed.
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Prospective Cohort-study for the Investigation of the Vac-cine-induced Immune Response After Vaccination Against RESPiratory Viral Infections in Immunocompromised Pa-tients With or Without Haemato-ONcological diseaSEs
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Abstract
backgroundInfections 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.
objectiveTo 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.
methodsHumoral 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.
resultsThis 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.
conclusionsThis 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 registrationClinicalTrials.gov NCT06612515; https://clinicaltrials.gov/study/NCT06612515. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/88520.
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