Pre-clinical immunogenicity and efficacy trial of a recombinant hepatitis E vaccine

Vaccine

Volumn 21, Issue 19-20, 2003, Pages 2607-2615

  Purcell, Robert H ^a   Nguyen, Hanh ^a   Shapiro, Max ^b   Engle, Ronald E ^a   Govindarajan, Sugantha ^c   Blackwelder, William C ^d   Wong, Doris C ^a   Prieels, Jean Paul ^e   Emerson, Suzanne U ^a  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b BIOQUAL INC   (United States)

^c RANCHO LOS AMIGOS NATIONAL REHABILITATION CENTER   (United States)

^d Glaxo SmithKline ^*  (United States)

^e GSK   (Belgium)

Author keywords

Hepatitis E; Monkey; Vaccine

Indexed keywords

HEPATITIS VACCINE; RECOMBINANT HEPATITIS E VACCINE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BLOOD SAMPLING; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG EFFICACY; GENOTYPE; HEPATITIS E; HEPATITIS E VIRUS; IMMUNOGENICITY; NEPAL; NONHUMAN; PRIORITY JOURNAL; RHESUS MONKEY; WORLD HEALTH ORGANIZATION;

EID: 0038330622     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(03)00100-2     Document Type: Article

References (25)

1. Purcell RH, Emerson SU. Hepatitis E virus. In: Knipe D, Howley P, Griffin D, Lamb R, Martin M, Roizman B, et al., editors. Fields virology. 4th ed. Philadelphia (Lippincott): Williams and Wilkins; 2001. p. 3051-61 [chapter 89].
2. Schlauder G.G., Mushahwar I.K. Genetic heterogeneity of hepatitis E virus. J. Med. Virol. 650:2001;282-292.
3. Meng J., Dai X., Chang J.C.et al. Identification and characterization of the neutralization epitope(s) of the hepatitis E virus. Virology. 288:2001;203-211.
4. Schofield D.J., Glamann J., Emerson S.U., Purcell R.H. Identification by phage display and characterization of two neutralizing chimpanzee monoclonal antibodies to the hepatitis E virus capsid protein. J. Virol. 74(12):2000;5548-5555.
5. Tsarev S.A., Tsareva T.S., Emerson S.U., Govindarajan S., Shapiro M., Gerin J.L.et al. Successful passive and active immunization of cynomolgus monkeys against hepatitis E. Proc. Natl. Acad. Sci. U.S.A. 91(21):1994;10198-10202.
6. Zhang M., Emerson S.U., Nguyen H.et al. Recombinant vaccine against hepatitis E: duration of protective immunity in rhesus macaques. Vaccine. 20:2002;3285-3291.
7. Robinson R.A., Burgess W.H., Emerson S.U., Leibowitz R.S., Sosnovtseva S.A., Tsarev S.et al. Structural characterization of recombinant hepatitis E virus ORF2 proteins in baculovirus-infected insect cells. Protein Expr. Purif. 12(1):1998;75-84.
8. Tsarev S.A., Tsareva T.S., Emerson S.U., Govindarajan S., Shapiro M., Gerin J.L.et al. Recombinant vaccine against hepatitis E: dose response and protection against heterologous challenge. Vaccine. 15(17-18):1997;1834-1838.
9. Safary A. Perspectives of vaccination against hepatitis E. Intervirology. 44:2001;162-166.
10. Ticehurst J., Popkin T.J., Bryan J.P., Innis B.L., Duncan J.F., Ahmed A.et al. Association of hepatitis E virus with an outbreak of hepatitis in Pakistan: serologic responses and pattern of virus excretion. J. Med. Virol. 36(2):1992;84-92.
11. Velazquez O., Stetler H.C., Avila C.et al. Epidemic transmission of enterically ransmitted non-A, non-B hepatitis in Mexico, 1986-1987. JAMA. 263:1990;3281-3285.
12. Erker J.C., Desai S.M., Schlauder G.G.et al. A hepatitis E virus variant from the United States: molecular characterization and transmission in cynomolgus macaques. J. Gen. Virol. 80:1999;681-690.
13. Halbur P.G., Kasorndorkbua C., Gilbert C., Guenette D., Potters M.B., Purcell R.H.et al. Comparative pathogenesis of infection of pigs with hepatitis E viruses recovered from a pig and a human. J. Clin. Microbiol. 39(3):2001;918-923.
14. Tsarev S.A., Tsareva T.S., Emerson S.U., Kapikian A.Z., Ticehurst J., London W.et al. ELISA for antibody to hepatitis E virus (HEV) based on complete open-reading frame-2 protein expressed in insect cells: identification of HEV infection in primates. J. Infect. Dis. 168(2):1993;369-378.
15. Ferguson M., Walker D., Mast E., Fields H. Report of a collaborative study to assess the suitability of a reference reagent for antibodies to hepatitis E virus. Biologicals. 30:2002;43-48.
16. Hollander M, Wolfe D. Nonparametric statistical methods. New York: Wiley; 1972.
17. Fisher RA. The design of experiments. Edinburgh: Oliver & Boyd; 1935.
18. Blackwelder W.C. Sample size and power for prospective analysis of relative risk. Stat. Med. 12:1993;691-698.
19. Hollinger B, Emerson SU. Hepatitis A virus. In: Knipe D, Howley P, Griffin D, Lamb R, Martin M, Roizman B, et al. editors, Fields virology. 4th ed. Philadelphia (Lippincott): Williams and Wilkins; 2001. p. 799-840.
20. Purcell R.H., Emerson S.U. Animal models of hepatitis A and E. ILAR J. 42(2):2001;161-177. [review].
21. Zhang M., Emerson S.U., Nguyen H., Engle R.E., Govindarajan S., Gerin J.L.et al. Immunogenicity and protective efficacy of a vaccine prepared from 53 kDa truncated hepatitis E virus capsid protein expressed in insect cells. Vaccine. 20(5-6):2002;853-857.
22. Fuerst TR, Yarbough PO, Zhang Y., et al. Prevention of hepatitis E using a novel ORF-2 subunit vaccine. In: Buisson Y, Coursaget P, Kane M., editors. Enterically-transmitted hepatitis viruses. Tours: La Simarre; 1996. p. 384-92.
23. Tsarev S.A., Tsareva T.S., Emerson S.U., Yarbough P.O., Legters L.J., Moskal T.et al. Infectivity titration of a prototype strain of hepatitis E virus in cynomolgus monkeys. J. Med. Virol. 43(2):1994;135-142.
24. Meng X.J., Halbur P.G., Shapiro M.S., Govindarajan S., Bruna J.D., Mushahwar I.K.et al. Genetic and experimental evidence for cross-species infection by swine hepatitis E virus. J. Virol. 72(12):1998;9714-9721.
25. Clemente-Casares P, Pina S, Buti M, Jardi R, Martin M, Bofill-Mas S, et al. Epidemiological pattern of hepatitis E virus infection in industrialized countries. Emerging Infect Dis 2003; in press.