Sex: M
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B virus test positive, Hepatocellular carcinoma, High risk sexual behaviour, Human immunodeficiency virus transmission
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 adult male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown 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 provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a male patient aged between 16 and 60 years old who was vaccinated with Hepatitis B virus vaccine (manufacturer unknown) for prophylaxis.  The patient was a part of the cross-sectional study that objective was to investigate the prevalence and factors associated with polymerase chain reaction (PCR) diagnosed hepatitis B virus (HBV) among men who have sex with men (MSM) and transgender women (TGW) living with or at risk for HIV in. [It was hypothesized that HIV infections would be associated with increased odds of HBV infection in MSM and TGW. The cohort study used respondent driven sampling (RDS) to recruit MSM and TGW between March 2013 and February 2020 and between April 2014 and May 2018. Eligibility criteria included the following: (1) assigned male sex at birth, (2) history of insertive or receptive anal intercourse with another man in the past 12 months, (3) adulthood (aged 16 years or older and 18 years or older), (4) possession of a valid coupon. Exclusion critiera included those who declined HIV counseling and testing. In addition to these criteria, participants included in this cross-sectional study had an enrollment visit at the clinics before June 2015, an HIV diagnostic result, and plasma for retrospective HBV screening. HBsAg screening was completed using the Genescreen HBsAg 3.0 EIA assay (Laboratories). To confirm the presence of HBV and to quantify DNA, it was performed in vitro PCR using the Abbott Real-Time HBV assay. Participants who tested positive for HBsAg with detectable HBV DNA were considered HBV-infected. Whole blood was tested for HIV using a parallel series of rapid tests. In cases of discordance, a 3rd rapid test was used to confirm or exclude HIV infection as outlined by the parallel testing algorithm for at-risk individuals. For participants living with HIV, HIV RNA was quantified using the Ampliprep/COBAS TaqMan HIV-1 Test and CD4 counts using the Partec CyFlow Counter. Voided urine and rectal swabs were tested for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) using the Aptima Combo 2 CT/ NG Assay. All participants testing positive for HIV or other STIs were offered appropriate treatment regardless of CD4 count]. The patient assigned male sex at birth. The patient had history of insertive or receptive anal intercourse with another man in the past 12 months. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified Hepatitis B virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided.   On an unspecified date, between March 2013 and June 2015, an unknown period after the vaccination, the patient's blood sample was collected for in vitro PCR using the Abbott Real-Time HBV assay. Whole blood was tested for HIV using a parallel series of rapid test (result not provided). Voided urine and rectal swab was tested for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) using the Aptima Combo 2 CT/ NG Assay (result not provided). The patient was found Hepatitis B virus positive. The patient was considered HBV-infected.   [Of the 771 participants enrolled from March 2013 to June 2015, 717 had real-time HIV and retrospective HBV testing results available and were included in study. Out of these, 438 (61%) were HIV-infected and 69 (10%) were HBV-infected, including 41 (6%) with HIV-HBV co-infection. HIV-HBV co-infected participants had a lower median CD4 T cell counts of 345 cells/cubic mm than HIV mono-infected participants, 425 cells/cubic mm. Similarly, HIV-HBV co-infected participants had a higher median HIV RNA viral load of 4.7 log10 copies/mL than HIV mono-infected participants, 4.2 log10 copies/mL. The median age of participants included in these analyses was 25 years. Sixty-two percent of participants identified as bisexual and 75% engaged in any receptive sex. Eighty-seven percent had never married, and 93% had at least a secondary school (high school equivalent) education. Regarding health services, 63% were willing to access care but only 5% self-reported HBV vaccination. Compared to HIV-uninfected persons, HIV-infected persons were more likely to be older, married, and engaged in any receptive sex. However, HIV-infected MSM and TGW were less willing to access health care services. The prevalence of HBV in the study population did not differ between those living with or without HIV (9% vs. 10%, respectively). After adjusting for potential confounders, HIV was not associated with HBV prevalence. Those who had not used a condom during last anal sex were twice as likely to be infected with HBV as compared to those who had used a condom in the unadjusted analysis. In the multivariable analysis, condomless sex at last anal sex remained an independent factor and was associated with a two-fold increased odds of HBV infection as compared to those who used condoms. Although not significant, self-reported homosexual orientation independently trended towards an association with HBV infection. Age, marital status, willingness to access healthcare services, HBV vaccination, sexual position, ever condomless sex, concurrent sexual partners, prevalent bacterial STIs, and vaginal sex in the last year were not associated with HBV. After comparing those included and excluded from the analyses, the retained individuals were less willing to access health care services and more likely to self-identify as homosexual as compared to bisexual].  