Immunogenicity and reactogenicity of the adjuvanted respiratory syncytial virus vaccine in patients with chronic kidney disease

Richard Radun; Saskia Bronder; Amina Abu-Omar; Danilo Fliser; Martina Sester; David Schmit

doi:10.1093/ckj/sfag093

. 2026 Mar 24;19(5):sfag093. doi: 10.1093/ckj/sfag093

Immunogenicity and reactogenicity of the adjuvanted respiratory syncytial virus vaccine in patients with chronic kidney disease

Richard Radun ^1,^#, Saskia Bronder ^2,^#, Amina Abu-Omar ³, Danilo Fliser ⁴, Martina Sester ^5,^6,^✉, David Schmit ^7,^✉

PMCID: PMC13146607 PMID: 42100713

ABSTRACT

Background

Chronic kidney disease (CKD) contributes to global mortality and morbidity, also due to infectious complications resulting from immune system dysregulation. Recently, respiratory syncytial virus (RSV) vaccines based on the prefusion F (preF) glycoprotein have been licensed for prevention of severe disease in elderly and in patients with comorbidities, but data on immunogenicity in patients with CKD are scarce.

Methods

We characterized humoral and cellular immunogenicity of 75 patients with CKD stages G3a to G5d both before and 14 days (IQR 2) after vaccination with an adjuvanted protein-based RSVpreF3-vaccine using ELISA and flow cytometry. Data on adverse events were collected through a self-reported questionnaire.

Results

Vaccination led to a significant induction of RSV-specific CD4 T cells (P < .0001) and the increase did not differ between the CKD stages. CD8 T cells were not specifically induced. Despite high seroprevalence prior to vaccination, quantitative levels of RSV-specific immunoglobulins IgG and F protein-specific IgG were significantly induced on vaccination (both P < .0001), with a less pronounced increase in patients with advanced CKD. Urinary albumin-creatinine-ratio (UACR) was shown to be predictive of vaccine response in a multivariate regression model using age, serum creatinine and urea as covariates (P = .035). The vaccine was well tolerated with mostly transient adverse events at the injection site.

Conclusions

RSV-vaccination led to a robust CD4 T-cell and humoral response in patients with CKD with less pronounced effects in those with high-grade proteinuria. Long-term data on immunogenicity and correlation with clinical outcomes are warranted to define optimal vaccination strategies.

Keywords: chronic kidney disease, immunoglobulins, respiratory syncytial virus, RSVpreF3-vaccination, T cells

GRAPHICAL ABSTRACT

For image description, please refer to the figure legend and surrounding text.

KEY LEARNING POINTS.

What was known:

There are limited data on RSV-vaccine immunogenicity in patients with CKD, despite them being a high-risk group for developing severe RSV-associated lower respiratory tract infection.

This study adds:

Administration of the AS01_E-adjuvanted RSVpreF3-vaccine significantly induces RSV-specific IgG and CD4 T cells in patients with CKD, including those on hemodialysis and under medical immunosuppression.
Humoral vaccine response is reduced in advanced CKD and inversely correlates with UACR.

Potential impact:

RSV-vaccination is safe and immunogenic in patients with CKD, supporting the integration of RSV-vaccination into routine preventive care for the CKD population.

INTRODUCTION

Respiratory syncytial virus (RSV) infection poses a major risk for developing virus-associated lower respiratory tract infections. In particular, high-risk groups including elderly and chronically ill individuals such as patients with chronic kidney disease (CKD) show high rates of RSV-associated complications with a global annual estimate of >5 million hospitalizations and 100 000 deaths worldwide [1]. Recently, RSV-vaccination strategies using protein-based or mRNA-based vaccine platforms have been licensed for elderly and individuals with comorbidities including patients with CKD [2]. Two international, randomized, placebo-controlled phase III trials using an AS01_E-adjuvanted RSVpreF3-vaccine and the bivalent non-adjuvanted RSVpreF-vaccine have shown high vaccine efficacy of 94.1% and 85.7%, respectively, in preventing severe RSV-associated lower respiratory tract infection over the course of one RSV season in patients >60 years of age without relevant safety concerns [3, 4].

CKD affects ∼10% of the global population [5] and entails various facets of immunodeficiency. Innate and adaptive immunity are known to be impaired in uremia, and hemodialysis treatment as well as medical maintenance immunosuppression may further alter immune cell phenotype, antigen presentation and cytokine response. Reduced vaccine responsiveness in patients with CKD has been demonstrated for influenza, hepatitis B, and pneumococcal vaccines [6–11], where patients with advanced CKD and those receiving dialysis mount weaker and shorter-lived immune responses compared to the general population [12]. Despite the recent surge in RSV-vaccine research, there are limited data on immunogenicity and reactogenicity of RSV-vaccination in patients with CKD.

We therefore explored the cellular and humoral immunogenicity of RSV-vaccination in patients with CKD KDIGO stages G3–G5. A subset of patients received maintenance immunosuppression or intermittent hemodialysis treatment. To this end, we characterized the early vaccine-induced RSV-specific T cells and immunoglobulins in 75 patients with various CKD etiologies before and after receiving the AS01_E-adjuvanted RSVpreF3-vaccine and assessed reactogenicity using a self-reported standardized questionnaire in this prospective cohort study.

