Clinical experience with the inactivated hepatitis A vaccine, Avaxim 80U Pediatric

References

• AVAXIM® Hepatitis A vaccine (inactivated, adsorbed). New Zealand data sheet. 2012 [cited 2018 Sep 18]. Available from: http://products.sanofi.com.au/vaccines/AVAXIM_NZ_PI.pdf
   Google Scholar
• Hadler SC, McFarland L. Hepatitis in day care centers: epidemiology and prevention. Rev Infect Dis. 1986;8:548–557.
   PubMedGoogle Scholar
• WHO. World Health Organization. Technical considerations and case definitions to improve surveillance for viral hepatitis: technical report. 2016 [cited 2018 Sep 18]. Available from: http://apps.who.int/iris/bitstream/10665/204501/1/9789241549547_eng.pdf
   Google Scholar
• Jacobsen KH, Wiersma ST. Hepatitis A virus seroprevalence by age and world region, 1990 and 2005. Vaccine. 2010;28:6653–6657.
   PubMed Web of Science ®Google Scholar
• World Health Organization. WHO position paper on hepatitis A vaccines - June 2012. Wkly Epidemiol Rec. 2012;87:261–276.
   PubMedGoogle Scholar
• Poovorawan Y, Chatchatee P, Chongsrisawat V. Epidemiology and prophylaxis of viral hepatitis: a global perspective. J Gastroenterol Hepatol. 2002;17 Suppl:S155–S166.
   PubMed Web of Science ®Google Scholar
• Gossner CM, Severi E. Three simultaneous, food-borne, multi-country outbreaks of hepatitis A virus infection reported in EPIS-FWD in 2013: what does it mean for the European Union? Euro Surveill. 2014;19:20941.
   PubMedGoogle Scholar
• Averhoff FM, Khudyakov Y, Nelson NP. Hepatitis A vaccines. In: Plotkin SA, Orenstein WA, Offit PA, et al., editors. Vaccines. 7th ed. Philadelphia (PA): Elsevier; 2018. p. 319–341.
   Google Scholar
• Stanaway JD, Flaxman AD, Naghavi M, et al. The global burden of viral hepatitis from 1990 to 2013: findings from the global burden of disease study 2013. Lancet. 2016;388:1081–1088.
   PubMed Web of Science ®Google Scholar
• Suwantika AA, Yegenoglu S, Riewpaiboon A, et al. Economic evaluations of hepatitis A vaccination in middle-income countries. Expert Rev Vaccines. 2013;12:1479–1494.
   PubMed Web of Science ®Google Scholar
• Dhankhar P, Nwankwo C, Pillsbury M, et al. Public health impact and cost-effectiveness of hepatitis A vaccination in the United States: a disease transmission dynamic modeling approach. Value Health. 2015;18:358–367.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Hepatitis A - fact sheet. 2017 [cited 2018 Sep 18]. Available from: http://www.who.int/mediacentre/factsheets/fs328/en/
   Google Scholar
• Jacobsen KH. The global prevalence of hepatitis A virus infection and susceptibility: a systematic review. Geneva: WHO; 2009 [cited 2018 Sep 18]. Available from: http://apps.who.int/iris/bitstream/10665/70180/1/WHO_IVB_1001_eng.pdf
   Google Scholar
• Franco E, Meleleo C, Serino L, et al. Hepatitis A: epidemiology and prevention in developing countries. World J Hepatol. 2012;4:68–73.
   PubMedGoogle Scholar
• Wright R. Viral hepatitis comparative epidemiology. Br Med Bull. 1990;46:548–558.
   PubMed Web of Science ®Google Scholar
• Chen NY, Liu ZH, Shie SS, et al. Clinical characteristics of acute hepatitis A outbreak in Taiwan, 2015–2016: observations from a tertiary medical center. BMC Infect Dis. 2017;17:441.
   PubMed Web of Science ®Google Scholar
• Pham B, Duval B, De Serres G, et al. Seroprevalence of hepatitis A infection in a low endemicity country: a systematic review. BMC Infect Dis. 2005;5:56.
