Quality issues measurements plans

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Hepatitis B antibodies: quality issues measurements plans Wolfgang Jilg Institute for Medical Microbiology and Hygiene University of Regensburg, Germany

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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-inferred) DPT-Hep B DPT-Hep B-Hib

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Product (1) Recombivax (MSD) (Gen-HB-Vax) (2) Engerix B (GSK) (3) Heprecomb Berna (4) Genhevac B Pasteur (5) Hepacare (Medeva) Recombinant hepatitis B immunizations 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. plans: month 0,1,6 (1)- (5); month 0,1,2,12 (1)- (4)

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What ought not out of the ordinary from a viable hepatitis B antibody? least prerequisites: seroprotection rate (% people with hostile to HBs  10 IU/L)  95 % GMT > 500 IU/L in solid youthful grown-ups (< 40 years), 1-2 months after promoter measurement

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Influence of dose on the resistant reaction

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month after first immunization Immune reactions to various measurements of HB-antibody (plasma-determined antibody; Jilg et al 1988)

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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)

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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) people <40 years: people  40 years:

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Recombivax Engerix B Vaccination against hepatitis B with Recombivax or Engerix B: same dose (Bryan et al, Vaccine 1995; 13: 978) 5 g measurements (n=22/87): seroprotection 98% 86% GMT 570 IU/L 177 IU/L 10 g dosages (n=46/91) : seroprotection 100% 91% GMT 744 IU/L 325 IU/L

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Influence of dose on the invulnerable reaction higher dose brings about higher seroconversion rates and GMTs doses suggested by the maker are sufficient correlation not straight especially articulated in elderly or immuno- suppressed

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Influence of calendar on the safe reaction

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19912 IU/L 5846 IU/L 11798 IU/L 53 IU/L Vaccination against hepatitis B utilizing diverse timetables (Jilg et al 1989) inoculations month after first immunization

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2493 IU/L Vaccination against hepatitis B utilizing distinctive calendars (Cassidy et al 2001) month after first immunization

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2493 IU/L 675 IU/L Vaccination against hepatitis B utilizing diverse calendars (Cassidy et al 2001) month after first immunization

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2493 IU/L 1136 IU/L Vaccination against hepatitis B utilizing distinctive timetables (Cassidy et al 2001) 675 IU/L month after first inoculation

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Influence of timetable on the insusceptible reaction immune reactions increment with expanding interval between the first and third measurements additional measurement at month 2 increments early however not final safe reaction when booster dosage is given at month 12 minor delays in giving the second or third measurements are un- likely to negatively affect immunization response

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The End

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