MATERIALS AND METHODS

Study design and subjects

From January 2025 to May 2025, patients with CKD (KDIGO stages G3a to G5d) were prospectively enrolled at the Saarland University Medical Center in Homburg, Germany. All patients received a single dose of the protein-based AS01_E-adjuvanted vaccine RSVPreF3 (“Arexvy,” GSK) intramuscularly according to national vaccination recommendations. Further details on collected demographic and clinical data and routine laboratory parameters are given in the Supplementary Methods. The study was performed in adherence with the declaration of Helsinki and approved by the ethics committee of the Saarland Medical Association (reference 99/24), and written informed consent was obtained from all individuals.

Quantification and characterization of RSV-specific CD4 and CD8 T cells

RSV-specific CD4 and CD8 T cells were quantified and characterized using flow cytometry after a 6-hour stimulation of heparinized whole-blood samples as previously described [13, 14]. A detailed description of the procedure can be found in the Supplementary Methods including antibodies used for staining (Table S1), and a gating strategy for flow-cytometric analyses (Fig. S1).

Determination of RSV-specific antibodies

Specific IgG and IgA antibodies toward pan-RSV and RSV-F (fusion protein) specific IgG were measured as described in the Supplementary Methods.

Statistical analysis

All statistical analyses were performed using GraphPad Prism v.10.6 software (GraphPad, San Diego. CA, USA). Statistical comparisons were conducted using nonparametric tests in case of nonnormality of data. The Mann–Whitney U-test was applied for comparisons between two independent groups, while comparisons of more than two unpaired groups were performed using the Kruskal–Wallis H test followed by Dunn’s post hoc test in case of reaching significance. For paired nonparametric data, the Wilcoxon signed-rank test was employed. Linear correlations between immunological and clinical data were assessed using Spearman’s rank correlation coefficient, and multivariate logistic regression analysis was performed using R v.4.5.1 software to determine predictors of immunogenicity. Owing to the lack of predefined clinically relevant cutoffs, a composite vaccine response encompassing both RSV-specific CD4 T cells and IgG antibodies was defined in this study as any measurable rise from baseline. Parametric data were analyzed with an unpaired t-test, whereas nominal and dichotomous variables were compared using the chi-squared test. A two-sided significance level of P < .05 was considered statistically significant.

RESULTS

Study population

In this observational study, 75 patients with CKD were recruited with 17 to 21 patients in each CKD stage from G3a to G5d. Fifteen out of 19 patients within the CKD G5 cohort were on intermittent maintenance hemodialysis. Relevant demographic and clinical features including kidney disease, comorbidities, immunosuppression, laboratory parameters, and differential blood counts are shown in Table 1. The mean age of all patients was 74.7 years with no significant differences between groups and sex distribution was comparable across all groups. The median interval between vaccination and follow-up visit was 14 (IQR 2) days and did not differ between groups. There were no significant differences in the automated differential blood counts with regards to total leukocyte number among the patients except for a non-significant trend toward a higher number of monocytes in patients with CKD G5/G5d. Serum levels of creatinine, urea, and intact parathyroid hormone and UACR increased progressively with more advanced CKD. Conversely, hemoglobin levels and estimated glomerular filtration rate (eGFR) decreased. Eleven patients received B-cell or plasma cell-depleting therapy within the past 6 months (e.g. rituximab), ongoing treatment with calcineurin inhibitors, antimetabolites, glucocorticoids, or complement inhibitors. The prevalence of diabetes mellitus was similar in all groups whereas an autoimmune disease affecting the kidneys was more frequent in the group with advanced CKD. These included vasculitis, IgA nephropathy, membranous, or immune complex glomerulonephritis as well as renal amyloidosis.

Table 1:

Clinical and demographic data on CKD study patients.

	Overall	G3a	G3b	G4	G5/G5d
	n = 75	n = 18	n = 21	n = 17	n = 19 (HD = 15)
Years of age, mean (SD)	74.7 (7.2)	72.1 (6.0)	73.7 (6.7)	76.7 (8.5)	76.3 (7.0)
Days between vaccination and follow-up measurement, median (IQR)	14 (2)	15 (4.5)	14 (1.5)	14 (1)	14 (5)
Sex, n (%)
Female	32 (42.7)	9 (50)	7 (33.3)	6 (35.3)	9 (47.4)
Male	43 (57.3)	9 (50)	14 (66.7)	11(64.7)	10 (52.6)
Differential blood count, median (IQR) cells/µl
Leukocytes	7600 (2600)	7550 (2500)	7200 (2500)	7500 (2200)	8200 (2600)
Granulocytes	5034 (2018)	4858 (1596)	4874 (1966)	5120 (2065)	5141 (2388)
Monocytes	676 (276)	720 (425)	640 (302)	646 (245)	770 (280)
Lymphocytes	1689 (730)	1866 (973)	1685 (504)	1550 (622)	1581 (676)
Hemoglobin, median (IQR), g/dl	12.9 (2.7)	13.5 (2.1)	14.1 (2.2)	12.8 (1.4)	11.4 (1.2)
Diabetes mellitus, n (%)	29 (38.7)	6 (33.3)	11 (52.4)	8 (47.1)	4 (21.1)
Renal autoimmune disease, n (%)	26 (34.7)	6 (33.3)	3 (14.3)	11 (64.7)	6 (31.6)
Immunosuppressive medication, n (%)	11 (14.7)	2 (11.1)	2 (9.5)	4 (23.5)	3 (15.8)
Serum urea, median (IQR) mg/dl	74 (55.5)	45.5 (20)	58 (26)	107 (24)	115 (55.5)
Serum creatinine, median (IQR) mg/dl	1.94 (1.63)	1.22 (0.15)	1.59 (0.31)	2.31 (0.75)	5.42 (3.28)
Creatinine-derived eGFR, median (IQR) ml/min/1.73 m²	30.8 (26.9)	51.7 (13.7)	36.6 (8.5)	24.3 (7.7)	7.1 (5.4)
Urine albumin–creatinine ratio, median (IQR) mg/g	142.2 (379.5)	26.3 (257.2)	52.7 (340.6)	137.1 (180.6)	289.2 (744.4)
Serum parathyroid hormone, median (IQR) pg/ml	88 (72)	47.5 (23.5)	74 (46)	93 (43)	161 (195)

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Abbreviations: HD, hemodialysis; IQR, interquartile range; SD, standard deviation.

