title: Safety and efficacy of hepatitis B surface antigen-pulsed dendritic cells in human volunteers.
abstract: Hepatitis B surface antigen (HBsAg)-pulsed murine spleen dendritic cells (DCs) have shown tremendous therapeutic potentials in chronic hepatitis B virus (HBV) carriers however, there has been no study regarding the feasibility of using HBsAg-pulsed DCs in human. Five human healthy volunteers with no apparent concomitant diseases were enrolled in this study. DCs were enriched from peripheral blood of each volunteer in endotoxin-free and sterilized conditions. HBsAg-pulsed DCs were prepared by culturing DCs with a commercial-available human grade vaccine containing HBsAg. After assessing the expression of HLA DR and CD86 on HBsAg-pulsed DCs, 5 million HBsAg-pulsed DCs were injected intradermally, once, to each volunteer. The volunteers were serially observed for safety and efficacy of administration of HBsAg-pulsed DCs. No evidence of physical, biochemical, and immunological abnormalities were documented in any volunteer during the next 28 days following administration of HBsAg-pulsed DCs. A single administration of HBsAg-pulsed DCs resulted in upregulation of anti-HBs in two anti-HBs(+) volunteers. Moreover, anti-HBs were detected in two anti-HBs(-) volunteer, 2 weeks after administration of HBsAg-pulsed DCs. This study provides the scientific and ethical basis for using HBsAg-pulsed DCs for therapeutic and prophylactic purposes in patients with chronic hepatitis B and non-responders to hepatitis B vaccine, respectively.
authors.affiliation: Third Department of Internal Medicine, Ehime University School of Medicine, Shigenobu-Cho, Ehime 79-0295, Japan.
authors.forename: Sk. Md.
authors.initials: SM
authors.lastname: Fazle Akbar
authors.forename: Shinya
authors.initials: S
authors.lastname: Furukawa
authors.forename: Morikazu
authors.initials: M
authors.lastname: Onji
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Murata
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Niya
authors.forename: Sakiko
authors.initials: S
authors.lastname: Kanno
authors.forename: Hidehiro
authors.initials: H
authors.lastname: Murakami
authors.forename: Norio
authors.initials: N
authors.lastname: Horiike