Sex: F
Vaccine: HEP
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Scleroderma
Clinical narrative: This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 44-year-old female subject who received Hepatitis B vaccine. Previously administered products included ENGERIX (dose 1). On an unknown date, 127 days after receiving Hepatitis B vaccine, the subject developed anti-neutrophil cytoplasmic antibody positive vasculitis. Serious criteria included GSK medically significant. Additional event(s) included scleroderma with serious criteria of GSK medically significant. The outcome of anti-neutrophil cytoplasmic antibody positive vasculitis was unknown. The outcome(s) of the additional event(s) included scleroderma (unknown). It was unknown if the investigator considered the anti-neutrophil cytoplasmic antibody positive vasculitis and scleroderma to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature and described the occurrence of anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis and scleroderma in a female patient aged 44 years who was vaccinated with ENGERIX (GlaxoSmithKline). The patient was part of a post hoc analysis that compared the safety of HBsAg-1018 with HBsAg-Eng (ENGERIX-B), in 3 randomised, observer-blind, active-controlled, multi-centre phase 3 trials in adults. [Eligible participants in HBV-10 and HBV-16 were generally healthy volunteers but HBV-23 did not specify that participants must be generally healthy. Subjects in all three pivotal trials were serum negative for HBsAg, anti-HBs, and antibody to hepatitis B core antigen (anti-HBc); had no history of HBV infection; had no history of prior immunization with any hepatitis B vaccine; did not have human immunodeficiency virus infection; had no autoimmune disease; and were not pregnant. In HBV-10, 2415 adults 18-55 years of age were randomized in a 3:1 ratio to receive HBsAg-1018 or HBsAg-Eng and were followed for 28 weeks after the first injection]. The patient was healthy and belonged to HBV-10 pivotal trials group. No information on patient's family history or concomitant medication was provided. On unspecified dates at weeks 0 and 4, the patient received 2 doses of ENGERIX intramuscularly (administration site unspecified, batch number not provided). [In this study, HBsAg-Eng (ENGERIX-B GlaxoSmithKline Biologicals) consists of 20 mcg of recombinant HBsAg combined with 0.5 mg of aluminum hydroxide (alum) adjuvant per 1.0 mL dose. Participants in the HBsAg-Eng group received the Food and Drug Administration (FDA) approved regimen of intramuscular injections at weeks 0, 4, and 24]. The age of vaccination was not provided. On an unspecified date, 127 days after last vaccination, the patient developed anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis and scleroderma. The ANCA positive vasculitis event's immune classification was "Classical autoimmune" and scleroderma event's immune classification was innate immune mediated. The event was classified as new-onset adverse event of special interest. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the events of anti-neutrophil cytoplasmic antibody (ANCA) positive vasculitis, scleroderma and ENGERIX. The authors concluded "the safety profile of HBsAg-1018 is similar to that of HBsAg-Eng with vaccine-associated adverse events limited to mild to moderate local and systemic post-injection reactions. There is no evidence for a causal association between HBsAg-1018 and autoimmune or cardiovascular events. Although current hepatitis B vaccines have addressed a medical need in infants and adolescents, there remains a large unmet need in adults. A two dose hepatitis B vaccine with an acceptable safety profile should provide improved seroprotection and a significant public health benefit to adults 18 years of age or older". This is 1 of the 4 valid cases reported in the same literature article.