Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease and type 2 diabetes mellitus

Vaccine

Volumn 33, Issue 7, 2015, Pages 833-837

  Janssen, Julia M ^a   Heyward, William L ^b   Martin, J Tyler ^c   Janssen, Robert S ^a  

^a Dynavax Technologies Corporation   (United States)

^b Quattro Clinical Research   (United States)

^c Adjuvance Technologies Inc   (United States)

Author keywords

CKD; Hepatitis B vaccine; NCT00985426; Toll like receptor 9; Type 2 diabetes

Indexed keywords

HEPATITIS B SURFACE ANTIBODY; HEPATITIS B VACCINE; RECOMBINANT HEPATITIS B VACCINE; TOLL LIKE RECEPTOR 9; HEPATITIS B ANTIBODY; HEPATITIS B SURFACE ANTIGEN; IMMUNOLOGICAL ADJUVANT; TLR9 PROTEIN, HUMAN;

ADULT; AGED; ANTIBODY BLOOD LEVEL; ARTICLE; AUTOIMMUNE DISEASE; CHRONIC KIDNEY DISEASE; CHRONOTHERAPY; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DIABETIC PATIENT; DOSE RESPONSE; DRUG FATALITY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TARGETING; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEPATITIS B; HUMAN; IMMUNOGENICITY; INJECTION SITE PAIN; INJECTION SITE SWELLING; MAJOR CLINICAL STUDY; MALAISE; MALE; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; MYALGIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL (TOPIC); PREVENTION STUDY; PREVENTIVE HEALTH SERVICE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTECTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SECONDARY ANALYSIS; SEROPROTECTION; SINGLE DRUG DOSE; SKIN REDNESS; TREATMENT RESPONSE; VACCINATION; ADOLESCENT; AGONISTS; DIABETES MELLITUS, TYPE 2; IMMUNOLOGY; RANDOMIZED CONTROLLED TRIAL; RENAL INSUFFICIENCY, CHRONIC; YOUNG ADULT;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; DIABETES MELLITUS, TYPE 2; FEMALE; HEPATITIS B; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VACCINES; HUMANS; MALE; MIDDLE AGED; RENAL INSUFFICIENCY, CHRONIC; TOLL-LIKE RECEPTOR 9; YOUNG ADULT;

EID: 84921717927     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.12.060     Document Type: Article

References (15)

1. Centers for Disease Control and Prevention Announcement: national kidney month-March 2014. MMWR 2014, 63(09):204.
2. U.S Renal Data System. An introduction to end-stage renal disease in the US. USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. 2013;(2):160.
3. U.S Renal Data System. CKD in the general population. USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. 2013;(1):1:44.
4. Centers for Disease Control and Prevention Recommendations for preventing transmission of infections among chronic hemodialysis patients. MMWR Recomm Rep 2001, 50(RR-5):1-43.
5. Reilly M.L., Schillie S.F., Smith E., Poissant T., et al. Increased risk of acute hepatitis B among adults with diagnosed diabetes mellitus. J Diabetes Sci Technol 2012, 6(4):858-866.
6. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Use of vaccines and immune globulins for persons with altered immunocompetence. MMWR Recomm Rep 1993, 42(Apr (RR-4)):1-18.
7. Centers for Disease Control and Prevention Use of hepatitis B vaccination for adults with diabetes mellitus: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011, 60(50):1709-1711.
8. DaRoza G., Loewen A., Djurdjev O., Love J., et al. Stage of chronic kidney disease predicts seroconversion after hepatitis B immunization: earlier is better. Am J Kidney Dis 2003, 42(6):1184-1192.
9. Schillie S., Spradling P., Murphy T. Immune response of hepatitis B vaccine among persons with diabetes: a systematic review of the literature. Diabetes Care 2012, 35(12):2690-2697.
10. Alavian S.M., Tabatabaei S.V. The effect of diabetes mellitus on immunological response to hepatitis B virus vaccine in individuals with chronic kidney disease: a meta-analysis of current literature. Vaccine 2010, 28(22):3773-3777.
11. Centers for Disease Control and Prevention A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: Immunization of adults. MMWR Recomm Rep 2006, 55(RR-16):1-40.
12. Miller E.R., Alter M.J., Tokars J.I. Protective effect of hepatitis B vaccine in chronic hemodialysis patients. Am J Kidney Dis 1999, 33(2):356-360.
13. Janssen R.S., Mangoo-Karim R., Pergola P.E., Girndt M., et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine 2013, 31(46):5306-5313.
14. Newcombe R.G. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998, 17(8):873-890.
15. Janssen R.S., Xie F., Heyward W., Martin T. Antibody decay up to 1.5 years after last dose of investigational HEPLISAV compared with licensed hepatitis B virus vaccine (Engerix-B) in patients with chronic kidney disease. Presented at Kidney Week 2012 2012, November 2012, San Diego, CA, SA-PO132.