1921
Volume 72, Issue 2
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

We conducted a randomized, double-blind, phase III yellow fever (YF) vaccine trial among 1,107 healthy children in Sullana in northern Peru. The safety and efficacy (by measurement of geometric mean neutralizing antibody titer responses) were determined for two YF vaccines, ARILVAX™ (n = 738) and YF-VAX® (n = 369). Serocon-version rates were higher (94.9%) in ARILVAX™ than in YF-VAX® (90.6%) recipients. The two-sided 95% confidence interval (YF-VAX®–ARILVAX™) was (-12.8% to -2.5%), indicating that the higher seroconversion rate for Arilvax™ was significant. Post-vaccination (30-day) mean log neutralization indices were found to be similar for both products: 1.32 for ARILVAX™ and 1.26 for YF-VAX® ( = 0.1404, by analysis of variance). A similar number of subjects in each group reported at least one adverse event (AE); 441 (59.8%) for ARILVAX™ versus 211 (59.9%) for YF-VAX®. Most (591; 96.7%) of these were of a mild nature and resolved without treatment. There were no treatment-related serious AEs. This is the first randomized, double-blind comparison of two YF vaccines in a pediatric population; both vaccines were shown to be highly immunogenic and well-tolerated.

Loading

Article metrics loading...

/content/journals/10.4269/ajtmh.2005.72.189
2005-02-01
2017-11-21
Loading full text...

Full text loading...

/deliver/fulltext/14761645/72/2/0720189.html?itemId=/content/journals/10.4269/ajtmh.2005.72.189&mimeType=html&fmt=ahah

