Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults

Vaccine

Volumn 24, Issue 1, 2006, Pages 20-26

  Halperin, Scott A ^a   Dobson, Simon ^b   McNeil, Shelly ^a   Langley, Joanne M ^a   Smith, Bruce ^a   McCall Sani, Robyn ^a   Levitt, Dan ^c   Nest, Gary Van ^c   Gennevois, Daniel ^c,e   Eiden, Joseph J ^c,d  

^a DALHOUSIE UNIVERSITY   (Canada)

^b BC CHILDREN S HOSPITAL   (Canada)

^c Dynavax Technologies Corporation   (United States)

^d CERUS CORPORATION   (United States)

^e Department of Research   (United States)

Author keywords

Hepatitis B vaccine; Immunostimulatory sequences; Randomized clinical trial

Indexed keywords

HEPATITIS VACCINE; MEMBRANE ANTIGEN; MENINGOCOCCUS VACCINE; OLIGODEOXYNUCLEOTIDE PHOSPHOROTHIOATE; RECOMBINANT HEPATITIS B VACCINE; VIRUS ANTIGEN;

ADULT; ANTIBODY RESPONSE; ARTHRALGIA; CHILL; CLINICAL TRIAL; COMPARATIVE STUDY; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; EDEMA; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HEPATITIS B VIRUS; HUMAN; IMMUNOGENICITY; IMMUNOSTIMULATION; INJECTION SITE REACTION; MALE; MYALGIA; NORMAL HUMAN; PAIN; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; FEMALE; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; MALE; OLIGONUCLEOTIDES; THIONUCLEOTIDES;

EID: 28344457315     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2005.08.095     Document Type: Conference Paper

References (30)

