A phase I study of the safety and immunogenicity of recombinant hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide adjuvant

Vaccine

Volumn 21, Issue 19-20, 2003, Pages 2461-2467

  Halperin, Scott A ^a   Van Nest, Gary ^b   Smith, Bruce ^a   Abtahi, Simin ^b   Whiley, Heather ^b   Eiden, Joseph J ^b  

^a DALHOUSIE UNIVERSITY   (Canada)

^b Dynavax Technologies Corporation   (United States)

Author keywords

CpG motifs; Hepatitis B vaccine; Immunostimulatory sequence; Randomized controlled trial

Indexed keywords

5' THREONYLGLYCYLALANYLCYSTEINYLTHREONYLGLYCYLTHREONYLGLYCYLALANYLALANYLCYSTEINYLGL YCYLTHREONYLTHREONYLCYSTEINYLGLYCYLALANYLGLYCYLALANYLTHREONYLGLYCYLALANINE 3'; HEPATITIS B CORE ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE; IMMUNOLOGICAL ADJUVANT; OLIGODEOXYNUCLEOTIDE PHOSPHOROTHIOATE; PEPTIDE; RECOMBINANT ANTIGEN; UNCLASSIFIED DRUG;

ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTHRALGIA; ARTICLE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISORIENTATION; DNA SEQUENCE; DRUG TOLERABILITY; DYSPNEA; EDEMA; ERYTHEMA; FATIGUE; HEADACHE; HEPATITIS B VIRUS; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INJECTION; INJECTION PAIN; INJECTION SITE; INJECTION WARMTH; LIMB MOVEMENT; MYALGIA; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SERUM; SIDE EFFECT; VERTIGO;

EID: 0037726807     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(03)00045-8     Document Type: Article

References (41)

