Volume 74, Issue 2
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645


The heat stability of hepatitis B vaccine (HepB vaccine) should enable its storage outside the cold chain (OCC), increasing access to the birth dose in areas lacking refrigeration. We compared the immunogenicity of a locally produced vaccine among infants who received three doses stored within the cold chain (n = 358) or for whom the first dose was stored OCC for up to one month (n = 748). Serum was collected from these infants at age 9–18 months. The vaccine was protective in 80.3% of all infants. There were no differences in the prevalence of a protective level of antibody or antibody titer among groups of infants according to storage strategy. Differences in antibody titer between certain groups of infants could be explained by different vaccination schedules. Where birth dose coverage will be improved, HepB vaccine can be taken OCC for up to one month without affecting its immunogenicity.


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  1. World Health Organisation, 1992. Expanded program on immunization. Global Advisory Group–Part 1. Wkly Epidemiol Rec 67 : 11–15. [Google Scholar]
  2. Hipgrave DB, Nyugen TV, Vu NH, Hoang TL, Do TD, Tran NT, Jolley D, Maynard JE, Biggs BA, 2003. Hepatitis B infection in rural Vietnam and the implications for a national program of infant immunization. Am J Trop Med Hyg 69 : 88–94. [Google Scholar]
  3. Tran VB, Buu M, Nguyen TM, Morris GE, 1993. Hepatitis B in Ho Chi Minh City, Viet Nam. Trans R Soc Trop Med Hyg 87 : 262. [Google Scholar]
  4. Nakata S, Song P, Duc DD, Nguyen XQ, Murata K, Tsuda F, Okamoto H, 1994. Hepatitis C and B virus infections in populations at low or high risk in Ho Chi Minh and Hanoi, Vietnam. J Gastroenterol Hepatol 9 : 416–419. [Google Scholar]
  5. Katelaris PH, Robertson G, Bradbury R, Tippett G, Hoa DQ, Ngu MC, 1995. Seroprevalence of hepatitis viruses in children in rural Viet Nam. Trans R Soc Trop Med Hyg 89 : 487. [Google Scholar]
  6. Vietnam Demographic and Health Survey, 2002. Calverton, MD: Committee for Population, Family and Children (Vietnam) and ORC Macro., 2003.
  7. Anonymous, 1991. Hepatitis B vaccine delivery outside the cold chain: the Long An County, China example. Global Perspectives Hepatitis 2 : 3–4. [Google Scholar]
  8. Sutanto A, Suarnawa IM, Nelson CM, Stewart T, Soewarso TI, 1999. Home delivery of heat-stable vaccines in Indonesia: outreach immunization with a prefilled, single-use injection device. Bull World Health Organ 77 : 119–126. [Google Scholar]
  9. Otto BF, Suarnawa IM, Stewart T, Nelson C, Ruff TA, Widjaya A, Maynard JE, 1999. At-birth immunisation against hepatitis B using a novel pre-filled immunisation device stored outside the cold chain. Vaccine 18 : 498–502. [Google Scholar]
  10. Diminsky D, Moav N, Gorecki M, Barenholz Y, 2000. Physical, chemical and immunological stability of CHO-derived hepatitis B surface antigen (HBsAg) particles. Vaccine 18 : 3–17. [Google Scholar]
  11. Just M, Berger R, 1988. Immunogenicity of a heat-treated recombinant DNA hepatitis B vaccine. Vaccine 6 : 399–400. [Google Scholar]
  12. van Damme P, Cramm M, Safary A, Vandepapeliere P, Meheus A, 1992. Heat stability of a recombinant DNA hepatitis B vaccine. Vaccine 10 : 366–367. [Google Scholar]
  13. Galazka A, Milstien J, Zaffram M, 1998. Thermostability of Vaccines. Global Programme for Vaccines and Immunization. Geneva: World Health Organization. WHO/GPV/98.07.
  14. Hadler SC, de Monzon MA, Lugo DR, Perez M, 1989. Effect of timing of hepatitis B vaccine doses on response to Vaccine in Yucpa Indians. Vaccine 7 : 106–110. [Google Scholar]
  15. West DJ, 1993. Scope and design of hepatitis B vaccine clinical trials. Ellis RW, ed. Hepatitis B Vaccines in Clinical Practice. New York: Dekker Inc., 159–178.
  16. Moulia-Pelat JP, Spiegel A, Martin PM, Cardines R, Boutin JP, Roux JF, Excler JL, Saliou P, 1994. A 5-year immunization field trial against hepatitis B using a Chinese hamster ovary cell recombinant vaccine in French Polynesian newborns: results at 3 years. Vaccine 12 : 499–502. [Google Scholar]
  17. Honorati MC, Palareti A, Donzani D, Busachi CA, Rizzoli R, Facchini A, 1999. A mathematical model predicting anti-HBs decay after vaccination against hepatitis B. Clin Exp Immunol 116 : 121–126. [Google Scholar]
  18. Mast E, Mahoney F, Kane M, Margolis H, 2004. Hepatitis B vaccine. Plotkin S, Orenstein W, Offit P, eds. Vaccines. Fourth edition. Philadelphia: W. B. Saunders Co., 299–337.
  19. Lo KJ, Tsai YT, Lee SD, Wu TC, Wang JY, Chen GH, Yeh CL, Chiang BN, Yeh SH, Goudeau A, Coursaget P, Tong MJ, 1985. Immunoprophylaxis of infection with hepatitis B virus in infants born to hepatitis B surface antigen-positive carrier mothers. J Infect Dis 152 : 817–822. [Google Scholar]
  20. Andre FE, Zuckerman AJ, 1994. Review: protective efficacy of hepatitis B vaccines in neonates. J Med Virol 44 : 144–151. [Google Scholar]
  21. Department of Vaccines and Biologicals, 2002. Getting Started with Vaccine Vial Monitors. Geneva: World Health Organization. WHO/V&B/02.35.

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  • Received : 26 Apr 2005
  • Accepted : 09 Sep 2005

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