   PubMed Web of Science ®Google Scholar
• Foster M, Ramachandran S, Myatt K, et al. Hepatitis A virus outbreaks associated with drug use and homelessness - California, Kentucky, Michigan, and Utah, 2017. MMWR Morb Mortal Wkly Rep. 2018;67:1208–1210.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Frequently asked questions: hepatitis A outbreaks among people who use drugs and/or people who are homeless in multiple states. 2018 [cited 2019 Jan 21]. Available from: https://www.cdc.gov/hepatitis/outbreaks/FAQs-HepAOutbreaks.html
   Google Scholar
• Wu D, Guo CY. Epidemiology and prevention of hepatitis A in travelers. J Travel Med. 2013;20:394–399.
   PubMed Web of Science ®Google Scholar
• Matheny SC, Kingery JE. Hepatitis A. Am Fam Physician. 2012;86:1027–1034.
   PubMed Web of Science ®Google Scholar
• Plotkin SA, Orenstein WA, Offit PA. Vaccines. 7th ed. 6th ed. Philadelphia (PA): WB Saunders Company; 2012.
   Google Scholar
• World Health Organization. The immunological basis for immunization series: module 18: hepatitis A. World Health Organization, Department of Immunization, Vaccines and Biologicals; 2011 [cited 2018 Sep 18]. Available from: http://apps.who.int/iris/bitstream/10665/44570/1/9789241501422_eng.pdf
   Google Scholar
• Iwarson S, Lindh M, Widerstrom L. Excellent booster response 4 to 8 years after a single primary dose of an inactivated hepatitis A vaccine. J Travel Med. 2004;11:120–121.
   PubMed Web of Science ®Google Scholar
• Hatz C, van der Ploeg R, Beck BR, et al. Successful memory response following a booster dose with a virosome-formulated hepatitis a vaccine delayed up to 11 years. Clin Vaccine Immunol. 2011;18:885–887.
   PubMed Web of Science ®Google Scholar
• Irving GJ, Holden J, Yang R, et al. Hepatitis A immunisation in persons not previously exposed to hepatitis A. Cochrane Database Syst Rev. 2012;7:CD009051.
   PubMed Web of Science ®Google Scholar
• Van Damme P, Banatvala J, Fay O, et al. Hepatitis A booster vaccination: is there a need? Lancet. 2003;362:1065–1071.
   PubMed Web of Science ®Google Scholar
• Baker CJ. Another success for hepatitis A vaccine. N Engl J Med. 2007;357:1757–1759.
   PubMed Web of Science ®Google Scholar
• Flehmig B, Frank H, Frosner GG, et al. Hepatitis A-virus particles in stools of patients from a natural hepatitis outbreak in Germany. Med Microbiol Immunol. 1977;163:209–214.
   PubMed Web of Science ®Google Scholar
• Sanofi Pasteur. Product monograph including patient information - Avaxim® - Pediatric hepatitis A vaccine inactivated. 2015 [cited 2018 Sep 18]. Available from: https://www.vaccineshoppecanada.com/documentcfm?file=avaxim_ped_e.pdf
   Google Scholar
• Dagan R, Greenberg D, Goldenbertg-Gehtman P, et al. Safety and immunogenicity of a new formulation of an inactivated hepatitis A vaccine. Vaccine. 1999;17:1919–1925.
   PubMed Web of Science ®Google Scholar
• Lopez EL, Del Carmen Xifro M, Torrado LE, et al. Safety and immunogenicity of a pediatric formulation of inactivated hepatitis A vaccine in Argentinean children. Pediatr Infect Dis J. 2001;20:48–52.
   PubMed Web of Science ®Google Scholar
• Lolekha S, Pratuangtham S, Punpanich W, et al. Immunogenicity and safety of two doses of a paediatric hepatitis A vaccine in thai children: comparison of three vaccination schedules. J Trop Pediatr. 2003;49:333–339.
   PubMed Web of Science ®Google Scholar
• Yurdakök K, Bakir M, Ince T, et al. Immunogenicity and safety of an inactivated hepatitis A vaccine given with measles-mumps-rubella vaccine to 12–13 month old Turkish children. J Vaccines Vaccin. 2012;3:1000146.