Vaccine-induced humoral and cellular immunity in patients with CKD

For characterization of humoral immunogenicity of the RSVPreF3-AS01_E-vaccine, RSV-specific IgG, IgA and F-IgG antibodies were measured. After a median follow-up of 14 days postvaccination, median pan-RSV-specific IgG levels showed a significant increase from 110 (IQR 41) RU/ml to 128 (IQR 32) RU/ml (P < .0001, geometric mean 1.21-fold Fig. 1a). Seropositivity defined as the percentage of individuals with an IgG level above 18 RU/ml was high with 100% before and after vaccination (Fig. 1a). Likewise, vaccine RSV-F protein-specific IgG antibodies were detectable already before vaccination, and showed a significant increase from 152 (IQR 198) U/ml to 1305 (IQR 2669) U/ml (5.99-fold, P < .0001). Pan-RSV-specific IgA levels were measured in a subgroup of patients. Despite low overall levels IgA levels showed a significant induction (1.51-fold, P = .030, Fig. 1a).

RSV-specific CD4 and CD8 T cells were quantified based on induction of interferon gamma (IFNγ) after stimulation with RSV-derived peptides. On vaccination, a significant increase in the percentage of RSV-specific activated CD4 T cells was observed (P < .0001, Fig. 1b). Before vaccination, 50% of patients showed RSV-specific CD4 T cells above the detection limit with an increase to 96% after vaccination (Fig. 1b). CD8 T cells showed higher variability at baseline and were not significantly induced upon vaccination (Fig. 1b). A pronounced CD4 and CD8 T-cell response was detected after polyclonal stimulation with Staphylococcus aureus enterotoxin B (SEB), which was largely unaffected by RSV-vaccination.

Differentiation of groups according to their clinical CKD stages revealed significant differences with highest geometric mean increases in pan-RSV-specific IgG titers in the G3a patient group with a 1.36-fold induction. In stages G3b, G4, and G5 the increases were 1.23-fold, 1.18-fold, and 1.08-fold, respectively (P = .024). Similarly, there was a numerical decline in RSV-specific CD4 T cells with higher CKD stages without reaching statistical significance (P = .819, Fig. 1c).

Functional and phenotypical characterization of RSV-specific T cells

RSV-specific CD4 and CD8 T cells were further characterized for their capacity to produce the cytokines TNF and IL-2. As with T cells producing IFNγ, the percentage of CD69⁺ CD4 T cells producing TNF and IL-2 also showed a significant induction after vaccination, whereas respective CD8 T-cell populations were not induced (Fig. S2a). Among vaccine-induced RSV-specific CD4 T cells, most cells (54.9%) were polyfunctional with the capability to produce all three cytokines simultaneously, while 31.5% were dual-cytokine positive, and 13.6% of cells produced one cytokine only (Fig. S2b). This pattern was distinct from that of polyclonally stimulated T cells, where 19.5% of cells were triple positive and similar fractions produced two cytokines (43.5%) or one cytokine (37.0%). As a sign for recent antigen encounter, numerical expansion of RSV-specific CD4 T cells after vaccination was associated with a significant upregulation of CTLA-4 as compared to prevaccination levels (P < .0001). CTLA-4 expression on CD4 T cells after polyclonal stimulation was low and was unaffected by the vaccine (P = .304, Fig. S2c).

Immunogenicity in CKD subgroups

We further assessed RSV-vaccine immunogenicity among CKD subgroups in exploratory analyses, where 15 patients on intermittent hemodialysis were compared with non-dialysis patients (Fig. 2a). Baseline levels of pan-RSV-specific IgG were higher in dialysis patients (P = .007). Levels increased significantly in both groups, but to a lesser extent in patients on hemodialysis than in non-dialysis patients (P < .018). By contrast, baseline levels of RSV-F-specific IgG were lower in patients on dialysis, and were robustly induced in both groups without significant differences in patients with and without dialysis (P = .469). Patients on dialysis had a higher proportion of RSV-specific CD4 T cells above detection limit at baseline (P = .034), which increased to a similar extent as in non-dialysis patients P = .330, Fig. 2a).

When comparing a subset of 11 patients with CKD receiving maintenance immunosuppressive therapy with patients without immunosuppression, both subgroups showed a significant increase in IgG antibodies (pan-RSV, F-specific) and RSV-specific CD4 T cells. However, there was no difference in the extent of increase between the groups (Fig. 2b). Finally, patients with CKD were stratified into an advanced disease cohort (eGFR <30 ml/min/1.73 m², >G4) and less advanced cohort (G3a/b). In both groups, RSV-specific IgG were robustly induced on vaccination with a less pronounced increase in advanced CKD (P = .030, Fig. S3). Similarly, a significant induction of RSV-F-specific IgG and RSV-specific CD4 T cells was observed in both groups, but the extent of increase did not differ between the groups (Fig. S3).

