Sex: M
Vaccine: HEP, HEP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood immunoglobulin M normal, Condition aggravated, Death
Clinical narrative: Suspected vaccination failure; Hepatitis B; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 80-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   The patient's past medical history included hemodialysis (in 2008, the patient had an initiated of hemodialysis). Concurrent medical conditions included end stage renal disease, diabetes mellitus, lymphoma (status post chemotherapy in 2009), coronary artery disease and cirrhosis of liver without mention of alcohol.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and hepatitis b (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and hepatitis b were unknown.   It was unknown if the reporter considered the vaccination failure and hepatitis b to be related to Hepatitis B vaccine and Hepatitis B vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 80-year-old male patient who was vaccinated with unspecified Hepatitis B Virus (HBV) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 1 of table 1 reported in this literature article. The patient had medical history significant for end-stage renal disease ESRD; diabetes mellitus; lymphoma (status post chemotherapy in 2009); coronary artery disease. On unspecified date in 2008, the patient had an initiated of hemodialysis. At the time of initiation, the patient was considered HBV- susceptible (anti-HBs and HBsAg negative) but failed to respond to a full HBV vaccination series. In 2009, HBV testing confirmed he was HBV susceptible. No information on patient's family history or concomitant condition was provided. On unspecified date in 2010, the patient had received unspecified Hepatitis B Virus (HBV) vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On unspecified date, unknown period after vaccination and in between during this period July 2011 and January 2014, the patient was on hemodialysis (HD), the patient was on likely infectious and not on HBV isolation.  On unspecified date in between 2011 and 2014, the patient potential exposure period was elsewhere (i.e travel history). The patient had an HBV serology, which showed that First known negative HBsAg (July 2010); Last known negative HBsAg (July 2012); First known positive HBsAg (January 2014); First known negative anti- HBs (December 2010); Last known negative anti- HBs (July 2011); First known positive anti- HBs (before HBsAg seroconversion) January 2012 (negative in January 2014); First known positive total anti-HBc ( February 2014 (tested negative June 2010). In January 2012, the case patient was anti-HBs positive and HBsAg negative and considered HBV immune.  On unspecified date in 2013, the patient had hospitalization due to multiple invasive procedures including HD, surgery. On an unspecified date in January 2014, the patient had an HBV Isolation precautions were implemented. Further HBV testing revealed that he had chronic HBV infection (negative immunoglobulin M [IgM], anti-HBc, positive total anti-HBc (February 2014 (tested negative June 2010), positive hepatitis B e antigen, First known positive HBsAg (January 2014). On an unspecified February 2014, the patient's HBV serology showed that the patient had a high HBV DNA levels of 593,045,000 copies/mL [UltraQuant] on and on unspecified date in 2014, the patient had an 101,898,000 IU/mL [AmpliPrep/cobas-Roche]. On an unspecified May 2013, the patient's highest known ALT/AST: 19/54. The patient had also done HBsAg testing by platform such in January 2014: positive; Siemens Advia Centaur XP: not tested; VITROS in March 2014: positive. Given the unusual serologic picture of HBsAg seroconversion several months after the initial laboratory evidence of exposure to HBV infection (newly anti-HBs positive in January 2012) paired with high HBV DNA levels, infection with an HBV mutant strain was suspected. Sequencing of HBV DNA revealed a genotype H infection with a sP127L mutation in the "a" determinant region. The patient also had other HBV testing's which showed that the sequencing of HBV DNA revealed a genotype H infection with a sp127l mutation in the "a" determinant region. The screening of potentially exposed hemodialysis patient in 2014 did not reveal new HBV infections. The source of HBV infection was not discovered.  The case patient died in 2014 from complications of ESRD and non-alcoholic related cirrhosis. It was unknown whether his death was related to HBV infection.  This case considered as suspected vaccination failure due to onset of time was unknown. This case has been considered as serious due to suspected vaccination failure. The author commented, "It was unknown whether his death was related to HBV infection. To our knowledge, there has been no documented hemodialysis-related transmission of a mutant strain of HBV." The author concluded "Mutant HBV infections should be suspected in patients who test HBsAg negative and concurrently test positive for HBV DNA at high levels. Dialysis providers should consider using HBsAg assays that can also detect mutant HBV strains for routine HBV testing." This is 1 of the 2 valid cases reported in this literature article.      Lab Comments: The patient had also done HBsAg testing by platform in January 2014: positive; Siemens Advia Centaur XP: not tested; VITROS in March 2014: positive. Given the unusual serologic picture of HBsAg seroconversion several months after the initial laboratory evidence of exposure to HBV infection (newly anti-HBs positive in January 2012) paired with high HBV DNA levels, infection with an HBV mutant strain was suspected. Sequencing of HBV DNA revealed a genotype H infection with a sP127L mutation in the "a" determinant region. The patient also had other HBV testing's which showed that the sequencing of HBV DNA revealed a genotype H infection with a sp127l mutation in the "a" determinant region.