Clinical and Experimental Vaccine Research

  • 제11권1호
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  • Pages.43-52
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  • 2022
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  • 2287-3651(pISSN)
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  • 2287-366X(eISSN)
대한백신학회 (The Korean Vaccine Society)
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Protectivity and safety following recombinant hepatitis B vaccine with different source of bulk compared to hepatitis B (Bio Farma) vaccine in Indonesia

  • 투고 : 2021.09.03
  • 심사 : 2021.11.11
  • 발행 : 2022.01.31
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초록

Purpose: Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine. Materials and Methods: An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject's safety was monitored for 28 days after each vaccination. Results: Of 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines. Conclusion: Investigational vaccines are shown to be equally immunogenic and safe as the control vaccine.

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참고문헌

  1. World Health Organization. Global health sector strategy on viral hepatitis 2016-2021 towards ending viral hepatitis. Geneva: World Health Organization; 2016.
  2. Hepatitis B vaccines: WHO position paper - July 2017. Wkly Epidemiol Rec 2017;92:369-92.
  3. World Health Organization. The immunological basis for immunization series: module 22: hepatitis B. Geneva: World Health Organization; 2011.
  4. Ministry of Health. Infodatin: situasi dan analisis hepatitis [Infodatin: hepatitis situation and analysis]. Jakarta: Ministry of Health; 2014.
  5. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 12th ed. Washington (DC): Public Health Foundation; 2012.
  6. Meeting of the Strategic Advisory Group of Experts on immunization, October 2016: conclusions and recommendations. Wkly Epidemiol Rec 2016;91:561-82.
  7. World Health Organization. Hepatitis B, 2015 July [Internet]. Geneva: World Health Organization; 2015 [cited 2018 May 25]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.
  8. Prijanto M, Handayani S, Julitasari, Sumarno, Siti Mariani S. Immunogenicity & reactogenicity of recombinant DNA hepatitis B (Uniject) Bio Farma Vaccine Study in Bogor. Jakarta: Ministry of Health; 2002.
  9. SMF/Bagian Ilmu Kesehatan Anak RS Hasan Sadikin Bandung. Respon antibody dan kejadian ikutan pasca imunisasi pada bayi baru lahir yang diimunisasi Hepatitis B rekombinan uniject [Antibody response and post-immunization co-occurrence in newborns immunized with uniject recombinant Hepatitis B]. Bandung: Laporan Penelitian; 2002.
  10. Fadlyana E, Gunadi R, Masria S, et al. The immunogenicity and safety of recombinant hepatitis b vaccine (Bio Farma) with two different accelerated schedules in adults. Bandung: Padjadjaran University; 2006.
  11. Fadlyana E, Suryawan N, Tarigan R, Rusmil K, Bachtiar NS. Protectivity and safety following recombinant hepatitis B (Bio Farma) vaccine immunization in late adolescents. Bandung: Padjadjaran University; 2011.
  12. World Health Organization. Causality assessment of an adverse event following immunization. Geneva: World Health Organization; 2013.
  13. World Health Organization. Global manual on surveillance of AEFI. Geneva: World Health Organization; 2014.
  14. World Health Organization. WHO guideline on clinical evaluation of vaccines: regulation expect: technical report series 924. Geneva: World Health Organization; 2004.
  15. Childs L, Roesel S, Tohme RA. Status and progress of hepatitis B control through vaccination in the South-East Asia Region, 1992-2015. Vaccine 2018;36:6-14.
  16. Purwono PB, Juniastuti, Amin M, et al. Hepatitis B virus infection in Indonesia 15 years after adoption of a universal infant vaccination program: possible impacts of low birth dose coverage and a vaccine-escape mutant. Am J Trop Med Hyg 2016;95:674-9.
  17. Hieu NT, Kim KH, Janowicz Z, Timmermans I. Comparative efficacy, safety and immunogenicity of Hepavax-Gene and Engerix-B, recombinant hepatitis B vaccines, in infants born to HBsAg and HBeAg positive mothers in Vietnam: an assessment at 2 years. Vaccine 2002;20:1803-8.
  18. Badan Penelitian dan Pengembangan Kesehatan. Riset kesehatan dasar 2013 [Basic health research 2013]. Jakarta: Kementerian Kesehatan RI; 2013.
  19. Arjmand R, Golami M, Shirvani F, et al. Hepatitis B seroconversion rate after primary immunization series with newly introduced pentavalent vaccine: a report of local study in Alborz province, Iran, 2016. Arch Pediatr Infect Dis 2019;7:3-7.
  20. Kishino H, Takahashi K, Sawata M, Tanaka Y. Immunogenicity, safety, and tolerability of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young Japanese adults. Hum Vaccin Immunother 2018;14:1773-8.
  21. Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One 2013;8:e80409.
  22. Rusmil K, Fadlyana E, Bachtiar NS. Booster vaksinasi hepatitis B terhadap anak yang non responder [Hepatitis B vaccination booster for non-responder children]. Sari Pediatr 2016;12:88-91.
  23. Dahifar H. Immunogenicity of Cuban hepatitis B vaccine in Iranian children. Arch Iran Med 2004;7:89-92.
  24. Kalaivani M, Rastogi S, Kalaiselvan V, Singh GN. Adverse reactions after hepatitis B vaccination: a retrospective analysis using spontaneous reports. J Young Pharm 2017;9:55-9.
  25. Sundoro J, Rusmil K, Sitaresmi MN, et al. Profil keamanan setelah pemberian dosis primer vaksin Pentabio pada bayi di Indonesia [Safety profile following Pentabio primary dose vaccination in Indonesian]. Maj Kedokt Bandung 2017;49:86-93.
  26. Schumacher Z, Bourquin C, Heininger U. Surveillance for adverse events following immunization (AEFI) in Switzerland: 1991-2001. Vaccine 2010;28:4059-64.
  27. Tong NK, Beran J, Kee SA, et al. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney Int 2005;68:2298-303.
  28. Cunha MP, Dorea JG, Marques RC, Leao RS. Vaccine adverse events reported during the first ten years (1998-2008) after introduction in the state of Rondonia, Brazil. Biomed Res Int 2013;2013:853083.
  29. Rusmil K, Gunardi H, Fadlyana E, et al. The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule. BMC Pediatr 2015;15:219.