Clinical correlations and predictors of immune response

Standardized clinical parameters associated with CKD and its progression were collected and analyzed in terms of their correlation with cellular and humoral immunogenicity. A moderate but significant inverse linear correlation was found between the relative increase in RSV-specific IgG levels and the UACR at the time of vaccination (Spearman r = −0.261, P = .030, Fig. 3a). A similar inverse relation was found between the increase in RSV-specific CD4 T cells and UACR or C-reactive protein (CRP) as marker of systemic inflammation, but this did not reach statistical significance (UACR: Spearman r = −0.176, P = .614, Fig. 3a; CRP: r = −0.091, P = .441, Fig. S4a). eGFR correlated positively with RSV-IgG vaccine responses (Spearman r = 0.301, P = .03, Fig. 3b), in line with an inverse correlation of serum urea with RSV-IgG levels (Spearman r = −0.265, P = .024, Fig. S4a), respectively. In a multivariate logistic regression model a significant relationship between UACR and predicted vaccine responder probability defined as having an increase in both RSV-specific IgG and CD4 T cells was observed, showing significant decline of responder probability with high UACR levels (P = .035, Fig. 3c). By contrast, when CD4 T-cell or IgG responses were analyzed individually, no significant association with log-transformed UACR were observed despite a non-significant trend for humoral vaccine response (P = .412 for CD4 responses and P = .077 for IgG responses, Fig. S4b).

Reactogenicity of RSV-vaccination in patients with CKD

Reactogenicity was assessed in all patients using a standardized questionnaire on self-reported adverse events within the first 7 days. No adverse events were reported by 33% of patients, while 61% reported transient local reactions such as pain or swelling at the injection site. Twenty-three percent of patients stated systemic symptoms, most commonly arthralgia, myalgia, fatigue, or elevated body temperature (Fig. 4a and b). None of the symptoms persisted beyond 2 weeks or led to hospitalization. To evaluate a potential association between reactogenicity and cellular immune response, the relative increase in RSV-specific CD4 T cells was compared between patients with and without adverse events. However, no significant differences were observed (Fig. 4c).

DISCUSSION

Due to a lack of specific antiviral therapies and risk for severe disease course in high-risk groups, RSV-vaccination poses a readily available preventive strategy for reducing RSV-associated morbidity and mortality. However, data on immunogenicity and reactogenicity of RSV-vaccination in patients with CKD are still scarce [2]. In line with global endemicity of RSV, we found a high rate of baseline seropositivity across all CKD stages. On vaccination with a single dose of the adjuvanted RSVpreF3-vaccine, a significant increase in pan-RSV-IgG and IgA, RSV-F-specific IgG as well as RSV-specific CD4 T cells was observed already after 14 days. There was no induction of RSV-specific CD8 T cells. The magnitude in the induction of humoral immune response was lower in patients on intermittent hemodialysis, while patients under maintenance medical immunosuppression showed similar cellular and humoral vaccine response as non-immunosuppressed individuals. An advanced CKD stage was associated with a lower humoral immunogenicity, and higher UACR was related to a lower vaccination response in a logistic regression model. RSV-vaccination was well tolerated and most patients reported only minor or transient local adverse events.

The study cohort had a mean age of 74.7 years and a median eGFR of 30 ml/min/1.73 m², representing a high-risk population for RSV-associated lower respiratory tract infections and comparable to other published CKD cohorts [15]. Patients were evenly distributed in terms of KDIGO stages, age, and sex, and their lymphocyte counts did not differ. Comorbidities were comparable across the groups with median prevalence of diabetes of 38.7%, kidney autoimmune disease of 34.7%, and immunosuppressive therapy of 15% [16].

In line with previous reports on RSV seroprevalence, RSV-specific immunoglobulins were detected in all patients at baseline [13, 17, 18]. On vaccination, pan-RSV-IgG, pan-RSV-IgA, and RSV-F-specific IgG significantly increased together with an increase in RSV-specific CD4 T cells as seen in other reports on immunocompromised individuals [13, 19, 20]. Similarly, recent reports found seroconversion in 61% of immunosuppressed patients [21]. Unlike for RSV-specific CD4 T cells, vaccination had no immediate effect on RSV-specific CD8 T cells. This aligns with previous findings on immunogenicity of adjuvanted RSVpreF3-vaccine and other protein-based vaccines such as the shingles-vaccine Shingrix or the COVID-19-vaccine NVX-CoV2373 [22–26]. This lack of effect can be attributed to the mechanism that peptides from protein-based vaccines are primarily presented through MHC class II therefore predominantly triggering a CD4 T-cell response [23].

For patients undergoing intermittent hemodialysis, induction of humoral immune response was significantly lower compared with non-dialysis patients in line with a numerically smaller increase in RSV-specific cellular immune response. Notably, this less pronounced increase in dialysis patients may be due to higher pan-RSV-specific IgG- and CD4 T-cell levels even before vaccination, which likely reflect prior exposure to RSV and underscores their increased infection risk. Despite exclusion of respiratory infection at the time of vaccination, subclinical RSV infection may have contributed to higher baseline levels. As the vaccine-induced immune response was studied early after vaccination and patients did not report any signs or symptoms of infection between vaccination and subsequent analysis, it is considered unlikely, that infections had a confounding effect on immunity measured after vaccination. Despite interindividual differences in the extent of vaccine-induced immune responses, pre-existing immunity may overall explain why a single dose is generally sufficient to induce a boost in immunity in all patients. In contrast, as inferred from COVID-19 vaccine studies [27, 28], one might speculate that a single dose of a vaccine would unlikely to be sufficient to induce a de novo induction of a primary RSV-specific immune response. Overall, our findings align with previous reports of impaired vaccine responses in dialysis patients, including lower antibody responses as well as faster waning of both cellular and humoral immune responses to vaccinations [6, 29, 30]. Similarly, patients under medical immunosuppression exhibited a numerically smaller increase in CD4 and RSV-specific IgG vaccine response without reaching statistical significance. This likely may result from the small sample size and heterogeneity of immunosuppressive regimens, including B-cell depleting antibodies and antimetabolites which are commonly known to impair humoral vaccine response [27, 31]. For the subgroup of immunosuppressed patients receiving complement inhibitors, effects of vaccine immunogenicity are poorly characterized. Preclinical studies suggest that C3b reduces complement activation and humoral response to adenovirus vectors [32], while clinical data indicate impaired antibody neutralization and altered T-cell memory development in viral infections such as influenza [33, 34]. RSV-vaccination immunogenicity has previously been studied in kidney and lung transplant recipients demonstrating strong cellular and humoral vaccine induction [13, 19, 20]. Future studies should address the stability of the vaccine immune response and effectiveness toward protection from RSV infection in both patients with CKD and solid organ transplant recipients.