References

  1. Monath TP, 2003. Yellow fever. Plotkin SA, Orenstein WA, eds. Vaccines. Fourth edition. Philadelphia: W. B. Saunders, 1095–1176.
  2. Monath TP, 2001. Yellow fever: an update. Lancet Infect Dis 1 : 11–20.
  3. Robertson SE, Hull BP, Tomori O, Bele O, Leduc JW, Esteves K, 1996. Yellow fever: a decade of reemergence. JAMA 276 : 1157–1162.
  4. Monath TP, Cetron M, 2002. Prevention of yellow fever in persons traveling to the tropics. Clin Infect Dis 34 : 1369–1378.
  5. Theiler M, 1951, The virus. Strode GK, ed. Yellow Fever. New York: McGraw Hill, 46–136.
  6. Monath TP, Nichols R, Archambault WT, Moore L, Marchesani R, Tian J, Shope RE, Thomas N, Schrader R, Furby D, Bedford P, 2002. Comparative safety and immunogenicity of two yellow fever 17D vaccines (ARILVAX™ and YF-VAX®) in a phase III multicenter, double-blind clinical trial. Am J Trop Med Hyg 66 : 533–541.
  7. Freestone DS, Ferris RD, Weinberg A, Kelly A, 1977. Stabilized 17D strain yellow fever vaccine: dose response studies, clinical reactions and effects on hepatic function. J Biol Stand 5 : 181–186.
  8. Moss-Blundell AJ, Berstein S, Shepherd WM, Langford DT, Ferris R, Kelly A, 1981. A clinical study of stabilized 17D strain live attenuated yellow fever vaccine. J Biol Stand 9 : 445–452.
  9. Cerna Iparraguirre FJ, 2000. EPI Directive No. 002-10-00. Lima, Peru: Ministry of Health, Division of General Person’s Health (DGSP); Maternal and Child Health Program’s Executive Office, Immunizations Subprogram.
  10. Bryant J, Wang H, Cabezas C, Ramirez G, Watts D, Russell K, Barrett A, 2003. Enzootic transmission of yellow fever virus in Peru. Emerg Infect Dis 9 : 926–933.
  11. Carter K, 1998. Vectorial control of Aedes aegypti for the prevention of urban yellow fever. Carrillo C, Cabezas C, eds. Reunion de Expertos: Estrategias de Prevencion y Control de la Fiebre Amarilla y Riesgo de Urbanizacion en las Americas. May 14–15, 1998. Lima, Peru: U.S. Agency for International Development and Immigration and Naturalization Service.
  12. World Health Organization, 1998. WHO Expert Committee on Biological Standardization. World Health Organ Tech Rep Ser 872 : 31–72. Available from URL:http://www.who.int/biologicals/ECBS/Reports.htm.
  13. Monath TP, Kinney RM, Schlesinger JJ, Brandriss MW, Bres P, 1983. Ontogeny of yellow fever 17D vaccine: RNA oligonucleotide fingerprint and monoclonal antibody analyses of vaccines produced worldwide. J Gen Virol 64 : 627–637.
  14. Pugachev KV, Ocran SW, Guirakoo F, Furby D, Monath TP, 2001. Heterogeneous nature of the genome of the ARILVAX yellow fever 17D vaccine revealed by consensus sequencing. Vaccine 20 : 996–999.
  15. Mason RA, Tauraso NM, Spertzel RO, Ginn RK, 1973. Yellow fever vaccine: direct challenge of monkeys given graded doses of 17D vaccine. Appl Microbiol 25 : 539–544.
  16. Spector S, Tauraso NM, 1968. Yellow fever virus. 1. Development and evaluation of a plaque neutralizing test. Appl Microbiol 16 : 1770–1775.
  17. World Health Organization, 1993. The Immunological Basis for Immunization. Yellow Fever. Geneva: WHO. Publication no. (WHO/EPI/GEN) 93.18, 1–13. Available from URL: http://www.who.ch/programmes/gpv/gEnglish/avail/gpvcatalog1.htm.
  18. Poland JD, Calisher CH, Monath TP, Murphy K, Downs WG, 1981. Persistence of neutralizing antibody 30–35 years after immunization with 17D yellow fever vaccine. Bull World Health Organ 59 : 895–900.
  19. Fox JP, Cabral AS, 1943. The duration of immunity following vaccination with the 17D strain of yellow fever virus. Am J Hyg 37 : 93–120.
  20. Pond WL, Ehrenkranz NJ, Danauskas JX, Carter MJ, 1967. Heterotypic serologic responses after yellow fever vaccination; detection of persons with past St. Louis encephalitis or dengue. J Immunol 98 : 673–682.
  21. Theiler M, Anderson CR, 1975. The relative resistance of dengue-immune monkeys to yellow fever virus. Am J Trop Med Hyg 24 : 115–117.
  22. Monath TP, 1989. The absence of yellow fever in Asia – cause for concern? Virus Information Exchange Newsletter Southeast Asia West Pacif 6 : 106–107.
  23. Anonymous, 1966. Fatal viral encephalitis following 17D yellow fever vaccine inoculation. Report of a case in a 3-year-old child. JAMA 198 : 671–672.
  24. Kelso JM, Mootrey GT, Tsai TF, 1999. Anaphylaxis from yellow fever vaccine. J Allergy Clin Immunol 103 : 698–701.
  25. Martin M, Weld LH, Tsai TF, Mootrey GT, Chen RT, Niu M, Cetron MS, and The Geosentinel Yellow Fever Working Group, 2001. Advanced age as a risk factor for illness temporally associated with yellow fever vaccination. Emerg Infect Dis 7 : 945–951.
  26. Vasconcelos PFC, Luna EJ, Galler R, Silva LJ, Coimbra TL, Barros VLRS, Monath TP, Rodrigues SG, Laval C, Costa ZG, Vilela MFG, Santos CLS, Papaiordanou CMO, Alves VAF, Andrade LD, Sato HK, Rosa EST, Froguas GB, Lacava E, Almeida LMR, Cruz ACR, Rocco IM, Santos RTM, Oliva OFP, and The Brazilian Yellow Fever Vaccine Evaluation Group, 2001. Serious adverse events associated with 17DD vaccine in Brazil: a report of two cases. Lancet 358 : 91–97.
  27. Kitchener S, 2004. Viscerotropic and neurotropic disease following vaccination with the yellow fever 17D vaccine ARILVAX®. Vaccine 22 : 2103–2105.
  28. Barwick RS, Marfin AA, Cetron MS, 2004. Yellow fever vaccine-associated disease. Scheld WM, Murray BE, Hughes JM, eds. Emerging Infections. Sixth edition. Washington, DC: American Society for Microbiology Press, ASM Press, 25–34.
http://instance.metastore.ingenta.com/content/journals/10.4269/ajtmh.2005.72.189
Loading
/content/journals/10.4269/ajtmh.2005.72.189
Loading

Data & Media loading...

  • Received : 09 Jun 2004
  • Accepted : 17 Aug 2004

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error