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

Human Vaccines

Volumn 5, Issue 2, 2009, Pages 92-97

  Van Damme, Pierre ^a   Minervini, Gianmaria ^b   Liss, Charles L ^b   McCarson, Barbara ^b   Vesikari, Timo ^c   Boslego, John W ^b   Bhuyan, Prakash K ^b  

^a UNIVERSITY OF ANTWERP   (Belgium)

^b MERCK RESEARCH LABORATORIES   (United States)

^c UNIVERSITY OF TAMPERE MEDICAL SCHOOL   (Finland)

Author keywords

Hepatitis B; Immunogenicity; Recombivax; Safety; Seroprotection rate

Indexed keywords

HEPATITIS ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE; MODIFIED PROCESS HEPATITIS B VACCINE; RECOMBINANT HEPATITIS B VACCINE; UNCLASSIFIED DRUG;

ADULT; ANKLE FRACTURE; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTICLE; BREAST TUMOR; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG FATALITY; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FACE FRACTURE; FEMALE; HEPATITIS B VIRUS; HUMAN; HUMAN EXPERIMENT; IMMUNOASSAY; IMMUNOGENICITY; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE REACTION; INTERVERTEBRAL DISK HERNIA; KIDNEY DISEASE; LUNG TUMOR; MALE; MOUTH CANCER; MOUTH TEMPERATURE; NORMAL HUMAN; OVARY CYST; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTEMIC DISEASE; VACCINATION; VACCINE PRODUCTION;

ADULT; FEMALE; HEPATITIS B ANTIBODIES; HEPATITIS B VACCINES; HUMANS; MALE; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 67349227948     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.5.2.6587     Document Type: Article

References (14)

1. Lee WM. Hepatitis B virus infection. N Engl J Med 1997; 337:1733-45.
2. Goldstein ST, Zhou F, Hadler SC, Bell BP, Mast EE, Margolis HS. A mathematical model to estimate global hepatitis B disease burden and vaccination impact. Int J Epidemiol 2005; 34:1329-39.
3. Loomba R, Liang TJ. Treatment of chronic hepatitis B. Antivir Ther 2007; 12:33-41.
4. WHO Bulletin, Expanded Programme on Immunization, Hepatitis B Vaccine - Making Global Progress. October 1996.
5. U.S. Package Circular: Hepatitis B vaccine (recombinant), RECOMBIVAX HB®: June 2005.
6. Centers for Disease Control. National Immunization Program. Adult Immunization Schedule. Available at: http://www.cdc.gov/nip/recs/ adult-schedule.htm. Accessed 2006.
7. Wasley A, Miller JT, Finelli L. Centers for Disease Control and Prevention (CDC). Surveillance for acute viral hepatitis - United States, 2005. MMWR Surveill Summ 2007; 56:1-24.
8. New Zealand Ministry of Health. Immunisation Handbook 2006. Wellington: Ministry of Health. Available at: http://www.moh.govt.nz/moh.nsf/pagesmh/ 4617/$File/200603hepatitis.pdf. Accessed 2007.
9. Romero Mendez IZ, Shi Y, HogenEsch H, Hem SL. Potentiation of the immune response to non-adsorbed antigens by aluminum-containing adjuvants. Vaccine 2007; 25:825-33.
10. Seeff LB, Wright EC, Zimmerman HJ, Alter HJ, Dietz AA, Felsher BF et al. Type B hepatitis after needle-stick exposure: prevention with hepatitis B immune globulin. Final report of the Veterans Administration Cooperative Study. Ann Intern Med 1978; 88:285-93.
11. Cassidy WM, Watson B, Ioli VA, Williams K, Bird S, West DJ. A randomized trial of alternative two-and three-dose hepatitis B vaccination regimens in adolescents: antibody responses, safety and immunologic memory. Pediatrics 2001; 107:626-31.
12. Marsano LS, West DJ, Chan I, Hesley TM, Cox J, Hackworth V et al. A two-dose hepatitis B vaccine regimen: proof of priming and memory responses in young adults. Vaccine 1998; 1:624-9.
13. Hessel L, West DJ. Antibody responses to recombinant hepatitis B vaccines. Vaccine 2002; 20:2164-5.
14. World Health Organization: Department of Communicable Diseases and Response. Epidemic and Pandemic Alert and Response on Hepatitis B. Available at: http://www.who.int/csr/disease/hepatitis/ HepatitisB_whocdscsrlyo2002_2.pdf. Accessed 2008.