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Vaccination with HepB-CpG vaccine in individuals undergoing immune suppressive drug therapy

Institution:	1. Hepatology Division, Baylor Scott and White Medical Center, Dallas, TX, United States;2. Baylor Scott and White Research Institute, United States;1. Institute of Infection and Global Health, University of Liverpool, Cheshire, UK;2. College of Veterinary Medicine, King Faisal University, Al-Ahsa, Saudi Arabia;3. Avian Research Center, King Faisal University, Al-Ahsa, Saudi Arabia;4. Department of Animal Biotechnology, Madras Veterinary College, Tamil Nadu Veterinary and Animal Sciences University, Chennai, India;1. Microbiology & Immunology, Gifu Pharmaceutical University, Japan;2. Kikuchi Research Center, KM Biologics Co., Ltd, Japan;1. Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA;2. Denver Veterans Affairs Medical Center, Aurora, CO, USA;3. Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA;4. Medical Development and Scientific/Clinical Affairs, Pfizer Vaccines, Collegeville, PA, USA;5. Statistical Research and Data Science Center, Pfizer Inc, New York, NY, USA;6. Patient and Health Impact, Pfizer Inc, Collegeville, PA, USA;7. Patient and Health Impact, Pfizer Inc, New York, NY, USA;8. Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, USA;1. Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN 55902, United States;2. Division of Pediatric Allergy and Immunology, Mayo Clinic, Rochester, MN 55902, United States;1. Programa Associado de Pós-Graduação em Enfermagem UPE/UEPB, Universidade de Pernambuco (UPE), Av. Agamenon Magalhães, s/n, Santo Amaro, Recife, PE 50100-010, Brazil;2. Programa de Pós-Graduação em Saúde Pública, Instituto Aggeu Magalhães, Fiocruz Pernambuco, Av. Professor Moraes Rego, s/n, Cidade Universitária, Recife, PE 50740-465, Brazil;3. Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, Keppel St, London WC1E 7HT, UK;4. Faculdade de Ciências Médicas, Universidade de Pernambuco (UPE), Tv. Jackson Pollock - Santo Amaro, Recife, PE 52171-011, Brazil

Abstract:	BackgroundImmunosuppressed patients are a targeted group for HBV vaccination but suboptimal antibody responses occur when traditional recombinant vaccines are used.MethodsWe tested an FDA approved immune adjuvanted HBV vaccine (HEPLISAV--B® or HepB-CpG) in medically immune suppressed individuals. HepB-CpG was given to 10 patients taking biologic agents or anti-rejection therapy. Each received vaccine at time 0 and week 4 with a third dose at week 12 if anti-HBs remained less than 10 mIU/mL.ResultsSeroprotective anti-HBs developed in 70 % of participants by week 24. Those taking biologic agents responded more rapidly and a third dose was generally needed in those transplanted. By week 24, most taking biologics but only 2 of 6 on anti-rejection treatment had antibody levels exceeding 100 mIU/mL.ConclusionsSeroprotective anti-HBs developed in 70 % with HepB-CpG. Antibody responses were more rapid in those taking biologic agents but a third dose improved antibody responses in transplanted participants.

Keywords:	Antibody to HBsAg Hep-CpG Chronic hepatitis B Biologic treatment Immunosuppressive drugs HEPLISAV-B"} {"#name":"keyword" "$":{"id":"k0035"} "$$":[{"#name":"text" "_":"HepB-CpG CpG"} {"#name":"keyword" "$":{"id":"k0045"} "$$":[{"#name":"text" "_":"vaccine mIU/mL"} {"#name":"keyword" "$":{"id":"k0055"} "$$":[{"#name":"text" "_":"milli international units/milliliter ISDT"} {"#name":"keyword" "$":{"id":"k0065"} "$$":[{"#name":"text" "_":"Immunosuppressive drug therapy HBsAg"} {"#name":"keyword" "$":{"id":"k0075"} "$$":[{"#name":"text" "_":"Hepatitis B surface antigen anti-HBc"} {"#name":"keyword" "$":{"id":"k0085"} "$$":[{"#name":"text" "_":"Antibody to hepatitis B core antigen anti-HBs"} {"#name":"keyword" "$":{"id":"k0095"} "$$":[{"#name":"text" "_":"Antibody to hepatitis B surface antigen TNFI"} {"#name":"keyword" "$":{"id":"k0105"} "$$":[{"#name":"text" "_":"Tumor necrosis factor inhibitor
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