Sex: U
Vaccine: HEP
Symptoms: Chronic hepatitis B, Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: Suspected vaccination failure; Chronic Hepatitis B infection; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult patient who received Hepatitis B vaccine for prophylaxis. (Johansson ED, Nunez M. Acute Hepatitis B Surge: Opioid Epidemic Implication and Management Challenges. Open Forum Infectious Diseases 2020; 7(6):  .)  DOI:10.1093/ofid/ofaa190.  Concurrent medical conditions included hiv infection.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and chronic hepatitis b (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and chronic hepatitis b were unknown.   It was unknown if the reporter considered the vaccination failure and chronic hepatitis b to be related to Hepatitis B vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure, in a patient more than or equal to 19-year-old of unspecified gender, who was vaccinated with Unspecified Hepatitis B vaccine (manufacturer unknown) for prophylaxis.   The patient was a part of a retrospective study whose primary objective was to examine the number of patients with acute hepatitis B virus (HBV) infection managed at a campus from 1st January 2015 to 31st December 2018, as well as their characteristics and serological and clinical outcomes. A secondary objective was to evaluate the diagnosis and treatment at the institution, based on national standards. No information on patient medical or family history or concurrent condition or concomitant medication was reported.  On an unknown date, the patient received unspecified Hepatitis B vaccination (administration site unspecified, dose number unknown; batch number not provided) upon diagnosis of HIV. The age at vaccination was not provided. [In this study, out of the 5 patients born after 1991, when the recommendation for universal HBV child vaccination was issued, only 1 confirmed having been vaccinated]. On an unspecified date 1st January 2015 to 31st December 2018, an unknown period after vaccination, the patient was noted with positive hepatitis B surface antigen (HBsAg). The patient had either jaundice or elevated alanine aminotransferase (ALT) levels more than 100 IU/L without alternative explanation; either an acute illness with a discrete onset of any sign or symptom consistent with acute viral hepatitis (eg, fever, headache, malaise, anorexia, nausea, vomiting, diarrhea, and abdominal pain) without alternative explanation or a documented negative HBsAg within the prior 6 months or a positive hepatitis B core (HBc) IgM antibody. The patient was diagnosed with acute Hepatitis B infection initially and later developed chronic HBV infection. [In this study, defined a case of acute hepatitis B with the following criteria: (1) a positive hepatitis B surface antigen (HBsAg) and (2) either jaundice or elevated alanine aminotransferase (ALT) levels more than 100 IU/L without alternative explanation and (3) either (a) an acute illness with a discrete onset of any sign or symptom consistent with acute viral hepatitis (eg, fever, headache, malaise, anorexia, nausea, vomiting, diarrhea, and abdominal pain) without alternative explanation or (b) a documented negative HBsAg within the prior 6 months or (c) a positive hepatitis B core (HBc) IgM antibody. Outcome measures included clinical course, use of anti-HBV treatment, and progression to chronic infection, using the American Association for the Study of Liver Diseases (AASLD) criteria. A protracted-severe course was defined as either more than 4 weeks of an elevated INR (more than or equal to 1.5) or total bilirubin more than 3 mg/dL (or direct more than 1.5 mg/dL) or clinical evidence of encephalopathy or ascites. The lack of these criteria defined an uncomplicated course. Following AASLD guidelines, indications for anti-HBV treatment included protracted severe course, and acute liver failure was defined as an elevated INR (more than or equal to 1.5) with evidence of altered sensorium in a patient without preexisting cirrhosis. HBsAg positivity for at least 6 months after the initial HBsAg positive result defined chronic HBV infection. 36 cases of acute HBV were identified during the study period, 8 in 2015-2016 and 28 in 2017-2018. A history of intravenous drug use (IVDU) was identified in 8 patients, and all of these had acute hepatitis B in 2017 and 2018. Two patients reported vaccination against HBV several years before the infection. One of them was vaccinated upon diagnosis of HIV infection. More than half of patients did not follow up after diagnosis of acute HBV, and therefore their clearance status could not be determined. Seventeen patients had follow-up HBsAg testing, and 1 developed chronic HBV infection. This patient was co-infected with HIV, and his antiretroviral regimen included lamivudine as the only drug active against HBV. One patient with Crohn's disease, who was on treatment with mesalamine at the time of the infection, cleared the HBsAg by the 14th month after acute illness]. The case was considered as suspected vaccination failure being dosing schedule and time to onset unknown. The case was considered as serious due to suspected vaccination failure. Treatment was unknown. Outcome was not reported. The authors commented "Our data suggest that IVDU has contributed to an increase in acute hepatitis B cases in our community at least since 2017. This coincides with a national uptrend in drug abuse, an epidemic ongoing for more than a decade. In the HBV vaccination efforts, new ways of identifying individuals at high risk and additional venues to deliver the vaccine could be considered. On this regard, in our study one-third of the patients had used the hospital emergency room within the prior year, and more than half had psychiatric disease. Limited vaccine effectiveness constitutes another barrier in the fight against HBV. Thus, 2 of our patients became infected despite prior vaccination, 1 of whom was HIV-positive. As HIV infection is not only a well-recognized risk factor for poorer response to the HBV vaccine but also for developing chronic infection, including tenofovir as part of the HIV treatment can confer additional protection. The patient who developed chronic HBV was infected with HIV, an association that is well recognized, with an estimated risk up to 6 times higher than non-HIV hosts. Interestingly, we observed spontaneous HBsAg clearance after 6 months in 1 patient with Crohn's disease. Itis unclear if this delay was related to Crohn's in the absence of immunosuppressive therapy.".   The authors concluded "In summary, our study confirms that the IVDU epidemic is implicated in the surge of HBV cases in our community, and it highlights the importance of additional efforts for vaccination targeting at-risk individuals at all possible levels of care. We identified opportunities to inform and prepare our health care providers while the opioid epidemic continues in order to better align the diagnosis and management of acute HBV with national guidelines". This article is not available for regulatory submission due to copyright restriction.