Sex: M
Vaccine: HEP
Symptoms: Vaccination failure, Viraemia
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 28-year-old male subject who received Hepatitis B vaccine. Concurrent medical conditions included blood donor. In 2008, unknown after receiving Hepatitis B vaccine, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included hepatitis B in 2008 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 (recovered/resolved). It was unknown if the investigator considered the vaccination failure and hepatitis B to be related to Hepatitis B vaccine. Relevant Tests: The patient's initial blood screening was negative for hepatitis B surface antigen and hepatitis B core antibodies; hepatitis B surface antibodies level at this point was 33 U/L and the hepatitis B DNA level was 27 IU/ml. On follow-up, the viraemia was estimated to have lasted from 72 to 107 days and the patient was found to have developed hepatitis B core antibodies after 107 days. Hepatitis B surface antigen level during the follow up period was 72 and the alanine aminotransferase level was 3-12 U/L. The viral genotype was identified as 6D, 2A2 with 8 clones sequenced and sY134H and sT143A substitutions on S protein. Diagnostic results (unless otherwise stated, normal values were not provided): In 2008, Alanine aminotransferase result was 3-12 U/L, Hepatitis B DNA assay result was 27 IU/ml, Hepatitis B core antibody result was Negative absent, Hepatitis B core antibody result was Positive absent, Hepatitis B surface antibody result was 33 IU/L. Hepatitis B surface antigen result was 72 absent and Hepatitis B surface antigen result was Negative absent. Additional information received: This case was reported in a literature article and it described the occurrence of a possible vaccination failure in a 28-year-old male patient, who had received unspecified hepatitis B vaccines (manufacturers unknown). The patient was a blood donor. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received an unknown number of doses of an unspecified hepatitis B vaccines (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date in 2008, an unknown period after the vaccinations, a patient's blood donation was screened and he was found to be positive for hepatitis B DNA but negative for hepatitis surface antigen and hepatitis B core antibodies. According to the authors this indicated that a subclinical infection had developed and resolved. Further follow-up showed transiently low levels of hepatitis B surface antigens whereas hepatitis B surface antibodies remained reactive: as well as an increase in hepatitis B surface antibodies that correspond to the disappearance of hepatitis B surface antigens. Please note that this case was classified as a possible vaccine failure as the number of vaccine doses received by the patient was not specified, the time to onset was unknown and no clinical symptoms were reported. The patient's initial blood screening was negative for hepatitis B surface antigen and hepatitis B core antibodies; hepatitis B surface antibodies level at this point was 33 U/L and the hepatitis B DNA level was 27 IU/ml. On follow-up, the viraemia was estimated to have lasted from 72 to 107 days and the patient was found to have developed hepatitis B core antibodies after 107 days. Hepatitis B surface antigen level during the follow up period was 72 and the alanine aminotransferase level was 3-12 U/L. The viral genotype was identified as 6D, 2A2 with 8 clones sequenced and sY134H and sT143A substitutions on S protein. Treatment was unknown. Outcome of the acute viral infection was resolution. Outcome of the rest of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccines and the events. The authors concluded that "this study showed a higher than expected rate of hepatitis B infection with the use of triplex nucleic acid testing, mainly in donors who had been vaccinated against hepatitis B virus and who would not have been identified by routine screening for hepatitis B surface antigen or hepatitis B core antibodies. However, these acute hepatitis B viral infections rapidly resolved and are of inconsequential clinical significance, but their potential for transmission remains unresolved. Our findings show the efficacy of the hepatitis B vaccine for the prevention of clinical disease but not infection, and the cost of interdicting donations that contain hepatitis B virus DNA from seronegative donors is high in the face of unknown benefit. Because of the high cost of introducing new screening assays for blood donors and the inability to document cost-effectiveness similar to that of other medical interventions, the continued development of new tests either to replace older tests or to detect newly identified agents is in question". This case is 1 of the 6 valid cases reported in the same literature article (see case US2015GSK060124).