Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Vaccinated With One Dose of HEPLISAV-B and Then Received One Dose of ENGERIX-B; HBsAg Negative at POD 177 Post Heart Transplant; HBsAb Titer was 276.7 mIU/mL at Transplant and 267.1 mlU/mL Two Months Post-Transplant; Initial report received on 19-Jun-2025. This report was retrieved from the following publication: A 53-year-old female received one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received one dose of recombinant hepatitis B vaccine ENGERIX-B approximately one year pre-heart transplant. She remained hepatitis b surface antigen (HBsAg) negative postoperative day (POD) 177. Medical history included advanced heart failure due to arrhythmogenic right ventricular cardiomyopathy. No concomitant medications were reported. One year prior to transplant, the patient was vaccinated with one dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available). One year prior to transplant, the patient was vaccinated with the second dose of a hepatitis B vaccine ENGERIX-B (lot number and expiration date not available). On an unknown date, one year after receiving HEPLISAV-B, the patient received a heart from a donor who was HBsAg negative, hepatitis B core antibody (HBcAB) negative, and hepatitis B virus (HBV) nucleic acid test (NAT) positive. The patient was immune to HBV with a hepatitis B surface antibody (HBsAB) titer of 276.7 mIU/mL at the time of transplant. Of note, the donor was also hepatitis C (HCV) NAT positive for which patient completed a course of sofosbuvir/velpatasvir 400/100 mg 1 tablet by mouth daily for 12 weeks per institutional protocol. She also received entecavir 0.5 mg by mouth daily beginning on POD 2 for an anticipated duration of 1 year and monitoring plans for HBsAg monthly. Two months post-transplant, the patient remained immune to HBV with an HBsAB titer of 267.1 mIU/mL. At POD 121 the patient remained HBsAg negative. At POD 177 she had normal liver function tests. On an unknown date, the patient had a stable allograft function. On transthoracic echocardiograph, the patient had a calculated ejection fraction of 57.6% No additional information was reported. Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Arrhythmogenic right ventricular cardiomyopathy; Heart failure (Due to Arrhythmogenic Right Ventricular Cardiomyopathy)
Engerix b
Test Name: Ejection Fraction; Test Name: Ejection Fraction; Test Result: 57.6 %; Result Unstructured Data: Measured by transthoracic echocardiography; Test Name: HBsAb Titer; Result Unstructured Data: Immune to HBV; Test Name: HBsAb Titer; Result Unstructured Data: Immune to HBV