1. Centers for Disease Control and Prevention. Hepatitis B vaccination - United States, 1982-2002. MMWR Morb Mortal Wkly Rep 2002;51:549-63.
2. Lee W.M. Hepatitis B virus infection. N. Engl. J. Med. 337:1997;1733-1743.
3. McMahon B.J., Alward W.L., Hall D.B., Heyward W.L., Bender T.R., Francis D.P.et al. 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.
4. Beasley RP, Hwang L-Y. Overview on the epidemiology of hepatocellular carcinoma. In: Hollinger FB, Lemon SB, Margolis HS, editors. Viral hepatitis and liver disease. Baltimore: Williams & Wilkins; 1991. p. 532-5.
5. Maynard JE, Kane MA, Alter MJ, Halder SC. Control of hepatitis B by immunization: global perspectives. In: Vyas GN, Dienstag JL, Hoofnagle JH, editors. Viral hepatitis and liver disease. New York: Grune & Stratton; 1988. p. 967-9.
6. Huang K., Lin S. Nationwide vaccination: a success story in Taiwan. Vaccine. 18(Suppl. 1):2000;S35-S38.
7. Szmuness W., Stevens C.E., Harley E.J., Zang E.A., Oleszko W.R., William D.C.et al. Hepatitis B vaccine: demonstration of efficacy in a controlled trial in a high risk population in the U.S. N. Engl. J. Med. 303:1980;833-841.
8. Andre F.E. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am. J. Med. 87(Suppl. 3a):1989;39-45.
9. Mahoney FJ, Kane M. Hepatitis B vaccine. In: Plotkin SA, Orenstein WA, editors. Vaccines. Philadelphia: Saunders; 1999. p. 158-82.
10. Cassidy W.M., Watson B., Ioli V.A., Williams K., Bird S., West D.J. 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.
11. Centers for Disease Control and Prevention. Hepatitis B vaccination among high-risk adolescents and adults - San Diego, California, 1998-2001. MMWR Morb Mortal Wkly Rep 2002;51:618-21.
12. Yamamoto S., Yamamoto T., Shimada S., Kuramoto E., Yano O., Kataoka T.et al. DNA from bacteria, but not from vertebrates, induces interferons, activates natural killer cells and inhibits tumor growth. Microbiol. Immunol. 36:1992;983-987.
13. Yamamoto S., Yamamoto T., Kataoka T., Kuramoto E., Yano O., Tokunaga T. Unique palindromic sequences in synthetic oligonucleotides are required to induce IFN and augment IFN-mediated natural killer activity. J. Immunol. 148:1992;4072-4076.
14. Sonehara K., Saito H., Kuramoto E., Yamamoto S., Yamamoto T., Tokunaga T. Hexamer palindromic oligonucleotides with 5′-CG-3′ motif(s) induce production of interferon. J. Interferon Cytokine Res. 16:1996;799-803.
15. Halpern M.D., Kurlander R.J., Pisetsky D.S. Bacterial DNA induces murine interferon-gamma production by stimulation of interleukin-12 and tumor necrosis factor-alpha. Cell Immunol. 167:1996;72-78.
16. Klinman D.M., Yi A.K., Beaucage S.L., Conover J., Krieg A.M. CpG motifs present in bacteria DNA rapidly induce lymphocytes to secrete interleukin 6, interleukin 12, and interferon gamma. Proc. Natl. Acad. Sci. U.S.A. 93:1996;2879-2883.
17. Roman M., Martin-Orozco E., Goodman J.S., Nguyen M.D., Sato Y., Ronaghy A.et al. Immunostimulatory DNA sequences function as T helper-1-promoting adjuvants. Nat. Med. 3:1997;849-854.
18. Krieg A.M., Matson S., Fisher E. Oligodeoxynucleotide modifications determine the magnitude of B cell stimulation by CpG motifs. Antisense Nucelic Acid. Drug. Dev. 6:1996;133-139.
19. Krieg A.M., Yi A.K., Matson S., Waldschmidt T.J., Bishop G.A., Teasdale R.et al. CpG motifs in bacterial DNA trigger direct B-cell activation. Nature. 374:1995;546-549.
20. Liang H., Nishioka Y., Reich C.F., Pisetsky D.S., Lipsky P.E. Activation of human B cells by phosphorothioate oligodeoxynucleotides. J. Clin. Invest. 98:1996;1119-1129.
21. Hartmann G., Weiner G.J., Krieg A.M. CpG DNA: a potent signal for growth, activation, and maturation of human dendritic cells. Proc. Natl. Acad. Sci. U.S.A. 96:1999;9305-9310.
22. Martin-Orozco E., Kobayashi H., Van Uden J., Nguyen M.D., Kornbluth R.S., Raz E. Enhancement of antigen-presenting cell surface molecules involved in cognate interactions by immunostimulatory DNA sequences. Int. Immunol. 11:1999;1111-1118.
23. Klinman D.M., Yamshchikov G., Ishigatsubo Y. Immunostimulatory DNA sequences necessary for effective intradermal gene immunization. J. Immunol. 158:1997;3635-3639.
24. Sato Y., Roman M., Tighe H., Lee D., Corr M., Nguyen M.D.et al. Immunostimulatory DNA sequences necessary for effective intradermal gene immunization. Science. 273:1996;352-354.
25. Weiner G.J., Liu H.M., Wooldridge J.E., Dahle C.E., Krieg A.M. Immunostimulatory oligodeoxynucleotides containing the CpG motif are effective as immune adjuvants in tumor antigen immunization. Proc. Natl. Acad. Sci. U.S.A. 94:1997;10833-10837.
26. Chu R.S., Targoni O.S., Krieg A.M., Lehmann P.V., Harding C.V. CpG oligodeoxynucleotides act as adjuvants that switch on T helper 1 (Th1) immunity. J. Exp. Med. 186:1997;1623-1631.
27. Davis H.L., Weeranta R., Waldschmidt T.J., Tygrett L., Schorr J., Krieg A.M. CpG DNA is a potent enhancer of specific immunity in mice immunized with recombinant hepatitis B surface antigen. J. Immunol. 160:1998;870-876.
28. Heineman T., Clements-Mann M.L., Poland G.A., Jacobson R.M., Izu A.E., Sakamoto D.et al. A randomized, controlled study in adults of the immunogenicity of a novel hepatitis B vaccine containing MF59 adjuvant. Vaccine. 17:1999;2769-2778.
29. Halperin S.A., Smith B., Russell M., Hasselback P., Guasparini R., Skowronski D.et al. An adult formulation of a five-component acellular pertussis vaccine combined with diphtheria and tetanus toxoids is safe and immunogenic in adolescents and adults. Vaccine. 18:2000;1312-1319.
30. Andre F., Safary A. Summary of clinical findings on Engerix-B a genetically engineered yeast-driven hepatitis B vaccine. Postgrad. Med. J. 63:1987;169-178.
31. Miskovsky E., Gershman K., Clements M.L., Cupps T., Calandra G., Hesley T., Ioli V.et al. Comparative safety and immunogenicity of yeast recombinant hepatitis B vaccines containing S and pre-S2 + S. Vaccine. 9:1991;346-350.
32. Bryan J.P., Craig P.G., Reyes L., Hakre S., Jaramillo R., Harlan H.et al. Randomized comparison of 5 and 10 μg doses of two recombinant hepatitis B vaccines. Vaccine. 13:1995;978-982.
33. Jilg W., Schmidt M., Deinhardt F. Vaccination against hepatitis B: comparison of three different vaccination schedules. J. Infect. Dis. 160:1989;766-769.
34. Ambrosch F., Wiedermann G., Kundi M., Leroux-Roels G., Desombere I., Garcon N.et al. A hepatitis B vaccine formulated with a novel adjuvant system. Vaccine. 18:2000;2095-2101.
35. Cassidy W.M., Watson B., Ioli V.A., Williams K., Bird S., West D.J. A randomized trial of alternative two- and three-dose hepatitis B vaccination regimens in adolescents: antibody responses, safety, and immunological memory. Pediatrics. 107:2001;626-631.
36. Van Nest G, Tighe H, Raz E, Higgins D, Traquina P, Eiden J. An immunostimulatory oligonucleotide (ISS ODN) enhances immune response to HBV vaccine in a variety of animal species including primates. In: Proceedings of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, 1999 [Abstract 374].
37. Davis H, Cooper CL, Morris ML, Elfer SM, Cameron DW, Heathcote J. CpG ODN is safe and highly effective in humans as adjuvant to HBV vaccine: preliminary results of phase I trial with CpG ODN 7909. In: Proceedings of the Third Annual Conference on Vaccine Research, Washington, DC, May 2000 [Abstract S25].
38. Denis F., Mounier M., Hessel L., Michel J.P., Gualde N., Dubois F.et al. Hepatitis B vaccination in the elderly. J. Infect. Dis. 149:1984;1019.
39. Heyward W.L., Bender T.R., McMahon B.J., Hall D.B., Francis D.P., Lanier A.P.et al. The control of hepatitis B virus infection with vaccine in Yupik Eskimos. Am. J. Epidemiol. 121:1995;914-923.
40. McLean A.A., Hilleman M.R., McAleer W.J., Buynak E.B. Summary of worldwide experience with HB-Vx (R) (B, MSD). J. Infect. Dis. 7:1983;95-104.
41. Weber D.J., Rutala W.A., Samsa G.P., Santimaw J.E., Lemon S.M. Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine. J. Am. Med. Assoc. 254:1985;3187-3189.