At IDWeek 2025, held on 19–22 October, Dr Eric Mayer from Moderna shared data from a Phase III trial assessing the safety, tolerability, and immunogenicity of Moderna’s mRNA-1345 respiratory syncytial virus (RSV) vaccine in solid organ transplant (SOT) recipients in patients aged 18 years and older. RSV is a common respiratory pathogen that causes significant global disease. Immunocompromised status is significantly associated with increased risk of RSV infection, and specifically mortality. Key opinion leaders previously interviewed by GlobalData noted the need for more data on current RSV vaccines and their use in the immunocompromised cohort. mRESVIA has been approved in major markets including the US, the EU, Japan, and Australia for the prevention of RSV lower respiratory-tract disease (LRTD) in adults older than age 60 years, and in adults ages 18–59 years who are at an increased risk for RSV-LRTD. mRESVIA was the third RSV prophylactic vaccine to enter the global market, having first been approved in the US in May 2024. This followed the earlier approvals of GSK’s Arexvy and Pfizer’s Abrysvo, both of which were first approved in the US in May 2023.
In this open-label study (NCT06067230), 48 kidney recipients, 46 lung recipients, 48 liver recipients, and eight multi-organ recipients received a two-dose regimen of 50micrograms mRNA-1345 around 60 days apart. All candidates received their transplant at least 180 days prior to the onset of the trial. The primary objective was the safety of mRNA-1345 in the SOT population, as determined through observing any adverse events (AEs), and immunogenicity was tested through measuring RSV-A and RSV-B neutralizing antibodies (nAbs) geometric mean titers (GMTs) after two doses of mRNA-1345 administered two months apart.
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Trial results demonstrated that mRNA-1345 was safe in SOT recipients, with results displaying a similar profile to the current known profile of the drug. Solicited adverse reactions were mostly grade 1–2, occurred within 1–2 days of injection, and resolved within 2–3 days. Injection site pain was the most frequent local reaction, with fatigue, headache, and myalgia being the main systemic reactions. Only one grade 4 AE was reported as being related to treatment but was confounded by the administration of rabbit anti-thrombocyte globulin 14 days prior. No AEs led to vaccine discontinuation or deaths within 28 days of any dose reported.
Trial results demonstrated that mRNA-1345 was effective in SOT recipients, with results displaying a similar profile to the current known profile of the drug. One dose of mRNA-1345 was immunogenic in all SOT types, with measurable increases in RSV-A and RSV-B nAb GMTs by day 29. Responses were durable through day 181, with geometric mean fold rises remaining above baseline for both RSV-A and RSV-B, consistent across all transplant types. Increased nAb responses after the second dose were observed in participants within two years of transplant, most notably in kidney and lung recipients, as well as those receiving the immunosuppressant mycophenolate mofetil. This indicates that within two years post-transplant, recipients and those on certain immunosuppressive agents may benefit from a second dose of mRNA-1345.
The use of mRNA-1345 in transplant recipients is safe and effective, and some patients may benefit from a second dose. These findings are useful for clinicians in order to further understand the response of mRNA-1345 in the immunocompromised patient cohort, since guidelines in the major markets do recommend RSV vaccination in SOT recipients.
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