Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B antigen positive, Immunoglobulin therapy, Vaccination failure, Vertical infection transmission
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a child subject who received Hepatitis B vaccine. Co-suspect products included immunoglobulin antihepatitis b. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and 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 and vertical infection transmission. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included hepatitis b (unknown) and vertical infection transmission (unknown). It was unknown if the investigator considered the vaccination failure, hepatitis b and vertical infection transmission to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Relevant Tests: On unknown date, the patient tested positive for hepatitis B antigen and was found to have a viral load higher or equal to 6.32 x 10E7 IU/mL. Diagnostic results (unless otherwise stated, normal values were not provided). On an unknown date, Hepatitis B antigen result was positive iu/ml.. Additional information was provided: This case was reported in a literature article and it described the occurrence of a possible vaccination failure in an infant of unspecified gender and age who had received unspecified hepatitis B vaccine (manufacturer unknown). The patient had been born on an unspecified date between July 2007 and 2010. The patient's mother had been found to be hepatitis B surface and e antigen positive with a viral load higher or equal to 5 x 10E7 IU/mL during pregnancy. No further information on the patient's concurrent medical conditions, history or concomitant medication was provided. On unspecified date, between July 2007 and 2010, the patient received 3 doses of an unspecified hepatitis B vaccine, the first within 12 hours of birth, the second at 70 days of life and the third from 164 to 245 days of life (dosages unknown; administration routes and sites unspecified; batch numbers not provided). The patient had also received hepatitis B immunoglobulin within 12 hours of birth. The authors reported the patient was appropriately vaccinated. On an unspecified date, an unknown period after the vaccination, the patient tested positive for hepatitis B antigen and was found to have a viral load higher or equal to 6.32 x 10E7 IU/mL. According to the authors this was a vertical transmission. Please note that this case was classified as a possible vaccine failure as the time to onset was not provided. This case was assessed as medically significant due to possible vaccination failure. The patient tested positive for hepatitis B surface antigen and was found to have a viral load higher or equal to 6.32 x 10E7 IU/mL. Treatment was unknown. Outcome was unspecified at the time of reporting. The authors referred to the case as an immunoprophylaxis failure. The authors concluded that "our study shows that, with high rates of adherence, immunoprophylaxis administered according to the current Centers of Disease Control and Prevention guidelines is highly effective for preventing perinatal transmission of Hepatitis B virus from Hepatitis B surface antigen positive mothers, particularly for those who are hepatitis e antigen negative or have a viral load less than 5x10E7 UI/mL. Such women are unlikely to benefit from additional interventions to decrease vertical transmission. Mothers who were Hepatitis B e antigen positive or had a viral of 5x10E7 UI/mL or greater had low but detectable transmission rates. Future studies to evaluate the effectiveness of additional prophylaxis measures, such as late-pregnancy antiviral treatment, are warranted among these high-risk women". This case is 1 of the 5 valid cases reported in the same literature article.