Cengiz YAKINCI, Sabit ŞAHİN, Yaşar DURMAZ

Düşük doz hepatit B aşısının kas içi, deri altı veya deri içi uygulaması sonucu gelişen anti-HBs antikor titrelerinin karşılaştırılması

Amaç: Dünya’da 300 milyon Hepatit B virusu (HBV) taşıyıcısı olduğu ve bunların %25-30’unun Siroz veya Primer Hepatosellüler Karsinoma (PHK) nedeniyle kaybedildiği kabul edilmektedir. Bundan dolayı HBV’ne karşı tüm dünyada universal aşılama önerilmektedir. Ancak aşı maliyetinin yüksek olması yaygın kullanımını kısıtlamaktadır. Yüksek maliyeti azaltma yollarından biri de düşük dozlarda aşı uygulamasıdır. Bu çalışmanın amacı düşük doz Hepatit B aşısını üç değişik yolan uygulayarak elde edilen Anti-HBs antikor titrelerini karşılaştırmaktır. Gereç ve yöntem: Bu çalışmada, rekombinant HB aşısının intramuskuler (IM), subkutan (SK) veya intradermal (ID) değişik dozlarda (4.10 veya 20 μg) 3 kez uygulanması ile oluşan antikor titrelerinin değerlendirildi. Bulgular: HBsAg negatif anneden doğan, ağırlığı >2500 gram olan 96 yenidoğan bebek rastgele 7 gruba ayrıldı. İntramüsküler 20 μg (IM20) 15, IM 10 μg (IM10) 18, IM 4 μg (IM4) 12, SK 20 μg 12, SK 10 μg 14, SK 4 μg 10 ve ID 4 μg 15 bebeğe 0, 1 ve 6. aylarda rekombinant HB aşısı (20 μg /0.5 ml. Gen-Hevac B. Pasteur Merieux) uygulandı. Üçüncü dozdan 6 ay sonra ilk dört gurupta elde edilen koruyucu antikor titreleri (sırasıyla %100, %93.4, %91.6 ve %88.9) bulundu ve yeterli kabul edildi. Sonuç: Sonuç olarak ID yoldan düşük doz (4 μg) HB aşısı uygulamasının immün yanıtı azaltmadan maliyeti 5 kat azaltarak istenilen bağışıklama düzeyleri sağladığını söyleyebiliriz. . Klin Deney Ar Derg 2011; 2 (3): 277-281.

The comparison of antibody titers secondary to intramuscularly, subcutaneous or intradermal application of low dose Hepatitis B vaccine

Objectives: There are approximately 300 million HBV carriers where 25-30% of them had deceased due to cirrhosis or PHK. Universal vaccination is suggested worldwide against HBV because it is proven that vaccinating only the risk group is useless to reduce or eradicate the HB. However, the high costs limit its extensive usage. One way to reduce high costs is vaccinating in low dose. The purpose of this study is to determine the dependable, effective and low-cost dose as the result of evaluating the antibody titers against recombinant HB vaccine in three routes. Materials and methods: Antibody titers against three times intramuscularly (IM), subcutaneous (SC) and intradermal (ID) in different doses like 4μg, 10μg or 20μg were detected. Results: Totally, 96 newborn were chosen from HBsAg negative mothers and greater than 2500 gram in birth weight. They were randomly distributed into 7 groups. The recombinant HB vaccine (20 μg/0.5 ml. Gen-Hevac B. Pasteur Merieux) is applied as IM 20 μg (IM20) to 15, IM 10 μg (IM10) to 18, IM4μg (IM4) to 12, SC 20 μg to 12, SC 10 μg to 14, SC 4 μg to 10 and finally IM 4 μg to 15 babies after birth, at first month and sixth month. Six month after the third dose, the protective antibody titers gathered from the first four groups (100%, 93.4%, 91.6%, and 88.9% respectively) are accepted as sufficient. Conclusion: The application of low dose (4 pg) Hepatitis-B Vaccine via intradermal resulted in desired immunization level without reducing immune response and by reducing the cost five times. J Clin Exp Invest 2011; 2 (3): 277-281.

