Co-vaccination of seasonal influenza and respiratory syncytial virus (RSV) in people at high risk of heart failure (HF) was shown to be safe with a low incidence of adverse events, according to study results published in 2017. vaccine. Researchers conducted a single-center, randomized trial to investigate co-vaccination with influenza and RSV compared to influenza vaccine alone.

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According to the study authors, researchers aimed to determine the early safety profile of vaccination in the active study arm. Patients included in this study had advanced heart failure with a left ventricular assist device implanted, had been hospitalized for acute heart failure within the past 18 months, and had severe aortic disease awaiting catheter-based aortic valve implantation. Patients had stenosis or had a left ventricular ejection fraction less than 35% and were taking daily diuretics. 80 mg furosemide or equivalent dose.

The endpoint was vaccine-related reactions, including injection site erythema, swelling and pain, fever, malaise, myalgia, arthralgia, headache, influenza-like symptoms, worsening of general condition, allergic or systemic reactions, and additional Includes drug use. Additionally, the study authors said they recorded data on events specific to HF, including increased diuretic doses, worsening of HF signs and symptoms, weight gain, hospitalization for acute HF, and death. It is said that it was included.

In the active arm of the study, researchers had 105 participants, 78 of whom were male and the average age was 66 years. All were white and 11 were smokers, study authors said. Approximately 89% were taking beta blockers, 89% were taking angiotensin converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitors, and 75% were taking mineralocorticoid receptor antagonists. 71% were taking SGLT-2 inhibitors; 68% were taking SGLT-2 inhibitors. Loop diuretics.

During the first four days after vaccination, approximately 65% ​​of people reported no symptoms and 21% reported a mild effect on their overall comfort. According to the study authors, only 17% of people reported any deterioration in their health on the first day, but only 4% mentioned physical and mental fatigue by the fourth day. The most common vaccine-related reactions included injection site reactions in 75%, fatigue in 22%, and injection site swelling in 13%. The researchers also noted that swelling and erythema are characteristic of RSV vaccination. Erythema on the injection side was approximately 10% on the first day and 11% on the second day.

The results showed that on the first day, 4% had fever, 22% had fatigue, 9% had headache, 11% had muscle pain, and 6% had joint pain. Grade 3 reactions occurred in 6% of patients and were defined as reactions severe enough to interfere with normal daily life, according to the researchers. In addition, 6 people experienced a fever of 38°C (100.4°F) or higher for at least one day. According to the results, two people showed flu-like symptoms and five people took fever-reducing medication.

However, the researchers found that none of the vaccinated people experienced a significant worsening of signs and symptoms associated with heart failure, and two people did not take diuretics during the first day after vaccination. He pointed out that the amount needed to be increased. Furthermore, these people did not report worsening of heart failure symptoms. No patients were hospitalized or died in the week after vaccination. Additionally, the study authors said there were no reports of shock or other adverse events associated with the implantable cardioverter-defibrillator.

reference

Biegus J, Szenborn L, Zymliński R et al. Early safety profile of co-vaccination against influenza and respiratory syncytial virus (RSV) in high-risk heart failure patients. vaccine. 2024.doi:10.1016/j.vaccine.2024.03.060