Heterogeneity of cellular and humoral immune response prompted the question of defining predictive parameters of vaccine response. Interestingly, the increase in RSV-specific IgG but to a lesser extent of CD4 T cells showed an inverse correlation with UACR. Furthermore, there was a significant negative inverse correlation between RSV-specific IgG with serum urea levels as well as a significant positive correlation between RSV-specific IgG and eGFR in line with impaired immune function in uremia. In a multivariate logistic regression model including UACR, eGFR, serum urea, and age as covariates, an exploratory composite vaccine response probability defined as an increase of both RSV-specific IgG and CD4 T cells was in part predicted by prevaccination UACR. This effect was mostly attributable to the humoral vaccine response. There is limited data on vaccine immunogenicity in relation to proteinuria. In a small Japanese cohort, patients with nephrotic syndrome under medical immunosuppression mounted lower spike-specific antibody responses to SARS-CoV-2 vaccination [35]. In a small pediatric cohort with idiopathic nephrotic syndrome, reduced antibody titers against hepatitis B and tetanus were observed despite normal antigen-specific B-cell counts [36]. Although the reason for the diminished immune response in highly proteinuric patients is currently unclear, a possible explanation might be urinary loss of immunoglobulins or potentially even loss of vaccine antigen or adjuvants due to impaired filtration barrier. However, given intramuscular application and lymphatic transport to draining lymph nodes, systemic losses are likely of limited magnitude. Future studies are warranted to validate this observation and to evaluate potential underlying mechanisms responsible for an impaired vaccine response in highly proteinuric patients.

Vaccination using the adjuvanted RSVpreF3-vaccine was well tolerated with mostly transient and primarily local adverse events. Only a minority of patients reported systemic adverse events such as arthralgia or myalgia and no symptoms persisted beyond 7 days. This is in line with previous reports [3], including transplant recipients [13, 20]. Despite some associations between cellular immune responses and systemic adverse events found for other vaccines [37], no significant differences between patients with and without adverse events were found in terms of RSV-specific cellular immune response.

Study limitations are the single-center design without randomization, placebo control or blinding. The size of individual subgroups was relatively small with heterogeneity in comorbidities and medical immunosuppression, limiting the generalizability of our findings. Thus, the results of our subgroup analyses should be considered explorative. Furthermore, our study addresses early immunogenicity, and no data durability of RSV-specific immunoglobulins or on neutralizing activity were collected; together with observational data on effectiveness of the vaccine, this would be an important area for future research to increase clinical interpretability. As we did not systematically test for RSV infection, concurrent respiratory infection may have been present in some patients and contributed to interindividual variability of baseline- and/or vaccine-induced immunity. Larger studies are required to further delineate the role of pre-existing immunity for immunogenicity and durability of the vaccine response. Finally, findings from this study are based on in vitro stimulation assays and do not directly infer clinical vaccine effectiveness in terms of reduced infection risk or disease severity.

CONCLUSION

A single intramuscular dose of the adjuvanted RSVpreF3-vaccine led to a significant cellular and humoral vaccine response in all patients with CKD. This held true for both patients under immunosuppressive therapy and intermittent hemodialysis treatment despite in part lower magnitude of effect in these subgroups. UACR was identified as one of the covariates for predicting vaccine response probability. The vaccine was well tolerated with predominantly local and transient adverse events. As our study focused on early immunogenicity, long-term stability of the immune responses and clinical data are warranted and careful consideration of reduced immunogenicity versus elevated infection risk and high infection-associated mortality remains essential to develop specific vaccination strategies in CKD cohorts.

Supplementary Material

sfag093_Supplemental_File

sfag093_supplemental_file.docx^{(1.4MB, docx)}

ACKNOWLEDGEMENTS

We thank Ellen Becker, Claudia Noll, Caroline Abbosh, Candida Guckelmus, and Rebecca Urschel for excellent technical assistance, and Fabio Lizzi and the team of the Saarland University Medical center for their support in enrolling participants. We also thank all participants to this study who contributed to the gain in knowledge from this project.

Contributor Information

Richard Radun, Department of Internal Medicine IV, Saarland University Medical Center, Campus Homburg, Homburg, Germany.

Saskia Bronder, Department of Transplant and Infection Immunology, PharmaScienceHub (PSH), Saarland University, Homburg, Germany.

Amina Abu-Omar, Department of Internal Medicine IV, Saarland University Medical Center, Campus Homburg, Homburg, Germany.

Danilo Fliser, Department of Internal Medicine IV, Saarland University Medical Center, Campus Homburg, Homburg, Germany.

