Randomized trial investigating the safety and efficacy of influenza vaccination in patients with antineutrophil cytoplasmic antibody-associated vasculitis

Aim: This study evaluated the safety and efficacy of influenza vaccination in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Methods: Thirty-one patients who were in remission were randomized to receive either a trivalent influenza vaccine or no vaccine. Vaccine efficacy was assessed at 28 days. Patients were followed for 6 months for signs of reactivation of disease. In addition, 67 healthy individuals were randomized to receive either the influenza vaccine or no vaccine to assess its potential for triggering the formation of autoantibodies. Results: Compared with patients who did not receive the vaccine, vaccinated patients achieved effective responses to all three influenza vaccine antigens. There was no significant change in levels of anti-neutrophil cytoplasmic antibody post-vaccination. There was no significant change in disease activity in vaccinated patients compared with non-vaccinated patients. Among vaccinated healthy individuals, we did not observe any significant change in the level of autoantibodies measured. Conclusion: This study shows that the administration of influenza vaccine to patients in remission with anti-neutrophil cytoplasmic antibody-associated vasculitis is both safe and modestly efficacious.