Safety and immunogenicity of different two-dose regimens of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in healthy young adults

Vaccine

Volumn 30, Issue 36, 2012, Pages 5445-5448

  Halperin, Scott A ^a   McNeil, Shelly ^a   Langley, Joanne M ^a   Smith, Bruce ^a   MacKinnon Cameron, Donna ^a   McCall Sani, Robyn ^a   Heyward, William L ^b   Martin, J Tyler ^b  

^a DALHOUSIE UNIVERSITY   (Canada)

^b Dynavax Technologies Corporation   (United States)

Author keywords

Hepatitis B vaccine; Immunostimulatory sequences; Randomized trial

Indexed keywords

HEPATITIS B VACCINE; PHOSPHOROTHIOIC ACID OLIGODEOXYRIBONUCLEOTIDE; PLACEBO; RECOMBINANT HEPATITIS B SURFACE ANTIGEN; UNCLASSIFIED DRUG;

ADULT; ANTIBODY AFFINITY; ANTIBODY BLOOD LEVEL; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FEMALE; GEOMETRY; HEPATITIS B; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; IMMUNOSTIMULATION; MALE; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

ADJUVANTS, IMMUNOLOGIC; ADULT; FEMALE; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; MALE; OLIGODEOXYRIBONUCLEOTIDES; PHOSPHOROTHIOATE OLIGONUCLEOTIDES; YOUNG ADULT;

EID: 84864008155     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.05.074     Document Type: Article

References (20)

1. World Health Organization Hepatitis B vaccines. Weekly Epidemiol Rec 2009, 84:405-420.
2. Andre F.E. Summary of safety and efficacy data on a yeast-derived hepatitis B vaccine. Am J Med 1989, 87(Suppl. 3a):14-20.
3. Jilg W., Schmidt M., Deinhardt F. Vaccination against hepatitis B: comparison of three different vaccination schedules. J Infect Dis 1989, 160:766-769.
4. Mahoney F.J., Kane M. Hepatitis B vaccine. Vaccines 1999, Saunders, Philadelphia, pp. 158-82. S.A. Plotkin, W.A. Orenstein (Eds.).
5. 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 2001, 107:626-631.
6. 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 2000, 18:2095-2101.
7. Andre F., Safary A. Summary of clinical findings on Engerix-B, a genetically engineered yeast-derived hepatitis B vaccine. Post Grad Med J 1987, 63:169-178.
8. Kane M.A. Global status of hepatitis B immunisation. Lancet 1996, 348:696.
9. 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). MMWR Recomm Rep 1991, 40(RR-13):1-19.
10. 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, 51:618-621.
11. Pisetsky D.S. Immune activation by bacterial DNA: a new genetic code. Immunity 1996, 5:303-310.
12. Bird A.P. CpG-rich islands and the function of DNA methylation. Nature 1986, 321:209-213.
13. Coffman R.L., Sher A., Seder R.A. Vaccine adjuvants: putting innate immunity to work. Immunity 2010, 33:492-503.
14. Halperin S.A., Van Nest G., Smith B., Abtahi S., Whiley H., Eiden J.J. A phase 1 study of the safety and immunogenicity of recombinant hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligonucelotide adjuvant. Vaccine 2003, 21:2461-2467.
15. Halperin S.A., Dobson S., McNeil S., Langley J.M., Smith B., McCall-Sani R., et al. 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 2006, 24:20-26.
16. Hadler S.C., de Monzon M.A., Lugo D.R., Perez M. Effect of timing of hepatitis B vaccine doses on response to vaccine in Yucpa Indians. Vaccine 1989, 7:106-110.
17. Herona L.G., Chanta K.G., Jalaludinb B.B. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine 2002, 20:3472-3476.
18. Burgess M.A., McIntyre P.B., Hellard M., Ruff T.A., Lefevre I., Bock H.L. Antibody persistence six years after two doses of combined hepatitis A and B vaccine. Vaccine 2010, 28:2222-2226.
19. McMahon B.J., Bruden D.L., Petersen K.M., Bulkow L.R., Parkinson A.J., Nainan O., et al. Protection after hepatitis B vaccination: results of a 15-year follow-up. Ann Intern Med 2005, 142:333-341.
20. Halperin SA, Ward B, Cooper C, Predy G, Diaz-Mitoma F, Dionne M, et al. Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age. Vaccine 2012; 30:2556-63.