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Volumn 13, Issue 2, 2013, Pages 95-104

Ethical tradeoffs in trial design: Case study of an HPV vaccine trial in HIV-infected adolescent girls in lower income settings

Author keywords

Clinical trials; Public health; Research ethics; Standard of care; Vaccines

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN PAPILLOMAVIRUS;

EID: 84880842815     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/dewb.12028     Document Type: Article
Times cited : (3)

References (47)
  • 1
    • 0028003766 scopus 로고
    • Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group
    • E.M. Connor, R.S. Sperling, R. Gelber etal. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. NEJM 1994; 331: 1173-1180.
    • (1994) NEJM , vol.331 , pp. 1173-1180
    • Connor, E.M.1    Sperling, R.S.2    Gelber, R.3
  • 2
    • 0030767808 scopus 로고    scopus 로고
    • Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries
    • P. Lurie & S.M. Wolfe. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. NEJM 1997; 337: 853-856.
    • (1997) NEJM , vol.337 , pp. 853-856
    • Lurie, P.1    Wolfe, S.M.2
  • 5
    • 84880824214 scopus 로고    scopus 로고
    • A Study that Should Not Have Been Done
    • Bioethics Forum, Hastings Center Report, Available at:, [Accessed 14 Feb 2013].
    • S. Philpott & U. Schuklenk. A Study that Should Not Have Been Done. Bioethics Forum, Hastings Center Report 2010; 41: 3, Available at: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4626&bl ogid=140. [Accessed 14 Feb 2013].
    • (2010) , vol.41 , pp. 3
    • Philpott, S.1    Schuklenk, U.2
  • 6
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • E.J. Emanuel, D. Wendler & C. Grady. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 7
    • 84880816246 scopus 로고    scopus 로고
    • CDC. HPV Vaccine Information for Young Women - Fact Sheet (17 July ). Available at:, [Accessed 14 Feb 2013].
    • CDC. HPV Vaccine Information for Young Women - Fact Sheet (17 July 2012). Available at: http://www.cdc.gov/std/hpv/stdfact-hpv-vaccine-young-women.htm [Accessed 14 Feb 2013].
    • (2012)
  • 8
    • 63449124871 scopus 로고    scopus 로고
    • Vaccination in the immunocompromised child: a probe of immune reconstitution
    • M.J. Abzug. Vaccination in the immunocompromised child: a probe of immune reconstitution. PIDJ 2009; 28: 233-236
    • (2009) PIDJ , vol.28 , pp. 233-236
    • Abzug, M.J.1
  • 9
    • 84855461572 scopus 로고    scopus 로고
    • Safety and immunogenicity of quadrivalent meningococcal conjugate vaccine in 2- to 10-year-old human immunodeficiency virus-infected children
    • G.K. Siberry, M.G. Warshaw, P.L. Williams, etal. Safety and immunogenicity of quadrivalent meningococcal conjugate vaccine in 2- to 10-year-old human immunodeficiency virus-infected children. PIDJ 2012; 31: 47-52
    • (2012) PIDJ , vol.31 , pp. 47-52
    • Siberry, G.K.1    Warshaw, M.G.2    Williams, P.L.3
  • 10
    • 33847793464 scopus 로고    scopus 로고
    • Long-term immunogenicity and efficacy of a 9-valent conjugate pneumococcal vaccine in human immunoedeficient virus infected and non-infected children in the absence of a booster dose of vaccine
    • S.A. Madhi, P. Adrian, L. Kuwanda, etal. Long-term immunogenicity and efficacy of a 9-valent conjugate pneumococcal vaccine in human immunoedeficient virus infected and non-infected children in the absence of a booster dose of vaccine. Vaccine 2007; 25: 2451-2457
    • (2007) Vaccine , vol.25 , pp. 2451-2457
    • Madhi, S.A.1    Adrian, P.2    Kuwanda, L.3
  • 11
