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Study: RSV Vaccine Response in Lung Transplant Recipients
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Key Takeaways
- RSV poses a significant threat to lung transplant recipients, with limited treatment options available, emphasizing the need for effective vaccination strategies.
- The Arexvy vaccine, containing RSVPreF3 and AS01E adjuvant, was FDA-approved in 2023 for preventing RSV-related LRTI in adults aged 60 and older.
A recent study highlights the promising immune response and safety of the Arexvy vaccine in lung transplant recipients, crucial for preventing RSV infections.
Respiratory syncytial virus (RSV) poses a serious threat to lung transplant (LTx) recipients, contributing significantly to illness and death within this vulnerable population where effective treatments are limited. The development of the Arexvy vaccine (RSVPreF3; GSK) has demonstrated considerable promise in generating protective immunity among healthy adults; however, its ability to stimulate an adequate immune response in individuals with compromised immune systems, such as organ transplant recipients, remains an important area of investigation.1
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A single-center retrospective study, published by investigators in the journal Vaccines, aimed to evaluate the immunogenicity and safety of the Arexvy vaccine in a cohort of LTx recipients who received vaccination in February 2024, analyzing their antibody responses over a 6-month period.1
RSV Vaccine Response
RSV is known to cause severe lower respiratory tract infection (LRTI) in older adults aged 60 years and older, contributing to morbidity and mortality. Individuals in need of lung transplants are more susceptible to infections due to their immunocompromised status. Currently, guidelines weakly recommend ribavirin tablets, potentially with intravenous immunoglobulin (IVIG) or corticosteroids, for RSV in LTx recipients due to limited evidence from previous observational studies. However, as no specific antiviral exists, the investigators emphasize the prevention of RSV infection through vaccination to protect this population group.1
Approved by the FDA in May 2023, Arexvy was the first RSV vaccine accepted in the US for the prevention of LRTI caused by RSV infection in individuals aged 60 years and older. The vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. Despite its positive efficacy data from clinical trials, further research is needed to assess its immunogenicity against seasonal RSV strains in LTx recipients.1
Immunogenicity of Arexvy in Lung Transplant Recipients
A total of 28 LTx recipients were included in the single-center retrospective cohort study, with a median age at the time of transplantation of 59 years and 62 years at the time of vaccination. The median time from transplant to vaccination was 486 days. All individuals were followed at the Sheba Medical Center LTx clinic.1
Following vaccine administration with Arexvy in February 2024, all patients were routinely followed every 3 to 6 months as part of standard clinical care and were notified to contact the clinic if any respiratory or fever symptoms occurred between each follow-up visit. Additionally, adverse events (AEs), including injection-site and systemic reactions, were monitored for 7 days post-vaccination. Clinical and laboratory data, including blood samples, were collected at baseline and 1, 3, and 6 months following vaccination, with a 2-week window for post-vaccination time points, and retrospectively extracted from patient records for analysis.1
Of the 28 LTx recipients in the study, 75% were male and nearly 90% had received bilateral transplants, with pulmonary fibrosis being the most prevalent underlying condition (67.9%). The majority (71.4%) were donor-positive/recipient-positive cytomegalovirus, and mild, localized injection-site reactions were reported by 28.6% of participants as the only AEs. Importantly, no RSV infections occurred in the study group before or after vaccination.1
The results from the micro-neutralization assays demonstrated a significant increase in neutralizing antibodies against all 4 variants (RSV A/B ATCC and seasonal RSV A/B) by 6 months post-vaccination in lung transplant recipients. Specifically, the geometric mean titer (GMT) for RSV A ATCC increased from 409 to 2242 (p < 0.0001), and for RSV B ATCC, from 860 to 2602 (p < 0.0001). Seasonal RSV A GMTs rose from 1855 to 3856 (p = 0.07), and seasonal RSV B GMTs increased from 430 to 1121 (p = 0.0132). Baseline immunity against circulating RSV A was higher compared with other variants, whereas neutralizing capacity against seasonal RSV B was initially lower.1
The findings suggest increased levels in neutralizing antibody levels at 3 and 6 months post-vaccination in LTx recipients. Additionally, the study authors noted that the antibody responses were maintained in the 6-month follow-up period, signifying stable immunogenicity. Significantly, no safety concerns were reported, emphasizing Arexvy’s tolerability among immunocompromised patients.1
