Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
Immunogenicity of High-Dose Versus MF59-Adjuvanted Versus Standard Influenza Vaccine in Solid Organ Transplant Recipients: The Swiss/Spanish Trial in Solid Organ Transplantation on Prevention of Influenza (STOP-FLU Trial).
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03699839 (Reducing the Burden of Influenza After Solid-Organ Transplantation), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Reducing the Burden of Influenza After Solid-Organ Transplantation: the STOP-FLU Trial [Swiss Trial in Solid Organ Transplantation on Prevention of Influenza]
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.
- Influenza vaccination in solid organ transplant recipients: A systematic review and network meta-analysis of randomized trials.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2026Pooled it
- Pooled it
- Immunogenicity and safety of high-dose versus double-dose quadrivalent inactivated influenza vaccine in adult kidney transplant recipients: a randomized controlled trial (2023).The Lancet regional health. Southeast Asia · 2026Article
- Reactogenicity and Immunogenicity of Adjuvanted and Nonadjuvanted RSV Vaccines in Solid Organ Transplant Recipients.Transplantation direct · 2026Article
- Durability of Respiratory Syncytial Virus Antibodies After Vaccination in Immunosuppressed Persons.Open forum infectious diseases · 2026Article
- Not just another shot: Tailoring vaccination in the era of modern liver transplantation.World journal of transplantation · 2026Review
- Influenza Vaccines for Persons Who Are Immunocompromised: A Scoping Review of the Literature.Open forum infectious diseases · 2026Article
- Viral infections in solid organ transplant recipients: immunological principles and intervention strategies.American journal of translational research · 2026Review
- Innovation in active and passive immunisation of people who are immunocompromised: a call to action.The Lancet. Infectious diseases · 2026Review
- Review
- Respiratory viral infections in lung transplantation: Recent advances in epidemiology, clinical impact, and therapeutic approaches.JHLT open · 2025Article
- Recommendations for Influenza Vaccination in Immunocompromised Patients.Infection & chemotherapy · 2025Review
- Vaccines for Use in Special Populations: Immunocompromised Hosts.The Journal of infectious diseases · 2025Article
- A Retrospective Test-Negative Case-Control Study to Evaluate Influenza Vaccine Effectiveness in Preventing Influenza Among Immunocompromised Adults With a Solid Organ Transplant.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
Corrections and comments
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Authors and funding
31 authors at 12 institutions in 2 countries.
Funding
Abstract
backgroundThe immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so new vaccination strategies are needed in this population.
methodsAdult SOT recipients from 9 transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. Patients were randomized (1:1:1) to a MF59-adjuvanted or a high-dose vaccine (intervention), or a standard vaccine (control), with stratification by organ and time from transplant. The primary outcome was vaccine response rate, defined as a ≥4-fold increase of hemagglutination-inhibition titers to at least 1 vaccine strain at 28 days postvaccination. Secondary outcomes included polymerase chain reaction-confirmed influenza and vaccine reactogenicity.
resultsA total of 619 patients were randomized, 616 received the assigned vaccines, and 598 had serum available for analysis of the primary endpoint (standard, n = 198; MF59-adjuvanted, n = 205; high-dose, n = 195 patients). Vaccine response rates were 42% (84/198) in the standard vaccine group, 60% (122/205) in the MF59-adjuvanted vaccine group, and 66% (129/195) in the high-dose vaccine group (difference in intervention vaccines vs standard vaccine, 0.20; 97.5% confidence interval [CI], .12-1); P < .001; difference in high-dose vs standard vaccine, 0.24 [95% CI, .16-1]; P < .001; difference in MF59-adjuvanted vs standard vaccine, 0.17 [97.5% CI, .08-1]; P < .001). Influenza occurred in 6% of the standard, 5% in the MF59-adjuvanted, and 7% in the high-dose vaccine groups. Vaccine-related adverse events occurred more frequently in the intervention vaccine groups, but most of the events were mild.
conclusionsIn SOT recipients, use of an MF59-adjuvanted or a high-dose influenza vaccine was safe and resulted in a higher vaccine response rate. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT03699839.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.