메뉴 건너뛰기




Volumn 2, Issue 1, 2013, Pages 10-18

Clinical evaluation to confirm the manufacturing consistency of three lots of an adjuvanted glycoprotein D genital herpes vaccine in healthy seronegative pre-teen and adolescent girls: A phase III multi-center double-blind randomized trial

Author keywords

Herpes simplex virus; Immunogenicity; Lot consistency; Safety; Subunit vaccine

Indexed keywords

GLYCOPROTEIN D; HERPES SIMPLEX VIRUS TYPE 2 VACCINE; HERPES VACCINE; UNCLASSIFIED DRUG;

EID: 84876538379     PISSN: None     EISSN: 18794378     Source Type: Journal    
DOI: 10.1016/j.trivac.2013.03.001     Document Type: Article
Times cited : (1)

References (25)
  • 1
    • 54249103516 scopus 로고    scopus 로고
    • An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection
    • A
    • K.J. Looker, G.P. Garnett, and G.P. Schmid An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection Bull. World Health Organ. 86 2008 805 812 A
    • (2008) Bull. World Health Organ. , vol.86 , pp. 805-812
    • Looker, K.J.1    Garnett, G.P.2    Schmid, G.P.3
  • 2
    • 0037108418 scopus 로고    scopus 로고
    • Age-specific prevalence of infection with herpes simplex virus types 2 and 1: A global review
    • J.S. Smith, and N.J. Robinson Age-specific prevalence of infection with herpes simplex virus types 2 and 1: a global review J. Infect. Dis. 186 Suppl. 1 2002 S3 S28
    • (2002) J. Infect. Dis. , vol.186 , Issue.SUPPL. 1
    • Smith, J.S.1    Robinson, N.J.2
  • 6
    • 33747627183 scopus 로고    scopus 로고
    • Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States
    • F. Xu, M.R. Sternberg, B.J. Kottiri, G.M. McQuillan, F.K. Lee, and A.J. Nahmias Trends in herpes simplex virus type 1 and type 2 seroprevalence in the United States JAMA 296 2006 964 973
    • (2006) JAMA , vol.296 , pp. 964-973
    • Xu, F.1    Sternberg, M.R.2    Kottiri, B.J.3    McQuillan, G.M.4    Lee, F.K.5    Nahmias, A.J.6
  • 7
    • 77951244078 scopus 로고    scopus 로고
    • Seroprevalence of herpes simplex virus type 2 among persons aged 14-49 years-United States, 2005-2008
    • Centers for Disease Control and Prevention (CDC)
    • Centers for Disease Control and Prevention (CDC), Seroprevalence of herpes simplex virus type 2 among persons aged 14-49 years-United States, 2005-2008, MMWR Morb Mortal Wkly Rep 59 (2010) 456-459.
    • (2010) MMWR Morb Mortal Wkly Rep , vol.59 , pp. 456-459
  • 8
    • 33847145489 scopus 로고    scopus 로고
    • Synergistic copathogens - HIV-1 and HSV-2
    • L. Corey Synergistic copathogens - HIV-1 and HSV-2 N. Engl. J. Med. 356 2007 854 856
    • (2007) N. Engl. J. Med. , vol.356 , pp. 854-856
    • Corey, L.1
  • 10
    • 29144444035 scopus 로고    scopus 로고
    • Herpes simplex virus 2 infection increases HIV acquisition in men and women: Systematic review and meta-analysis of longitudinal studies
    • E.E. Freeman, H.A. Weiss, J.R. Glynn, P.L. Cross, J.A. Whitworth, and R.J. Hayes Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies AIDS 20 2006 73 83
    • (2006) AIDS , vol.20 , pp. 73-83
    • Freeman, E.E.1    Weiss, H.A.2    Glynn, J.R.3    Cross, P.L.4    Whitworth, J.A.5    Hayes, R.J.6
  • 11
    • 65349157046 scopus 로고    scopus 로고
    • Herpes simplex virus infection in pregnancy and in neonate: Status of art of epidemiology, diagnosis, therapy and prevention
    • E. Anzivino, D. Fioriti, M. Mischitelli, A. Bellizzi, V. Barucca, and F. Chiarini Herpes simplex virus infection in pregnancy and in neonate: status of art of epidemiology, diagnosis, therapy and prevention Virol. J. 6 2009 40
    • (2009) Virol. J. , vol.6 , pp. 40
    • Anzivino, E.1    Fioriti, D.2    Mischitelli, M.3    Bellizzi, A.4    Barucca, V.5    Chiarini, F.6
  • 12
    • 0035680582 scopus 로고    scopus 로고
    • Severe intrauterine herpes simplex disease with placentitis in a newborn of a mother with recurrent genital infection at delivery
    • A. Chatterjee, S.A. Chartrand, C.J. Harrison, A. Felty-Duckworth, and C. Bewtra Severe intrauterine herpes simplex disease with placentitis in a newborn of a mother with recurrent genital infection at delivery J. Perinatol. 21 2001 559 564