   Google Scholar
• Li RC, Li Y, Yi N, et al. An open, prospective, randomized study comparing the immunogenicity and safety of two inactivated hepatitis A pediatric vaccines in toddlers, children and adolescents in China. Pediatr Infect Dis J. 2013;32:e77–e81.
   PubMed Web of Science ®Google Scholar
• Crevat D, Brion JD, Gailhardou S, et al. First experience of concomitant vaccination against dengue and MMR in toddlers. Pediatr Infect Dis J. 2015;34:884–892.
   PubMed Web of Science ®Google Scholar
• Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, et al. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2-to 5-year-olds and Naive 12-to 24-month-olds multicenter randomized controlled trial. Pediatr Infect Dis J. 2010;29:1111–1117.
   PubMed Web of Science ®Google Scholar
• Feroldi E, Pancharoen C, Kosalaraksa P, et al. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12–18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012;8:929–937.
   PubMed Web of Science ®Google Scholar
• Espu C, Benedetti L, Cuello H, et al. Persistence of immunity from 1 year of age after one or two doses of hepatitis A vaccine given to children in Argentina. Hepat Med. 2012;4:53–60.
   PubMedGoogle Scholar
• Espul C, Benedetti L, Linares M, et al. Five-year follow-up of immune response after one or two doses of inactivated hepatitis A vaccine given at 1 year of age in the Mendoza Province of Argentina. J Viral Hepat. 2015;22:453–458.
   PubMed Web of Science ®Google Scholar
• Abarca K, Ibanez I, Perret C, et al. Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. Int J Infect Dis. 2008;12:270–277.
   PubMed Web of Science ®Google Scholar
• Celebi S, Hacimustafaoglu MK, Albayrak Y, et al. Assessment of immune responses to hepatitis A vaccination in children aged 1 and 2 years. Turk J Med Sci. 2013;43:617–624.
   Web of Science ®Google Scholar
• Dagan R, Greenberg D, Weber F. Immunogenicity of an inactivated hepatitis A pediatric vaccine: three-year post-booster follow-up. Vaccine. 2005;23:5144–5148.
   PubMed Web of Science ®Google Scholar
• Lagos R, Munoz A, Dumas R, et al. Immunological priming of one dose of inactivated hepatitis A vaccine given during the first year of life in presence of maternal antibodies. Vaccine. 2003;21:3730–3733.
   PubMed Web of Science ®Google Scholar
• Lopez EL, Contrini MM, Xifro MC, et al. Hepatitis A vaccination of Argentinean infants: comparison of two vaccination schedules. Vaccine. 2007;25:102–108.
   PubMed Web of Science ®Google Scholar
• Lopez EL, Contrini MM, Mistchenko A, et al. Long-term immunity after two doses of inactivated hepatitis A vaccine, in Argentinean children. Pediatr Infect Dis J. 2010;29:568–570.
   PubMed Web of Science ®Google Scholar
• Lopez EL, Contrini MM, Mistchenko A, et al. Modeling the long-term persistence of hepatitis A antibody after a two-dose vaccination schedule in Argentinean children. Pediatr Infect Dis J. 2015;34:417–425.
   PubMed Web of Science ®Google Scholar
• Soysal A, Gokce I, Pehlivan T, et al. Interchangeability of a hepatitis A vaccine second dose: Avaxim 80 following a first dose of Vaqta 25 or Havrix 720 in children in Turkey. Eur J Pediatr. 2007;166:533–539.
   PubMed Web of Science ®Google Scholar
• Yoon SH, Kim HW, Ahn JG, et al. Reappraisal of the immunogenicity and safety of three hepatitis A vaccines in adolescents. J Korean Med Sci. 2016;31:73–79.
   PubMed Web of Science ®Google Scholar
• Fisenka EG, Germanovich FA, Glinskaya IN, et al. Effectiveness of universal hepatitis A immunization of children in Minsk City, Belarus: four-year follow-up. J Viral Hepat. 2008;15:57–61.
   PubMed Web of Science ®Google Scholar
• Zuckerman J, Peyron F, Wallon M. Comparison of the safety and immunogenicity of two inactivated hepatitis A. Adv Ther. 1997;14:116–124.
