Autologus dendritic cell vaccine for chronic hepatitis B carriers: a pilot, open label, clinical trial in human volunteers.
Antigen-presenting autologous dendritic cells (ADCs), primed with antigen, have been used in immunotherapy. We evaluated ADCs for treatment of chronic hepatitis B (CHB). ADCs were administered to 380 CHB patients. Virological, biochemical, and serological responses were evaluated in each patient over the course of 48 weeks. Undetectable levels of HBV DNA were reported in 46.36% of patients negative for the hepatitis B "e" antigen (HBeAg) and 3.13% HBeAg-positive patients. Normalization of alanine aminotransferase levels occurred in both HBeAg-positive (P=0.007) and HBeAg-negative (P=0.003) patients. It appears that ADC vaccination effectively reconstructed the immunity and elicited virological, serological, and biochemical improvements in some patients with chronic HBV. No side effects were observed.
Luo
Jin
J
Institute of Genetic Diagnosis, Department of Pharmacogenomics, School of Pharmacy, The Fourth Military Medical University, 169 Changle West Road, Xi'an 710032, Shaanxi, China.
Li
Jun
J
Chen
Rui L
RL
Nie
Lei
L
Huang
Jie
J
Liu
Zheng W
ZW
Luo
Lin
L
Yan
Xiao J
XJ
D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000956:Antigens, Viral / Q000276:immunology*; D004279:DNA, Viral / Q000097:blood; D003713:Dendritic Cells / Q000276:immunology*; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology*; D019694:Hepatitis B, Chronic / Q000276:immunology* / Q000628:therapy*; D006805:Human Experimentation; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D014182:Transplantation, Autologous / Q000009:adverse effects / Q000276:immunology*; D016896:Treatment Outcome; D014612:Vaccines / Q000009:adverse effects / Q000276:immunology*; D055815:Young Adult
D000956:Antigens, Viral; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D014612:Vaccines; D000410:Alanine Transaminase