    • (2001) J. Perinatol. , vol.21 , pp. 559-564
    • Chatterjee, A.1    Chartrand, S.A.2    Harrison, C.J.3    Felty-Duckworth, A.4    Bewtra, C.5
  • 13
    • 0025845506 scopus 로고
    • Neonatal herpes simplex virus infection in relation to asymptomatic maternal infection at the time of labor
    • Z.A. Brown, J. Benedetti, R. Ashley, S. Burchett, S. Selke, and S. Berry Neonatal herpes simplex virus infection in relation to asymptomatic maternal infection at the time of labor N. Engl. J. Med. 324 1991 1247 1252
    • (1991) N. Engl. J. Med. , vol.324 , pp. 1247-1252
    • Brown, Z.A.1    Benedetti, J.2    Ashley, R.3    Burchett, S.4    Selke, S.5    Berry, S.6
  • 17
    • 0007546917 scopus 로고    scopus 로고
    • European Medicines Agency (accessed June 2012)
    • European Medicines Agency, Note for guidance on the clinical evaluation of vaccines. Available from: < http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003875.pdf > (accessed June 2012).
    • Note for Guidance on the Clinical Evaluation of Vaccines
  • 20
    • 0026092152 scopus 로고
    • Inability of enzyme immunoassays to discriminate between infections with herpes simplex virus types 1 and 2
    • R. Ashley, A. Cent, V. Maggs, A. Nahmias, and L. Corey Inability of enzyme immunoassays to discriminate between infections with herpes simplex virus types 1 and 2 Ann. Intern. Med. 115 1991 520 526
    • (1991) Ann. Intern. Med. , vol.115 , pp. 520-526
    • Ashley, R.1    Cent, A.2    Maggs, V.3    Nahmias, A.4    Corey, L.5
  • 21
    • 0023193290 scopus 로고
    • Statistical considerations in the quantitation of serum immunoglobulin levels using the enzyme-linked immunosorbent assay (ELISA)
    • K.F. Karpinski, S. Hayward, and H. Tryphonas Statistical considerations in the quantitation of serum immunoglobulin levels using the enzyme-linked immunosorbent assay (ELISA) J. Immunol. Methods 103 1987 189 194
    • (1987) J. Immunol. Methods , vol.103 , pp. 189-194
    • Karpinski, K.F.1    Hayward, S.2    Tryphonas, H.3
  • 22
    • 0029000226 scopus 로고
    • A recombinant glycoprotein vaccine for herpes simplex virus type 2: Safety and immunogenicity
    • Erratum, Ann. Intern. Med. 123 (1995) 395
    • A.G. Langenberg, R.L. Burke, S.F. Adair, R. Sekulovich, M. Tigges, and C.L. Dekker A recombinant glycoprotein vaccine for herpes simplex virus type 2: safety and immunogenicity Ann. Intern. Med. 122 1995 889 898 Erratum, Ann. Intern. Med. 123 (1995) 395
    • (1995) Ann. Intern. Med. , vol.122 , pp. 889-898
    • Langenberg, A.G.1    Burke, R.L.2    Adair, S.F.3    Sekulovich, R.4    Tigges, M.5    Dekker, C.L.6
  • 23
    • 0028863993 scopus 로고
    • Automated microneutralization: Method and comparison with Western blot for type-specific detection of herpes simplex antibodies in two pregnant populations
    • S.M. Garland, T.N. Lee, R.L. Ashley, L. Corey, and S.L. Sacks Automated microneutralization: method and comparison with Western blot for type-specific detection of herpes simplex antibodies in two pregnant populations J. Virol. Methods 55 1995 285 294
    • (1995) J. Virol. Methods , vol.55 , pp. 285-294
    • Garland, S.M.1    Lee, T.N.2    Ashley, R.L.3    Corey, L.4    Sacks, S.L.5
  • 24
    • 0001072895 scopus 로고
    • The use of confidence or fiducial limits illustrated in the case of binomial
    • C.J. Clopper, and E.S. Pearson The use of confidence or fiducial limits illustrated in the case of binomial Biometrika 26 1934 404 413
    • (1934) Biometrika , vol.26 , pp. 404-413
    • Clopper, C.J.1    Pearson, E.S.2
  • 25
    • 34248631118 scopus 로고    scopus 로고
    • Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant
    • C. Pedersen, T. Petaja, G. Strauss, H.C. Rumke, A. Poder, and J.H. Richardus Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant J. Adolesc. Health 40 2007 564 571
    • (2007) J. Adolesc. Health , vol.40 , pp. 564-571
    • Pedersen, C.1    Petaja, T.2    Strauss, G.3    Rumke, H.C.4    Poder, A.5    Richardus, J.H.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.