Martina Sester, Department of Transplant and Infection Immunology, PharmaScienceHub (PSH), Saarland University, Homburg, Germany; Center for Gender-specific Biology and Medicine (CGBM), Saarland University, Homburg, Germany.

David Schmit, Department of Internal Medicine IV, Saarland University Medical Center, Campus Homburg, Homburg, Germany.

AUTHORS’ CONTRIBUTIONS

R.R., S.B., A.A.-O., D.S., D.F., and M.S. designed the study and the experiments. S.B. performed flow cytometry measurements, R.R. performed F-specific ELISA tests, S.B. and A.A.-O. performed RSV-IgG and IgA ELISA tests. R.R., A.A.-O., D.F., and D.S. contributed to patient recruitment, and clinical data acquisition. D.F., D.S., and M.S. supervised all parts of the study. R.R., S.B., and M.S. performed statistical analyses and wrote the paper. All authors approved the final version of the paper.

CONFLICT OF INTEREST STATEMENT

A.A.-O. has received travel support and honoraria for lectures from Biotest. M.S. has received grant support from Astellas, Biotest, and Takeda to the organization Saarland University outside the submitted work, and honoraria for lectures from Biotest and Novartis, and for advisory boards from Moderna, Biotest, MSD, and Takeda. All other authors of this paper have no conflicts of interest to disclose.

DATA AVAILABILITY STATEMENT

All figures and tables have associated raw data. The data that support the findings of this study are available from the corresponding authors upon request.

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12. Girndt M, Sester U, Sester M et al. ; Impaired cellular immune function in patients with end-stage renal failure. Nephrol Dial Transplant. 1999;14:2807–10. 10.1093/ndt/14.12.2807 [DOI] [PubMed] [Google Scholar]
13. Bronder S, Abu-Omar A, Lennartz S et al. Cellular and humoral immunogenicity of respiratory syncytial virus vaccination in solid organ transplant recipients. Am J Transplant. 2026;26:499–511. 10.1016/j.ajt.2025.09.023 [DOI] [PubMed] [Google Scholar]
14. Urschel R, Bronder S, Klemis V et al. SARS-CoV-2-specific cellular and humoral immunity after bivalent BA.4/5 COVID-19-vaccination in previously infected and non-infected individuals. Nat Commun. 2024;15:3077. 10.1038/s41467-024-47429-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
15. Liu P, Quinn RR, Lam NN et al. Progression and regression of chronic kidney disease by age among adults in a population-based cohort in Alberta, Canada. JAMA Netw Open. 2021;4:e2112828. 10.1001/jamanetworkopen.2021.12828 [DOI] [PMC free article] [PubMed] [Google Scholar]
16. Fenta ET, Eshetu HB, Kebede N et al. Prevalence and predictors of chronic kidney disease among type 2 diabetic patients worldwide, systematic review and meta-analysis. Diabetol Metab Syndr. 2023;15:245. 10.1186/s13098-023-01202-x [DOI] [PMC free article] [PubMed] [Google Scholar]
17. Teodoro LI, Ovsyannikova IG, Grill DE et al. ; Seroprevalence of RSV antibodies in a contemporary (2022-2023) cohort of adults. Int J Infect Dis. 2025;158:107964. 10.1016/j.ijid.2025.107964 [DOI] [PubMed] [Google Scholar]
18. Poniedzialek B, Majewska W, Kondratiuk K et al. Seroprevalence of RSV IgG antibodies across age groups in poland after the COVID-19 pandemic: data from the 2023/2024 epidemic season. Vaccines. 2025;13:741. 10.3390/vaccines13070741 [DOI] [PMC free article] [PubMed] [Google Scholar]
19. Havlin J, Skotnicova A, Dvorackova E et al. Respiratory syncytial virus prefusion F3 vaccine in lung transplant recipients elicits CD4⁺ T cell response in all vaccinees. Am J Transplant. 2025;25:1452–60. 10.1016/j.ajt.2025.03.025 [DOI] [PubMed] [Google Scholar]
20. Hall VG, Alexander AA, Mavandadnejad F et al. Safety and immunogenicity of adjuvanted respiratory syncytial virus vaccine in high-risk transplant recipients: an interventional cohort study. Clin Microbiol Infect. 2026;32:161–168. 10.1016/j.cmi.2025.09.013 [DOI] [PubMed] [Google Scholar]
21. Karaba AH, Hage C, Sengsouk I et al. Antibody response to respiratory syncytial virus vaccination in immunocompromised persons. JAMA. 2025;333:429–32. 10.1001/jama.2024.25395 [DOI] [PMC free article] [PubMed] [Google Scholar]