    • 27744442567 scopus 로고    scopus 로고
    • Immunogenicity and effectiveness of Haemophilus influenzae type b conjugate vaccine in HIV infected and uninfected African children
    • S.A. Madhi, L. Kuwanda, L. Saarinen, etal. Immunogenicity and effectiveness of Haemophilus influenzae type b conjugate vaccine in HIV infected and uninfected African children. Vaccine 2005; 23: 5517-5525
    • (2005) Vaccine , vol.23 , pp. 5517-5525
    • Madhi, S.A.1    Kuwanda, L.2    Saarinen, L.3
  • 12
    • 0036223722 scopus 로고    scopus 로고
    • Reduced effectiveness of Haemophilus influenzae type b conjugate vaccine in children with a high prevalence of human immunodeficiency virus type 1 infection
    • S.A. Madhi, K. Petersen, M. Khoosal, etal. Reduced effectiveness of Haemophilus influenzae type b conjugate vaccine in children with a high prevalence of human immunodeficiency virus type 1 infection. PIDJ 2002; 21: 315-321
    • (2002) PIDJ , vol.21 , pp. 315-321
    • Madhi, S.A.1    Petersen, K.2    Khoosal, M.3
  • 13
    • 77649242444 scopus 로고    scopus 로고
    • Hepatitis B vaccination and risk of hepatitis B infection in HIV-infected individuals
    • M.L. Landrum, K.H. Hullsiek, A. Ganesan, etal. Hepatitis B vaccination and risk of hepatitis B infection in HIV-infected individuals. AIDS 2010; 24: 545-555.
    • (2010) AIDS , vol.24 , pp. 545-555
    • Landrum, M.L.1    Hullsiek, K.H.2    Ganesan, A.3
  • 14
    • 84880764836 scopus 로고    scopus 로고
    • World Medical Assocation. Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Oct 28, Available at:, [Accessed 14 Feb 2013].
    • World Medical Assocation. Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Oct 28, 2008. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html.pdf?print- media-type&footer-right=[page]/[toPage] [Accessed 14 Feb 2013].
    • (2008)
  • 15
    • 84880812681 scopus 로고    scopus 로고
    • CIOMS. International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland, CIOMS.
    • CIOMS. 2002 International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland, CIOMS.
    • (2002)
  • 16
    • 57049189228 scopus 로고    scopus 로고
    • Natural history of human papillomavirus infections, cytologic and histologic abnormalities, and cancer
    • C.M. Wheeler. Natural history of human papillomavirus infections, cytologic and histologic abnormalities, and cancer. Obstet Gynecol Clin North Am 2008; 35: 519-536.
    • (2008) Obstet Gynecol Clin North Am , vol.35 , pp. 519-536
    • Wheeler, C.M.1
  • 18
    • 4944232942 scopus 로고    scopus 로고
    • Risk of high-grade squamous intraepithelial lesion in HIV-infected adolescents
    • A.B. Moscicki, J.H. Ellenberg, P. Crowley-Nowick etal. Risk of high-grade squamous intraepithelial lesion in HIV-infected adolescents. JID 2004; 190: 1413-1421.
    • (2004) JID , vol.190 , pp. 1413-1421
    • Moscicki, A.B.1    Ellenberg, J.H.2    Crowley-Nowick, P.3
  • 19
    • 33947595236 scopus 로고    scopus 로고
    • Quadrivalent Human Papillomavirus vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP)
    • RR-2, March 23:
    • L.E. Markowitz, E.F. Dunne, M. Saraiya M, etal. Quadrivalent Human Papillomavirus vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007; March 23: 56(RR-2): 1-24.
    • (2007) MMWR , vol.56 , pp. 1-24
    • Markowitz, L.E.1    Dunne, E.F.2    Saraiya, M.M.3
  • 20
    • 34248326338 scopus 로고    scopus 로고
    • The Future II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
    • The Future II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. NEJM 2007; 356: 1915-1927.
    • (2007) NEJM , vol.356 , pp. 1915-1927
