Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults

• DOI: 10.4161/hv.5.2.6587
• Publication Date: 2010-01-04T14:31:28Z
• Authors: Pierre Van Damme; Gianmaria Minervini; Charles L. Liss; Barbara McCarson; Timo Vesikari; John W. Boslego; Prakash K. Bhuyan
• Keywords: Tolerability; Hepatitis B vaccine; Hepatitis A vaccine

Merck has developed a manufacturing process modification for RECOMBIVAX HB. Three lots of modified hepatitis B vaccine (mpHBV) were studied in randomized, blinded trial to demonstrate similarity the three mpHBV and noninferiority HB (control vaccine) with regard immunogenicity.Month 7 SPRs groups ranged from 97.8 98.9% (98.2% combined). The seroprotection rate (SPR) control group was 98.5%. estimated geometric mean titer (GMT) 1761 mIU/mL combined 1108 group. GMT ratio (mpHBV/control) 1.6 [95% confidence interval (CI): 1.2 2.1], indicating superiority compared control. percentages subjects reporting any adverse experience (AE), injection-site AEs, or systemic AEs similar across four vaccination groups. There no serious AEs.Healthy 20-to 35-year-old (N = 860) received 1-mL intramuscular dose [10 mcg surface antigen (HBsAg)] 1 3 at Day 1, Months 6. Serum antibody HBsAg (anti-HBs) assayed Predose month Postdose (Month 7) using quantitative assay (Ortho VITROS ECi assay). Anti-HBs GMTs (% an anti-HBs > =10 mIU/mL) Month 7. After each dose, oral temperature recorded 5 days; 15 days.The high; responses consistent vaccines generally well tolerated.