22. Leroux-Roels I, Davis MG, Steenackers K et al. Safety and immunogenicity of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine in older adults: Phase 1/2 randomized clinical trial. J Infect Dis. 2023;227:761–72. 10.1093/infdis/jiac327 [DOI] [PMC free article] [PubMed] [Google Scholar]
23. Zhang Z, Mateus J, Coelho CH et al. Humoral and cellular immune memory to four COVID-19 vaccines. Cell. 2022;185:2434–2451. 10.1016/j.cell.2022.05.022 [DOI] [PMC free article] [PubMed] [Google Scholar]
24. Schwarz TF, Hwang SJ, Ylisastigui P et al. Immunogenicity and safety following 1 dose of AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine in older adults: a Phase 3 trial. J Infect Dis. 2024;230:e102–10. 10.1093/infdis/jiad546 [DOI] [PMC free article] [PubMed] [Google Scholar]
25. Hielscher F, Schmidt T, Enders M et al. The inactivated herpes zoster vaccine HZ/su induces a varicella zoster virus specific cellular and humoral immune response in patients on dialysis. EBioMed. 2024;108:105335. 10.1016/j.ebiom.2024.105335 [DOI] [PMC free article] [PubMed] [Google Scholar]
26. Hielscher F, Schmidt T, Klemis V et al. NVX-CoV2373-induced cellular and humoral immunity towards parental SARS-CoV-2 and VOCs compared to BNT162b2 and mRNA-1273-regimens. J Clin Virol. 2022;157:105321. 10.1016/j.jcv.2022.105321 [DOI] [PMC free article] [PubMed] [Google Scholar]
27. Stumpf J, Siepmann T, Lindner T et al. Humoral and cellular immunity to SARS-CoV-2 vaccination in renal transplant versus dialysis patients: a prospective, multicenter observational study using mRNA-1273 or BNT162b2 mRNA vaccine. Lancet Regional Health—Eur. 2021;9:100178. 10.1016/j.lanepe.2021.100178 [DOI] [PMC free article] [PubMed] [Google Scholar]
28. Karakizlis H, Nahrgang C, Strecker K et al. Immunogenicity and reactogenicity of homologous mRNA-based and vector-based SARS-CoV-2 vaccine regimens in patients receiving maintenance dialysis. Clin Immunol. 2022;236:108961. 10.1016/j.clim.2022.108961 [DOI] [PMC free article] [PubMed] [Google Scholar]
29. Espi M, Koppe L, Fouque D et al. ; Chronic kidney disease-associated immune dysfunctions: impact of protein-bound uremic retention solutes on immune cells. Toxins. 2020; 12:300. 10.3390/toxins12050300 [DOI] [PMC free article] [PubMed] [Google Scholar]
30. Girndt M, Sester M, Sester U et al. ; Defective expression of B7-2 (CD86) on monocytes of dialysis patients correlates to the uremia-associated immune defect. Kidney Int. 2001;59:1382–9. 10.1046/j.1523-1755.2001.0590041382.x [DOI] [PubMed] [Google Scholar]
31. van der Kolk LE, Baars JW, Prins MH et al. ; Rituximab treatment results in impaired secondary humoral immune responsiveness. Blood. 2002;100:2257–9. 10.1182/blood.V100.6.2257 [DOI] [PubMed] [Google Scholar]
32. Mellors J, Tipton T, Longet S et al. ; Viral evasion of the complement system and its importance for vaccines and therapeutics. Front Immunol. 2020;11:1450. 10.3389/fimmu.2020.01450 [DOI] [PMC free article] [PubMed] [Google Scholar]
33. S FG, Jayasekera JP, MC; C. Complement and natural antibody are required in the long-term memory response to influenza virus. Vaccine. 2008;26:I86–93. [DOI] [PubMed] [Google Scholar]
34. Kopf M, Abel B, Gallimore A et al. ; Complement component C3 promotes T-cell priming and lung migration to control acute influenza virus infection. Nat Med. 2002;8:373–8. 10.1038/nm0402-373 [DOI] [PubMed] [Google Scholar]
35. Colucci M, Piano Mortari E, Zotta F et al. Evaluation of immune and vaccine competence in steroid-sensitive nephrotic syndrome pediatric patients. Front Immunol. 2021;12:602826. 10.3389/fimmu.2021.602826 [DOI] [PMC free article] [PubMed] [Google Scholar]
36. Kamei K, Ogura M, Sato M et al. Immunogenicity and safety of SARS-CoV-2 mRNA vaccine in patients with nephrotic syndrome receiving immunosuppressive agents. Pediatr Nephrol. 2023;38:1099–106. 10.1007/s00467-022-05633-y [DOI] [PMC free article] [PubMed] [Google Scholar]
37. Schmidt T, Klemis V, Schub D et al. Cellular immunity predominates over humoral immunity after homologous and heterologous mRNA and vector-based COVID-19 vaccine regimens in solid organ transplant recipients. Am J Transplant. 2021;21:3990–4002. 10.1111/ajt.16818 [DOI] [PMC free article] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

