Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 22-year-old female subject who received Hepatitis B vaccine for prophylaxis. Concurrent medical conditions included thalassemia beta (received regularly at least 1 unit of blood monthly with last transfusion 4 weeks prior HBV testing) and hepatitis c (The patient was found positive for HCV by serology). On an unknown date, unknown after receiving Hepatitis B vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included hepatitis b with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included hepatitis b (unknown). The investigator considered that there was a reasonable possibility that the vaccination failure and hepatitis b may have been caused by Hepatitis B vaccine. Relevant Tests: Laboratory tests were performed between June 2014 and September 2015. Anti-HCV and HBsAg were tested using a fourth-generation enzyme linked immunosorbent assay (ELISA) which was based on chemiluminescent microparticle immunoassay (CMIA). The patient's haemoglobin level, mean corpuscular volume (MCV) and alkaline phosphatase (ALP) were measured (results not provided). Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Alanine aminotransferase result was 6 unknown. On an unknown date, Aspartate aminotransferase result was 15 unknown. On an unknown date, Hepatitis B DNA assay result was not found positive unknown. On an unknown date, Hepatitis B surface antigen result was positive unknown. On an unknown date, Hepatitis C virus test result was positive by serology unknown. On an unknown date, Immunology test result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 22-year-old female who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 2 reported in this literature article. The patient was part of the cross-sectional study that aimed to describe the prevalence of both hepatitis B virus (HBV) and hepatitis B virus (HCV) among ß-thalassemia patients  using serology and molecular assays. Total 139 ß-thalassemia patients attending the thalassemia units in three major hospitals were included in the study during the period from June 2014 to September 2015. [In this study, 139 of the patients had been diagnosed as major or intermediate ß-thalassemia, 15 as sickle ß-thalassemia, and 5 as sickle cell anaemia]. The patient had ß-thalassemia. The patient had attended the thalassemia units between June 2014 and September 2015. The patient received regularly at least 1 unit of blood monthly with last transfusion 4 weeks prior to sampling. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient had received unspecified HBV vaccine (administration route and site unspecified, dosage unknown; batch number not provided). [In this study, all 139 patients were vaccinated for HBV (110 were vaccinated at birth and 29 vaccinated in 1994 during treatment]. The age of the vaccination was not provided. On an unspecified date between June 2014 and September 2015, an unknown period after vaccination, the patient's 5 ml of venous blood sample was collected in a sterile plain tube. Anti-HCV and HBsAg were detected using a fourth-generation enzyme linked immunosorbent assay (ELISA) which was based on chemiluminescent microparticle immunoassay (CMIA). The patient was found positive for HBsAg. The patient's haemoglobin level, mean corpuscular volume (MCV) and alkaline phosphatase (ALP) were measured (results not provided). [In this study, the mean haemoglobin level was below normal (normal range less than or equal to 9.5g/dl) as the study group consisted of thalassemia patients]. The patient's aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found to be 15 and 6 respectively. The patient was found positive for HCV by serology. The patient was not found positive for HBV-DNA by PCR. In this study, it was a reported that 1 patient had HBV-HCV coinfection by serology but negative by molecular assays for both viruses. Subsequently the patient diagnosed with hepatitis B virus infection. This case has been considered as suspected vaccination failure being full schedule was unknown. This case has been considered as serious due to suspected vaccination failure. Treatment was unknown. The outcome of the event was not provided. The author did not comment on relationship between the event of hepatitis B infection and unspecified HBV vaccine. The author stated, "our study showed that most of the ß-thalassemia patients (71%) still have immunity against HBV infection (anti-HBs greater than or equal to 10IU/ml) which is high and comparable to healthy individuals as had been reported earlier by our group and others." The author concluded "In conclusion, the prevalence of HCV among ß-thalassemia patients is significantly higher than the normal population. It is recommended to determine HCV infection in thalassemia patients based on the detection of HCV-RNA by PCR and anti-HCV by serology, simultaneously. On the contrary, the study showed low prevalence of HBV. Finally, a follow-up schedule and administration of booster dose of HBV vaccine is strongly recommended for thalassemia patients whose anti-HBs level less than 10IU/mL." The article corresponding to this case is not available for submission due to copyright restriction. Lab Comments: Laboratory tests were performed between June 2014 and September 2015. Anti-HCV and HBsAg were tested using a fourth-generation enzyme linked immunosorbent assay (ELISA) which was based on chemiluminescent microparticle immunoassay (CMIA). The patient's haemoglobin level, mean corpuscular volume (MCV) and alkaline phosphatase (ALP) were measured (results not provided).