Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 1, 2025
Open Peer Review Period: Nov 26, 2025 - Jan 21, 2026
Date Accepted: May 27, 2026
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Protocol for the RESPONSE Study: A prospective cohort-study for the investigation of the vaccine-induced immune response after vaccination against RESPiratory viral infections in immunocompromised patients with or without hemato-ONcological diseaSEs
ABSTRACT
Background:
Respiratory virus infections, such as Coronavirus Disease 2019 (COVID-19) and influenza, remain significant international public health concerns. While patients with cancer remain the most vulnerable group, they show poor vaccine response in general. Immunologic data in this population are limited and mainly focusing on serologic parameters. However, cellular and especially T cell response seems often to be induced more reliably in those patients than humoral response.
Objective:
To gain further insights into vaccine-induced immune response, we 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 the humoral and cellular vaccine-induced immune response in pa-tients 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 with additional exploratory assays as appropriate. Immune responses will be correlated with clinical parameters, including disease status, treatment, and demographic factors.
Results:
As a pilot project, we investigated samples from patients with chronic lymphocytic leukemia (CLL; n=18) before and after influenza vaccination. Analyses of humoral and cellular vaccine-induced immunity are currently ongoing.
Conclusions:
This study intends to lay a foundation for a structured translational research program of vaccination to aim for best protection from infection by different respiratory patho-gens. 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 response to the recently approved respiratory syncytial virus (RSV) vaccine within this platform and possibly further vaccines in the future. Urging questions such as the influence of different targeted therapies on vac-cine immune response will be part of these projects. Clinical Trial: NCT06612515
Citation
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