International Journal of Clinical Case Reports 2024, Vol.14, No.5, 230-241 http://medscipublisher.com/index.php/ijccr 235 frequently reported but typically resolve on their own within a few days. For instance, a study evaluating a pancreatic cancer stem cell vaccine found that the most common adverse effects were injection site reactions (54%) and fever (9%), with no significant variation among different dose groups (Lin et al., 2015). Some vaccines, particularly those combined with immune checkpoint inhibitors (ICIs), may induce immune-related adverse events (irAEs), which can affect multiple organs. For example, patients receiving the influenza vaccine while on ICIs were found to have a higher frequency of irAEs, such as pneumonitis and rash, although these events were manageable (Spagnolo et al., 2021). In rare cases, more serious adverse events can occur, such as autoimmune reactions that affect the liver, lungs, or endocrine system. However, these events are typically low in frequency, and when they do occur, they are often treatable with immunosuppressive medications such as corticosteroids (Xu et al., 2018). 4.2 Long-term safety evaluation Long-term safety data for cancer vaccines are crucial to understand their sustained effects and potential late-onset adverse events. A study on patients receiving personalized peptide vaccines (PPV) for lung, colon, and breast cancer reported that no severe long-term adverse events were observed during a median follow-up period of 67.6 months. Most patients experienced sustained immune responses, with only minor injection site reactions being the most common adverse event (Suekane et al., 2022). Studies on combination therapies involving cancer vaccines and ICIs also provide insight into long-term safety. For example, cancer patients who received the influenza vaccine while on pembrolizumab, an anti-PD-1 agent, did not experience an increased rate of serious immune-related events over a 12-month follow-up period, supporting the vaccine's long-term safety in this population (Failing et al., 2020). It is important to note that late-onset adverse events-those occurring months or years after vaccination-are rare but possible, particularly in patients receiving multiple rounds of immunotherapy. Therefore, continued long-term monitoring is essential for evaluating vaccine safety in diverse patient populations (Kyte et al., 2016). 4.3 Management of immune-related adverse events Management of immune-related adverse events (irAEs) is critical in ensuring patient safety, particularly when vaccines are combined with ICIs. Corticosteroids remain the cornerstone of treatment for moderate to severe irAEs. For instance, corticosteroids are often prescribed to manage irAEs such as pneumonitis, colitis, or hepatitis, which are relatively common with immune checkpoint blockade (Rahman et al., 2022). In some cases, if patients do not respond to corticosteroid treatment, additional immunosuppressive agents such as infliximab or mycophenolate mofetil may be necessary. These treatment plans need to be carefully monitored to minimize the risk of secondary infections or other complications. Based on the analysis in the above figure, cancer patients receiving immune checkpoint inhibitors (ICIs) treatment showed a relatively concentrated incidence of immune related adverse events (irAEs) after receiving SARS-CoV-2 vaccine, especially within 30 to 60 days after vaccination (Guo et al., 2024). Although the occurrence of irAEs is related to the timing of vaccination and the type of immunotherapy, through meticulous monitoring and management, the immune response can be controlled, ensuring that adverse events remain within a controllable range. For example, studies on the combination of COVID-19 vaccination and ICIs have shown that despite the occurrence of irAEs these adverse events are kept at a minimal level and mostly manageable with continuous immune response monitoring and appropriate management of patients (Widman et al., 2022). Therefore, these patients should be closely followed up at critical time points after vaccination (such as within 30-60 days) to promptly address any potential irAEs. A multidisciplinary approach is often required for managing severe or complex irAEs, involving oncologists, immunologists, and other specialists to provide comprehensive care. This approach helps mitigate the risk of
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