1. J.E. Maynard, M.A. Kane, M.J. Alter, and S.C. Halder Control of hepatitis B by immunization: global perspectives G.N. Vyas J.L. Dienstag J.H. Hoofnagle Viral hepatitis and liver disease 1988 Grune & Stratton New York 967 969
2. B.J. McMahon, W.L. Alward, D.B. Hall, W.L. Heyward, T.R. Bender, and D.P. Francis Acute hepatitis B virus infection: relation of age to the clinical expression of disease and subsequent development of the carrier state J Infect Dis 151 1985 599 603
3. R.P. Beasley, and L.-Y. Hwang Overview on the epidemiology of hepatocellular carcinoma F.B. Hollinger S.B. Lemon H.S. Margolis Viral hepatitis and liver disease 1991 Williams & Wilkins Baltimore 532 535
4. Advisory Committee on Immunization Practices. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Immunization Practices Advisory Committee (ACIP). Morb Mortal Wkly Rep 1991; 40(RR-13):1-19.
5. K. Huang, and S. Lin Nationwide vaccination: a success story in Taiwan Vaccine 18 Suppl 1 2000 S35 S38
6. F.E. Andre Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine Am J Med 87 Suppl 3a 1989 14 20
7. F.J. Mahoney, and M. Kane Hepatitis B vaccine S.A. Plotkin W.A. Orenstein Vaccines 1999 Saunders Philadelphia 158 182
8. T.C. Heineman, M.L. Clements-Mann, G.A. Poland, R.M. Jacobson, A.E. Izu, and D. Sakamoto A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant Vaccine 17 1999 2769 2778
9. F. Ambrosch, G. Wiedermann, M. Kundi, G. Leroux-Roels, I. Desombere, and N. Garcon A hepatitis B vaccine formulated with a novel adjuvant system Vaccine 18 2000 209 2101
10. F. Andre, and A. Safary Summary of clinical findings on Engerix-B, a genetically engineered yeast-derived hepatitis B vaccine Postgrad Med J 63 Suppl 2 1987 169 178
11. W.M. Cassidy, B. Watson, V.A. Ioli, K. Williams, S. Bird, and D.J. West A randomized trial of alternative two- and three-dose hepatitis B vaccination regimens in adolescents: antibody responses, safety, and immunologic memory Pediatrics 107 2001 626 631
12. Centers for Disease Control and Prevention. Hepatitis B vaccination among high-risk adolescents and adults, San Diego, California, 1998-2001. Morb Mortal Wkly Rep 2002; 51:618-21.
13. F. Denis, M. Mounier, L. Hessel, J.P. Michel, N. Gualde, and F. Dubois Hepatitis B vaccination in the elderly J Infect Dis 149 1984 1019
14. A.A. McLean, M.R. Hilleman, W.J. McAleer, and E.B. Buynak Summary of worldwide clinical experience with H-B-Vx (R) (B, MSD) J Infect 7 Suppl 1 1983 95 104
15. D.J. Weber, W.A. Rutala, G.P. Samsa, J.E. Santimaw, and S.M. Lemon Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine JAMA 254 1985 3187 3189
16. D.S. Pisetsky Immune activation by bacterial DNA: a new genetic code Immunity 5 1996 303 310
17. A.P. Bird CpG-rich islands and the function of DNA methylation Nature 321 1986 209 213
18. S. Yamamoto, T. Yamamoto, T. Katakoa, E. Kuramoto, O. Yano, and T. Takunaga Unique palindromic sequences in synthetic oligonuclotides are required to induce IFN and augment IFN-mediated natural killer activity J Immunol 148 1992 4072 4076
19. S. Yamamoto, T. Yamamoto, S. Shimada, E. Kuramoto, O. Yano, and T. Kataoka DNA from bacteria, but not from vertebrates, induces interferons, activates natural killer cells and inhibits tumor growth Microbiol Immunol 36 1992 983 987
20. K. Sonehara, H. Saito, E. Kuramoto, S. Yamamoto, YamamotoT, and T. Tokunaga Hexamer palindromic oligonucleotides with 5′-CG-3′ motif(s) induce production of interferon J Interferon Cytokine Res 16 1996 799 803
21. M.D. Halpern, R.J. Kurlander, and D.S. Pisetsky Bacterial DNA induces murine interferon-gamma production by stimulation of interleukin-12 and tumor necrosis factor-alpha Cell Immunol 167 1996 72 78
22. D.M. Klinman, A.K. Yi, S.L. Beaucage, J. Conover, and A.M. Krieg CpG motifs present in bacteria DNA rapidly induce lymphocytes to secrete interleukin 6, interleukin 12, and interferon gamma Proc Natl Acad Sci USA 93 1996 2879 2883
23. A.M. Krieg, S. Matson, and E. Fisher Oligodeoxynucleotide modifications determine the magnitude of B cell stimulation by CpG motifs Antisense Nucelic Acid Drug Dev 6 1996 133 139
24. A.M. Krieg, A.K. Yi, S. Matson, T.J. Waldschmidt, G.A. Bishop, and R. Teasdale CpG motifs in bacterial DNA trigger direct B-cell activation Nature 374 1995 546 549
25. H. Liang, Y. Nishioka, C.F. Reich, D.S. Pisetsky, and P.E. Lipsky Activation of human B cells by phosphorothioate oligodeoxynucleotides J Clin Invest 98 1996 1119 1129
26. G. Hartmann, G.J. Weiner, and A.M. Krieg CpG DNA: a potent signal for growth, activation, and maturation of human dendritic cells Proc Natl Acad Sci USA 96 1999 9305 9310
27. E. Martin-Orozco, H. Kobayashi, J. Van Uden, M.D. Nguyen, R.S. Kornbluth, and E. Raz Enhancement of antigen-presenting cell surface molecules involved in cognate interactions by immunostimulatory DNA sequences Int Immunol 11 1999 1111 1118
28. M. Roman, E. Martin-Orozco, J.S. Goodman, M.D. Nguyen, Y. Sato, and A. Ronaghy Immunostimulatory DNA sequences function as T helper-1-promoting adjuvants Nat Med 3 1997 849 854
29. S.A. Halperin, G. Van Nest, B. Smith, S. Abtahi, H. Whiley, and J.J. Eiden A phase 1 study of the safety and immunogenicity or recombinant hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligonucelotide adjuvant Vaccine 21 2003 2461 2467
30. C.-A. Siegrist, M. Pihlgren, C. Tougne, S.M. Efler, M.L. Morris, and M.J. AlAdhami Co-administration of CpG oligonucleotides enhances the late affinity maturation process of anti-hepatitis B vaccine response Vaccine 23 2004 615 622