Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase normal, Hepatitis B, Hepatitis B DNA assay positive, Hepatitis B core antibody negative, Hepatitis B surface antibody
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 37-year-old female subject who received Hepatitis B vaccine. Concurrent medical conditions included blood donor and hepatitis B exposure. In 2008, 27 years after having Hepatitis B vaccine, the subject developed vaccination failure. Serious criteria included 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: On an unspecified date in 2008, approximately 27 years after the vaccination, a patient's blood donation was screened and she was found to be positive for hepatitis B DNA but negative for hepatitis surface antigen and hepatitis B core antibodies. Her hepatitis B surface antibody level was determined to be non-immune. 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 3 IU/L and the hepatitis B DNA level was 86 IU/ml. On follow-up, the viraemia was estimated to have lasted from 44 to 70 days and the patient was found to have developed hepatitis B core antibodies after 70 days. Hepatitis B surface antibody level was 20 IU/L which, according to the authors, indicated an anamnestic response. Her alanine aminotransferase level was 3-8 U/L at that time. The viral genotype was identified as A2 with 11 clones sequences and G102D and T134A substitutions on S protein. The authors commented that the patient and her partner's sequences of the presurface and surface regions of the hepatitis B surface antigen gene were nearly identical at nucleotide level and at the amino acid level. Diagnostic results (unless otherwise stated, normal values were not provided): In 2008, Alanine aminotransferase result was 3 to 8 IU/L. Hepatitis B DNA assay result was 86 IU/ml, Hepatitis B core antibody result was Negative absent. Hepatitis B core antibody result was Positive absent, Hepatitis B surface antibody result was 20 IU/L, Hepatitis B surface antibody result was 3 IU/L 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 37-year-old female patient, who had received an unspecified plasma-derived hepatitis B vaccine (manufacturer unknown). The patient was a blood donor whose partner (38-year-old male) was unvaccinated and later found to have a hepatitis B viral DNA level of 3.6 x 108IU/mL and to be negative for hepatitis B surface antibodies. His viral genotype was A2 with 10 clones sequenced (no substitutions on S protein reported). His alanine aminotransferase level was 17 U/L. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates in 1981, the patient had received an unspecified plasma-derived hepatitis B vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date in 2008, approximately 27 years after the vaccination, a patient's blood donation was screened and she was found to be positive for hepatitis B DNA but negative for hepatitis surface antigen and hepatitis B core antibodies. Her hepatitis B surface antibody level was determined to be non-immune. According to the authors this indicated that a subclinical infection had developed and resolved. The authors believed that the patient had been infected via sexual transmission from her partner as their sequences of the presurface and surface regions of the hepatitis B surface antigen gene were nearly identical at nucleotide and amino acid level. Please note that this case was classified as a possible vaccine failure as the patient did not received the full vaccination schedule 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 3 IU/L and the hepatitis B DNA level was 86 IU/ml. On follow-up, the viraemia was estimated to have lasted from 44 to 70 days and the patient was found to have developed hepatitis B core antibodies after 70 days. Hepatitis B surface antibody level was 20 IU/L which, according to the authors, indicated an anamnestic response. Her alanine aminotransferase level was 3-8 U/L at that time. The viral genotype was identified as A2 with 11 clones sequences and G102D and T134A substitutions on S protein. The authors commented that the patient and her partner's sequences of the presurface and surface regions of the hepatitis B surface antigen were nearly identical at nucleotide level and at the amino acid level. 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).