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1. Dienstag JL, Wands JR, Isselbacher KJ. Acute Hepatitis. In: Braunwald E, Isselbacher KJ, Petersdorf RG, Wilson JD, Adams RD, ed(s). Principles of Internal Medicine 12. ed. New York: McGraw-Hill 1991: 1322-33.
2. Jawetz E, Melnick JL, Adelberg EA, et al. Hepatitis Viruses. In: Jawetz E, Melnick JL, Adelberg EA, Brooks GF, Butel JS. Nicholas Ornston L, ed(s). Medical Microbiology, 18th ed. Norwalk: Appleton Lange 1989: 419-32.
3. Kılıçturgay K, Mistik R. Türkiye’de Viral Hepatitler. In: Kılıçturgay K, ed. Viral hepatit’94. Istanbul: Nobel Tip Kitabevi 1994: 1-14.
4. Woodruff BA. Stevenson J, Yusuf H, et al. Progress toward integrating hepatitis B vaccine into routine infant immunization schedules in the United States, 1991 Through 1994. Pediatrics 1996; 97 (6): 798-803.
5. Hurie MB, Saari TN, Proctor ME, et al Hospitals’ responses to universal infant hepatitis B vaccination recommendations. Pediatrics 1995; 96 (5): 875-9.
6. Sümbüloğlu K ve sümbüloğlu V. Biyoistatistik. Ankara: Özdemir Yayıncılık, 1993; 76-162
7. Chiaramonte M. Majori S, Ngatchu T, 1996; 14 (2): 135-7.
8. Balık 1. Hepatit B Epidemiyolojisi In: Kılıçturgay K Ed. Viral hepatit’94. Istanbul: Nobel Tip Kitabevi 1994: 91-101.
9. Kuru Ü, Turan Ö, Kum N, ve ark Results of vaccinated infants born to HBsAg- positive mothers with different hepatitis B vaccines and doses. Turk J Pediatrics 1995; 37(2): 93-102.
10. Olgun N. İzmir yöresinde HBV’nun perinatal geçiş sıklığı. İnfeksiyon Dergisi 1991; 5(2): 117-20.
11. Tekeli E, Balık İ, Kurt H, et al. Intramuscular and intradermal administration of a recombinant hepatitis B vaccine. Türkiye Tıp Dergisi 1995;2(2):127-30.
12. Coleman PJ, Shaw Jr FE, Serovich J, et al. Intradermal hepatitis B vaccination in a large hospital employee population. Vaccine 1991; 9(6): 723-7.
13. Bryan JP, Sjogren M, Iqbal M, et al. Comparative trial of low-dose, intradermal, recombinnt and plasma derived hepatitis B vaccines. J Infec Dis 1990; 162(6): 789-93.
14. Mahoney FJ. Lawrance M, Scott C, et al. Continuing risk for hepatitis B transmission among Southeast Asian infants in Louisiana. Pediatrics 1995; 96 (6): 1113-6.
15. Santagostino E, Mannucci PM, Gringeri A, et al. Accelareted schedule of hepatitis B vaccination in patients with hemophilia. J Med Virology 1993; 41: 95-8.
16. Wahl M, Hermodsson S. Intradermal, subcutaneous or intramusculer administration of hepatitis B vaccine: Side effects and antibody response. Scand J Infect Dis 1987; 19(5): 617-21.
17. Leonardi S, Leggio T, Fischer A, et al. Intradermal hepatitis B vaccination: efficacy and timing for a booster dose in infants at risk. Pediatr Infect Dis J 1989; 8(3): 337-9.
18. Fadda G, Maida A, Masia C, et al. Efficacy of hepatitis B immunization with reduced intradermal doses. Eur J Epidemiol 1987; 3(2): 176-80.
19. Flayashi J, Kashiwagi S, Noguchi A. et al. Intradermal hepatitis B vaccination for mentally retarded patients. J Infect 1989; 19(2): 119-25.
20. Milne A, Allwood GK, Pearce NE, et al. Low dose hepatitis B vaccination in children. N Z Med J 1986; 99(1): 47-9.
21. Whittle HC, Lamb WH and Ryder RW Trials of intradermal hepatitis B vaccines in Gambian children. Ann Trop Pediatr 1987; 7(1): 6-9.
22. Gonzales IVEL, Usandizaga M, Alomar P, et al. Intradermal and intramuscular route for vaccination against hepatitis B. Vaccine 1990; 8(4): 402-5.
23. Monis CA, Olver PR, Reynolds F, et al. Intradermal hepatitis B immunization: Serological response by age and sex. Epidemiol Infect 1989; 103(3); 387-94.