Sex: M
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B DNA assay positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen positive, Vaccination failure
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 50-year-old male patient who received Hepatitis B vaccine for prophylaxis. The patient's past medical history included end stage renal disease (On unspecified date in 2012, the patient had an initiated of hemodialysis), hepatitis b, viral hepatitis c, hiv infection and hemodialysis (On unspecified date in between July 2013 and August 2015).   In August 2015, the patient received Hepatitis B vaccine. On an unknown date, less than 2 months after receiving 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.  Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 50-year-old male patient who was vaccinated with unspecified Hepatitis B Virus (HBV) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to case 3 of table 1 reported in this literature article. The patient was identified from the medical history receiving hemodialysis and human immunodeficiency virus and hepatitis C virus coinfections. On unspecified date in 2012, the patient had an initiated of hemodialysis. At hemodialysis initiation at hospital A's outpatient clinic in 2012, his HBV serologic test results suggested a possible past resolved HBV infection with positive total anti-HBc (First known positive total anti-HBc on June 2012), positive anti-HBs ((before HBsAg seroconversion) October 2013), and negative HBsAg  (that First known negative HBsAg (June 2012); Last known negative HBsAg (July 2015). In December 2013, the patient lost HBV immunity and became anti-HBs negative while remaining HBsAg negative.  No information on patient's family history or concomitant condition was provided. On unspecified date in between July 2013 and August 2015, the patient was on hemodialysis (HD), the patient was on likely infectious and not on HBV isolation. On unspecified date in between December 2013 and June 2015, the patient potential exposure period was travel history. On unspecified date in August 2015, 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 an unspecified date in August 2015, unknown period after vaccination, the patient s HBV Isolation was initiated. During hospitalization for hemodialysis (2015), the patient had an HBV serology, which showed First known positive HBsAg (August 2015); First known negative anti- HBs (December 2015); Last known negative anti- HBs (August 2015). On an unspecified August 2015, the patient's HBV serology showed that the 3,945,000 copies/m. On an unspecified March 2013, the patient's Highest known ALT/AST: 241/148. Repeat HBV testing for inpatient dialysis during an August 2015 hospitalization showed a weakly-reactive HBsAg testing by platform such as abbott in January 2016: positive; Siemens Advia Centaur XP: HBs assay: weakly-positive (August 2015); HBsII assay: positive (December 2015) and HBs assay: negative (June 2015 and September 2015), However, subsequent HBsAg testing on VITROS (August 2015 and January 2016) platform was negative, while HBV DNA levels were 3,945,459 IU/mL. From this point onward, HBV isolation precautions were initiated for this patient. HBsAg mutation was suspected as a possible explanation for the negative HBsAg result with concurrent high HBV DNA levels. The patient did not performed other HBV testing's: such as HBV genotype (H) and HBV molecular sequencing. Testing at CDC revealed positive HBsAg with Abbott ARCHITECT platform and negative HBsAg with VITROS platform, suggesting that it was a presumed HBsAg mutant strain, although attempts to sequence HBV DNA were unsuccessful due to low HBV DNA levels (500 copies/mL) at that time. The investigation launched in September 2015 revealed that the case patient received dialysis at 2 out-of-state hemodialysis clinics A and B in June 2015. At out-of state hemodialysis clinic A, he was dialyzed in an HBV isolation room because of serologic test results demonstrating potential HBV infectivity (hepatitis B e antigen positive and HBsAg negative). However, he was not dialyzed in an HBV isolation room at out-of-state hemodialysis clinic B because he tested negative for HBsAg (on Siemens Advia Centaur XP platform, using Siemens HBs assay, not the newer HBsII assay). Screening of potentially exposed hemodialysis patients did not reveal new HBV infections. The case patient was treated for HBV infection and his last HBV DNA levels were very low. He continues to receive hemodialysis with HBV isolation precautions in place. This case considered as suspected vaccination failure due to onset time was unknown. This case has been considered as serious due to suspected vaccination failure. The author commented, "To our knowledge, there has been no documented hemodialysis-related transmission of a mutant strain of HBV. Our patient had serologic evidence of previous HBV infection (total anti-HBc positive) before initiation of hemodialysis; therefore, their HBsAg seroconversions could have been the result of reactivation ofthan new infection." 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: HBsAg testing by platform such as abbott in January 2016: positive; Siemens Advia Centaur XP: HBs assay: weakly-positive (August 2015); HBsII assay: positive (December 2015) and HBs assay: negative (June 2015 and September 2015), However, subsequent HBsAg testing on VITROS (August 2015 and January 2016) platform was negative, while HBV DNA levels were 3,945,459 IU/mL.  From this point onward, HBV isolation precautions were initiated for this patient. HBsAg mutation was suspected as a possible explanation for the negative HBsAg result with concurrent high HBV DNA levels. The patient did not performed other HBV testing's: such as HBV genotype (H) and HBV molecular sequencing. Testing at CDC revealed positive HBsAg with Abbott ARCHITECT platform and negative HBsAg with VITROS platform, suggesting that it was a presumed HBsAg mutant strain, although attempts to sequence HBV DNA were unsuccessful due to low HBV DNA levels (500 copies/mL) at that time. The investigation launched in September 2015 revealed that the case patient received dialysis at 2 out-of-state hemodialysis clinics A and B in June 2015. At out-of state hemodialysis clinic A, he was dialyzed in an HBV isolation room because of serologic test results demonstrating potential HBV infectivity (hepatitis B e antigen positive and HBsAg negative). However, he was not dialyzed in an HBV isolation room at out-of-state hemodialysis clinic B because he tested negative for HBsAg (on Siemens Advia Centaur XP platform, using Siemens HBs assay, not the newer HBsII assay).