Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B, Hepatitis B DNA increased, Inappropriate schedule of product administration, Vertical infection transmission
Clinical narrative: hepatitis B infection; Vertical infection transmission; received the first dose of vaccine at 45 days of age; This serious case was reported in a literature article and described the occurrence of hepatitis b in a infant patient who received Hepatitis B vaccine for prophylaxis. Literature Reference.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Family history included hiv infection (Mother) and viral hepatitis b (Mother).   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced hepatitis b (Verbatim: hepatitis B infection) (serious criteria GSK medically significant), vertical infection transmission (Verbatim: Vertical infection transmission) and inappropriate schedule of vaccine administered (Verbatim: received the first dose of vaccine at 45 days of age).  The outcome of the hepatitis b and vertical infection transmission were not reported and the outcome of the inappropriate schedule of vaccine administered was unknown.   The reporter considered the hepatitis b, vertical infection transmission and inappropriate schedule of vaccine administered to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.     The company considered the hepatitis b, vertical infection transmission and inappropriate schedule of vaccine administered to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.   Additional Information: GSK receipt Date: 11 Sep 2023 This case correspondence to one of the two infant who had perinatal transmission as mentioned in the article. To describe the anti-hepatitis B virus (HBV) efficacy, HBeAg serologic changes, HBV perinatal transmission, and safety in pregnant women who are living with human immunodeficiency virus (HIV) and HBV coinfection who were randomized to various antiretroviral therapy (ART) regimens. The trial was a multicenter randomized trial for ART pregnant women with HIV infection. Women with HIV and HBV co-infection at 14 or more weeks of gestation were randomized to one of three ART arms. Antiretroviral therapy in group 1 included no HBV-active therapy and was comprised of ZDV(zidovudine) and intrapartum nevirapine. All women in group 1 also received 1 week of daily FTC and TDF. Antiretroviral therapy in group 2 included single-active HBV therapy and was comprised of 3TC, ZDV, and LPV/r (Lopinavir/ritonavir); 3TC (lamivudine) is the single HBV-active agent. Antiretroviral therapy in group 3 included dual-active HBV therapy and was comprised of TDF(tenofovir disoproxil fumarate), FTC (emtricitabine), and LPV/r; TDF and FTC are the two HBV-active agents. The primary outcome measure was HBV viral load (log10 international units/mL) change from baseline (enrollment) to 8 weeks. Safety assessments included ALT, aspartate aminotransferase, and anemia (Hgb less than 10 g/dL). Total of 3,543 women, 3.9% were HBsAg-positive; 42 were randomized to group 1, 48 to group 2, and 48 to group 3.  The patient's mother was from group 2 (LPV/r+3TC+ZDV arm). The patient's mother HBV viral load at delivery was 556 international units/mL. The patient received first dose of vaccine at 45 days of age. The patient delivery HBV DNA was 556 international units/mL, gestational age at enrollment was 22.49 weeks of gestation and time on therapy at date of delivery of 14.6 weeks.; Sender's Comments:  US-GSK-US2023GSK125859:same article