1 / 17

quality issues dosages schedules

Hepatitis B vaccines:. quality issues dosages schedules. Wolfgang Jilg Institute for Medical Microbiology and Hygiene University of Regensburg Regensburg, Germany. Manufacturers of WHO “Prequalified” Hepatitis B Vaccines. Manufacturer Glaxo/SKB (Belgium) Merck (USA) Green Cross (Korea)

lorant
Download Presentation

quality issues dosages schedules

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Hepatitis B vaccines: • quality issues • dosages • schedules Wolfgang Jilg Institute for Medical Microbiology and Hygiene University of Regensburg Regensburg, Germany

  2. Manufacturers of WHO “Prequalified” Hepatitis B Vaccines Manufacturer Glaxo/SKB (Belgium) Merck (USA) Green Cross (Korea) Lucky Goldstar (Korea) Cheil Jedang (Korea) Glaxo/SKB (Belgium) Glaxo/SKB (Belgium) Vaccine Hep B (recombinant) Hep B (plasma-derived) DPT-Hep B DPT-Hep B-Hib

  3. Product (1) Recombivax (MSD) (Gen-HB-Vax) (2) Engerix B (GSK) (3) Heprecomb Berna (4) Genhevac B Pasteur (5) Hepacare (Medeva) Recombinant hepatitis B vaccines in Europe dosage (g)* childr. adol. adults 5 5 10 10 10 20 5 10 10 20 20 20 - - 20 source/ (antigen) yeast (S) yeast (S) yeast (S) CHO (S+PreS2) C127I (S+PreS2 + trunc. S1) * recom. schedules: month 0,1,6 (1)-(5); month 0,1,2,12 (1)-(4)

  4. What should be expected from an effective hepatitis B vaccine? minimum requirements: • seroprotection rate (% individuals with anti-HBs  10 IU/L) 95 % • GMT > 500 IU/L in healthy young adults (< 40 years), 1-2 months after booster dose

  5. Influence of dosage on the immune response

  6. month after first vaccination Immune responses to different doses of HB-vaccine (plasma-derived vaccine; Jilg et al 1988)

  7. age (years) Vaccination against hepatitis B with Recombivax (10 g) or Engerix B (20 g) (Averhoff et al, Am J Prev Med 1998; 15: 1)

  8. Recombivax Engerix B (n=881) (n=873) 92% 93% seroprotection 2138 IU/L 1047 IU/L GMT 87% 81% seroprotection 288 IU/L 1000 IU/L GMT Vaccination against hepatitis B with Recombivax (10 g) or Engerix B (20 g) (Averhoff et al, Am J Prev Med 1998; 15: 1) individuals <40 years: individuals 40 years:

  9. Recombivax Engerix B Vaccination against hepatitis B with Recombivax or Engerix B: same dosage (Bryan et al, Vaccine 1995; 13: 978) 5 g doses (n=22/87): seroprotection98% 86% GMT570 IU/L 177 IU/L 10 g doses (n=46/91) : seroprotection100% 91% GMT744 IU/L 325 IU/L

  10. Influence of dosage on the immune response • higher dosage results in higher seroconversion rates and GMTs • doses recommended by the manufacturer are sufficient • correlation not linear • especially pronounced in elderly or immuno- suppressed

  11. Influence of schedule on the immune response

  12. 19912 IU/L 5846 IU/L 11798 IU/L 53 IU/L Vaccination against hepatitis B using different schedules (Jilg et al 1989) vaccinations month after first vaccination

  13. 2493 IU/L Vaccination against hepatitis B using different schedules (Cassidy et al 2001) month after first vaccination

  14. 2493 IU/L 675 IU/L Vaccination against hepatitis B using different schedules (Cassidy et al 2001) month after first vaccination

  15. 2493 IU/L 1136 IU/L Vaccination against hepatitis B using different schedules (Cassidy et al 2001) 675 IU/L month after first vaccination

  16. Influence of schedule on the immune response • immune responses increase with increasing interval between the first and third dose • additional dose at month 2 increases early but not final immune response when booster dose is given at month 12 • minor delays in giving the 2nd or 3rd dose are un- likely to have a negative impact on vaccine response

  17. The End

More Related