sfag093_Supplemental_File

sfag093_supplemental_file.docx^{(1.4MB, docx)}

Data Availability Statement

All figures and tables have associated raw data. The data that support the findings of this study are available from the corresponding authors upon request.

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[bib19] 19. Havlin J, Skotnicova A, Dvorackova E et al. Respiratory syncytial virus prefusion F3 vaccine in lung transplant recipients elicits CD4⁺ T cell response in all vaccinees. Am J Transplant. 2025;25:1452–60. 10.1016/j.ajt.2025.03.025 [DOI] [PubMed] [Google Scholar]

[bib20] 20. Hall VG, Alexander AA, Mavandadnejad F et al. Safety and immunogenicity of adjuvanted respiratory syncytial virus vaccine in high-risk transplant recipients: an interventional cohort study. Clin Microbiol Infect. 2026;32:161–168. 10.1016/j.cmi.2025.09.013 [DOI] [PubMed] [Google Scholar]

[bib21] 21. Karaba AH, Hage C, Sengsouk I et al. Antibody response to respiratory syncytial virus vaccination in immunocompromised persons. JAMA. 2025;333:429–32. 10.1001/jama.2024.25395 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib22] 22. Leroux-Roels I, Davis MG, Steenackers K et al. Safety and immunogenicity of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine in older adults: Phase 1/2 randomized clinical trial. J Infect Dis. 2023;227:761–72. 10.1093/infdis/jiac327 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib23] 23. Zhang Z, Mateus J, Coelho CH et al. Humoral and cellular immune memory to four COVID-19 vaccines. Cell. 2022;185:2434–2451. 10.1016/j.cell.2022.05.022 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib24] 24. Schwarz TF, Hwang SJ, Ylisastigui P et al. Immunogenicity and safety following 1 dose of AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine in older adults: a Phase 3 trial. J Infect Dis. 2024;230:e102–10. 10.1093/infdis/jiad546 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib25] 25. Hielscher F, Schmidt T, Enders M et al. The inactivated herpes zoster vaccine HZ/su induces a varicella zoster virus specific cellular and humoral immune response in patients on dialysis. EBioMed. 2024;108:105335. 10.1016/j.ebiom.2024.105335 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib26] 26. Hielscher F, Schmidt T, Klemis V et al. NVX-CoV2373-induced cellular and humoral immunity towards parental SARS-CoV-2 and VOCs compared to BNT162b2 and mRNA-1273-regimens. J Clin Virol. 2022;157:105321. 10.1016/j.jcv.2022.105321 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib27] 27. Stumpf J, Siepmann T, Lindner T et al. Humoral and cellular immunity to SARS-CoV-2 vaccination in renal transplant versus dialysis patients: a prospective, multicenter observational study using mRNA-1273 or BNT162b2 mRNA vaccine. Lancet Regional Health—Eur. 2021;9:100178. 10.1016/j.lanepe.2021.100178 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib28] 28. Karakizlis H, Nahrgang C, Strecker K et al. Immunogenicity and reactogenicity of homologous mRNA-based and vector-based SARS-CoV-2 vaccine regimens in patients receiving maintenance dialysis. Clin Immunol. 2022;236:108961. 10.1016/j.clim.2022.108961 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib29] 29. Espi M, Koppe L, Fouque D et al. ; Chronic kidney disease-associated immune dysfunctions: impact of protein-bound uremic retention solutes on immune cells. Toxins. 2020; 12:300. 10.3390/toxins12050300 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib30] 30. Girndt M, Sester M, Sester U et al. ; Defective expression of B7-2 (CD86) on monocytes of dialysis patients correlates to the uremia-associated immune defect. Kidney Int. 2001;59:1382–9. 10.1046/j.1523-1755.2001.0590041382.x [DOI] [PubMed] [Google Scholar]

[bib31] 31. van der Kolk LE, Baars JW, Prins MH et al. ; Rituximab treatment results in impaired secondary humoral immune responsiveness. Blood. 2002;100:2257–9. 10.1182/blood.V100.6.2257 [DOI] [PubMed] [Google Scholar]

[bib32] 32. Mellors J, Tipton T, Longet S et al. ; Viral evasion of the complement system and its importance for vaccines and therapeutics. Front Immunol. 2020;11:1450. 10.3389/fimmu.2020.01450 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib33] 33. S FG, Jayasekera JP, MC; C. Complement and natural antibody are required in the long-term memory response to influenza virus. Vaccine. 2008;26:I86–93. [DOI] [PubMed] [Google Scholar]

[bib34] 34. Kopf M, Abel B, Gallimore A et al. ; Complement component C3 promotes T-cell priming and lung migration to control acute influenza virus infection. Nat Med. 2002;8:373–8. 10.1038/nm0402-373 [DOI] [PubMed] [Google Scholar]

[bib35] 35. Colucci M, Piano Mortari E, Zotta F et al. Evaluation of immune and vaccine competence in steroid-sensitive nephrotic syndrome pediatric patients. Front Immunol. 2021;12:602826. 10.3389/fimmu.2021.602826 [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib36] 36. Kamei K, Ogura M, Sato M et al. Immunogenicity and safety of SARS-CoV-2 mRNA vaccine in patients with nephrotic syndrome receiving immunosuppressive agents. Pediatr Nephrol. 2023;38:1099–106. 10.1007/s00467-022-05633-y [DOI] [PMC free article] [PubMed] [Google Scholar]

[bib37] 37. Schmidt T, Klemis V, Schub D et al. Cellular immunity predominates over humoral immunity after homologous and heterologous mRNA and vector-based COVID-19 vaccine regimens in solid organ transplant recipients. Am J Transplant. 2021;21:3990–4002. 10.1111/ajt.16818 [DOI] [PMC free article] [PubMed] [Google Scholar]

PERMALINK

Immunogenicity and reactogenicity of the adjuvanted respiratory syncytial virus vaccine in patients with chronic kidney disease

Richard Radun

Saskia Bronder

Amina Abu-Omar

Danilo Fliser

Martina Sester

David Schmit

ABSTRACT

Background

Methods

Results

Conclusions

GRAPHICAL ABSTRACT

GRAPHICAL ABSTRACT.

KEY LEARNING POINTS.

INTRODUCTION

MATERIALS AND METHODS

Study design and subjects

Quantification and characterization of RSV-specific CD4 and CD8 T cells

Determination of RSV-specific antibodies

Statistical analysis

RESULTS

Study population

Table 1:

Vaccine-induced humoral and cellular immunity in patients with CKD

Figure 1:

Functional and phenotypical characterization of RSV-specific T cells

Immunogenicity in CKD subgroups

Figure 2:

Clinical correlations and predictors of immune response

Figure 3:

Reactogenicity of RSV-vaccination in patients with CKD

Figure 4:

DISCUSSION

CONCLUSION

Supplementary Material

ACKNOWLEDGEMENTS

Contributor Information

AUTHORS’ CONTRIBUTIONS

CONFLICT OF INTEREST STATEMENT

DATA AVAILABILITY STATEMENT

REFERENCES

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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