This case has been considered as suspected vaccination failure being the time to onset and the 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 reported.  The authors commented, "The HBV prevalence of 10% observed among MSM and TGW in our study was comparable to those reported by cross-sectional studies of MSM, (10%) and  (11%) but higher than (5%). Our estimates were slightly higher than previous estimates of (4 to 8%) with unknown sexual orientation. However, our results were lower than those from a study conducted where the reported HBV prevalence among MSM was 18%. In contrast to our hypothesis, the prevalence of HBV was not higher among MSM and TGW living with HIV. This finding is consistent with a prior systematic review that reported an 8% pooled prevalence of HBsAg that did not differ by HIV among a population of adults. Although our study did not find a significant association between HIV and HBV prevalence, it offers some insight into how the use of condoms and sexual activities may affect HBV infection. In our cohort, condom usage has been suboptimal and this is a population known to have a high burden of human immunodeficiency virus, anorectal STIs, and sexual risk practices. Consistent with our findings, the HIV Cohort study reported condomless sex increased the hazard of HBV acquisition 2-fold among those living with HIV independent of TDF-containing regimens. In our study, sexual positioning was not associated with HBV infection. Despite sexual position or sexual orientation, culturally acceptable methods to communicate the benefits of condoms during anal sex for unvaccinated individuals could reduce the risk of HBV and associated morbidities such as end-stage liver disease (ESLD) and hepatocellular carcinoma (HCC). Self-reported vaccination coverage among MSM and TGW was 5% and insufficient in preventing active HBV infection. Routine childhood HBV vaccination was only enacted 15 years ago as part of the expanded immunization program and possibly explains the low vaccination coverage. Most high-income countries with effective vaccination programs have much lower estimates of active HBV. A nationwide, multicenter prospective study of HIV-infected MSM reported active HBV prevalence as 2%, cleared HBV as 27% and occult HBV as 8%. Our study had some limitations. With relatively small prevalence estimates, the multivariable model was not sufficiently powered to detect independent associations between HBV infection and known demographic and behavioral factors. However, most associations between sexual behaviors such as homosexual orientation and exclusively male partners with HBV infection aligned with the direction of the study hypothesis. Although, because more MSM who self-identified as homosexual were retained in our analyses, our prevalence estimates may have been an overestimate because of enrichment of those engaging in high risk sexual practices. HBV vaccination was self-reported as ever receiving and did not specify the number of doses. Additionally, it was unclear who had been exposed to HBV from vaccination versus a prior infection, as testing for HBV surface antibody was unavailable due to limited sample volume. Due to uncertainty regarding participants' past exposure to specific ART regimens, we were unable to assess whether HBV prevalence was lower among those living with HIV and exposed to TDF-containing regimens. The temporality of associations between HIV and HBV could not be determined because of the cross-sectional study design. Lastly, MSM and TGW originated from two cities and results from this study may not be generalizable to other regions." The authors concluded, "HBV prevalence was moderately high and comparable to other studies of MSM but did not differ by HIV status. Recent condomless anal intercourse elevated the risk of HBV, reinforcing the need to increase communication and education on HBV and its potential long-term complications. Further studies are needed to confirm whether the attenuated HBV prevalence among MSM and TGW living with HIV was the result of TDF containing ART regimens with anti-HBV activity." Comment: As determined causality' from unknown' to No'  for the following event hepatitis B infection and vaccination failure due to Insufficient information.