Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, hepatitis C or HTLV-II infection\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion\r\n* A positive hepatitis C serology is an exclusion criterion
Documented human immunodeficiency virus (HIV), active bacterial infections, active or chronic hepatitis B, hepatitis C\r\n* Positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antigen [HBsAb] positive and hepatitis B core antibody [HBcAb] negative) or a fully resolved acute hepatitis B infection is not an exclusion criterion\r\n* Positive hepatitis C serology is an exclusion criterion\r\nNOTE: HIV-positive patients are excluded from the study
Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection-a positive hepatitis B serology indicative or previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection \r\n* NOTE: A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb]-positive and hepatitis B core antibody [HBcAb]-negative), or a fully resolved acute hepatitis B virus infection is not an exclusion criterion
Documented cirrhosis or documented acute hepatitis; Note: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Active or chronic hepatitis B, hepatitis C or human T-cell lymphotropic virus (HTLV)-I infection; NOTE: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis C core antibody [HBcAb] negative), chronic asymptomatic viral hepatitis or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection; subjects who may not tolerate immune-mediated hepatitis due to compromised hepatic reserve are also excluded from participation including: ) subjects with extensive liver metastasis (as judged by the investigator) ) subjects who drink more than two standard alcoholic beverages per day on a regular basis ) subjects who consume more than grams of acetaminophen per day on a regular basis\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Cirrhosis, chronic hepatitis C virus positivity, or chronic hepatitis B infection; subjects who may not tolerate immune-mediated hepatitis due to compromised hepatic reserve also excluded from participation including: subjects with extensive liver metastasis (as judged by the investigator); subjects who drink more than two standard alcoholic beverages per day on a regular basis; subjects who consume more than grams of acetaminophen per day on a regular basis\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb]-positive and hepatitis B core antibody [HBcAb]-negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion
Patient has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)\r\n* Note: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb]-positive and hepatitis B core antibody [HBcAb]-negative) or a fully resolved acute hepatitis B infection is not an exclusion criterion
A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B virus surface antibody [HBsAb] positive and hepatitis B virus core antibody [HBcAb] negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion
Positive serology for human T-lymphotropic virus (HTLV) I, human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection including a positive hepatitis B serology indicative of previous immunization (i.e. hepatitis B surface antibody [HBs Ab] positive and hepatitis B core antibody [HBc Ab] negative)
No history of human immunodeficiency virus (HIV), active or chronic hepatitis B, hepatitis C or human T-cell lymphotropic virus (HTLV-I) infection; NOTE: a positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion
Documented human immunodeficiency virus (HIV), active or chronic hepatitis B, hepatitis C or human T-lymphotropic virus (HTLV)-I infection\r\n* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis C antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion\r\n* Positive hepatitis C serology is an exclusion criterion