   Web of Science ®Google Scholar
• Espul C, Benedetti L, Linares M, et al. Seven-year follow-up of the immune response after one or 2 doses of inactivated hepatitis A vaccine given at 1 year of age in the Mendoza Province of Argentina. Hum Vaccin Immunother. 2017;13:2707–2712.
   PubMed Web of Science ®Google Scholar
• Zhou W, Pool V, Iskander JK, et al. Surveillance for safety after immunization: vaccine adverse event reporting system (VAERS)–United States, 1991–2001. MMWR Surveill Summ. 2003;52:1–24.
   PubMedGoogle Scholar
• Theeten H, Van Herck K, Van Der Meeren O, et al. Long-term antibody persistence after vaccination with a 2-dose Havrix (inactivated hepatitis A vaccine): 20 years of observed data, and long-term model-based predictions. Vaccine. 2015;33:5723–5727.
   PubMed Web of Science ®Google Scholar
• Vidor E, Dumas R, Porteret V, et al. Aventis pasteur vaccines containing inactivated hepatitis A virus: a compilation of immunogenicity data. Eur J Clin Microbiol Infect Dis. 2004;23:300–309.
   PubMed Web of Science ®Google Scholar
• Mayorga O, Buhler S, Jaeger VK, et al. Single-dose hepatitis A immunization: 7.5-year observational pilot study in Nicaraguan children to assess protective effectiveness and humoral immune memory response. J Infect Dis. 2016;214:1498–1506.
   PubMed Web of Science ®Google Scholar
• Melgaco JG, Morgado LN, Santiago MA, et al. A single dose of inactivated hepatitis A vaccine promotes HAV-specific memory cellular response similar to that induced by a natural infection. Vaccine. 2015;33:3813–3820.
   PubMed Web of Science ®Google Scholar
• Cervio G, Trentadue J, D’Agostino D, et al. Decline in HAV-associated fulminant hepatic failure and liver transplant in children in Argentina after the introduction of a universal hepatitis A vaccination program. Hepat Med. 2011;3:99–106.
   PubMedGoogle Scholar
• Vacchino MN. Incidence of Hepatitis A in Argentina after vaccination. J Viral Hepat. 2008;15 Suppl 2:47–50.
   PubMed Web of Science ®Google Scholar
• Connor BA. Hepatitis A vaccine in the last-minute traveler. Am J Med. 2005;118 Suppl 10A:58S–62S.
   PubMed Web of Science ®Google Scholar
• National Advisory Committee on Immunization (NACI). Update on the recommended use of hepatitis A vaccine. 2016 [cited 2018 Jul 13]. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/update-recommended-use-hepatitis-vaccine.html
   Google Scholar
• National Foundation for Infectious Diseases. Meeting archive: updates from February 2018 ACIP meeting. [cited 2018 Jul 13]. Available from: https://cc.readytalk.com/cc/s/meetingArchive?eventId=y8begst0letz
   Google Scholar
• Centers for Disease Control and Prevention. Advisory committee on immunization practices (ACIP): ACIP recommendations. 2018 [cited 2019 Jan 21]. Available from: https://www.cdc.gov/vaccines/acip/recommendations.html
   Google Scholar
• Bell BP, Negus S, Fiore AE, et al. Immunogenicity of an inactivated hepatitis A vaccine in infants and young children. Pediatr Infect Dis J. 2007;26:116–122.
   PubMed Web of Science ®Google Scholar
• Stojanov S, Liese JG, Belohradsky BH, et al. Administration of hepatitis A vaccine at 6 and 12 months of age concomitantly with hexavalent (DTaP-IPV-PRP approximately T-HBs) combination vaccine. Vaccine. 2007;25:7549–7558.
   PubMed Web of Science ®Google Scholar
• Sharapov UM, Bulkow LR, Negus SE, et al. Persistence of hepatitis A vaccine induced seropositivity in infants and young children by maternal antibody status: 10-year follow-up. Hepatology. 2012;56:516–522.
   PubMed Web of Science ®Google Scholar
• Spradling PR, Bulkow LR, Negus SE, et al. Persistence of seropositivity among persons vaccinated for hepatitis A during infancy by maternal antibody status: 15-year follow-up. Hepatology. 2016;63:703–711.
   PubMed Web of Science ®Google Scholar