  • 21
    • 79952471906 scopus 로고    scopus 로고
    • Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines
    • B. Romanowski. Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines. Hum Vaccin 2011; 7: 161-169.
    • (2011) Hum Vaccin , vol.7 , pp. 161-169
    • Romanowski, B.1
  • 22
    • 47549116006 scopus 로고    scopus 로고
    • Correlates of vaccine-induced immunity
    • S.A. Plotkin. Correlates of vaccine-induced immunity. CID 2008; 47: 401-409.
    • (2008) CID , vol.47 , pp. 401-409
    • Plotkin, S.A.1
  • 23
    • 77957311616 scopus 로고    scopus 로고
    • Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old
    • M.J. Levin, A.B. Moscicki, L.Y. Song, etal. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. JAIDS 2010; 55: 197-204.
    • (2010) JAIDS , vol.55 , pp. 197-204
    • Levin, M.J.1    Moscicki, A.B.2    Song, L.Y.3
  • 24
    • 78651250137 scopus 로고    scopus 로고
    • Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review and meta-analysis
    • Jan 12
    • B. Lu, A. Kumar, X. Castellsague etal. Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review and meta-analysis. BMC Infect Dis 2011; Jan 12: 11-13
    • (2011) BMC Infect Dis , pp. 11-13
    • Lu, B.1    Kumar, A.2    Castellsague, X.3
  • 25
    • 66149161654 scopus 로고    scopus 로고
    • Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised double-blind trial
    • N. Munoz, R. Manalastas Jr, P. Pitisuttithum etal. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised double-blind trial. Lancet 2009; 373: 1949-1957
    • (2009) Lancet , vol.373 , pp. 1949-1957
    • Munoz, N.1    Manalastas Jr, R.2    Pitisuttithum, P.3
  • 26
    • 80053237426 scopus 로고    scopus 로고
    • Persistence of type-specific human papillomavirus infection and increased long-term risk of cervical cancer
    • H.C. Chen, M. Schiffman, C.Y. Lin etal. Persistence of type-specific human papillomavirus infection and increased long-term risk of cervical cancer. JNCI 2011; 103: 1387-1396.
    • (2011) JNCI , vol.103 , pp. 1387-1396
    • Chen, H.C.1    Schiffman, M.2    Lin, C.Y.3
  • 27
    • 33947595236 scopus 로고    scopus 로고
    • Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007
    • CDC. MMWR, (No. RR-2).
    • CDC. Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR 2007; 56 (No. RR-2).
    • (2007) , pp. 56
  • 28
    • 84880829620 scopus 로고    scopus 로고
    • op. cit. note 2
    • Lurie & Wolfe, op. cit. note 2, pp. 853-856
    • Lurie, W.1
  • 29
    • 2542431297 scopus 로고    scopus 로고
    • The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs?
    • D. Wendler, E.J. Emanuel & R.K. Lie. The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs? AJPH 2004; 94: 923-928.
    • (2004) AJPH , vol.94 , pp. 923-928
    • Wendler, D.1    Emanuel, E.J.2    Lie, R.K.3
  • 30
    • 84880838334 scopus 로고    scopus 로고
    • eds., op. cit. note 3.
    • Hawkins & Emanuel, eds., op. cit. note 3.
    • Hawkins, E.1
  • 31
    • 2342428820 scopus 로고    scopus 로고
    • The standard of care debate: the Declaration of Helsinki versus the international consensus opinion
    • R.K. Lie, E. Emanuel, C. Grady & D. Wendler. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics 2004; 30: 190-193
    • (2004) J Med Ethics , vol.30 , pp. 190-193
    • Lie, R.K.1    Emanuel, E.2    Grady, C.3    Wendler, D.4
  • 32
    • 18844380471 scopus 로고    scopus 로고
    • Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis
    • A.A. Hyder & L. Dawson. Defining standard of care in the developing world: the intersection of international research ethics and health systems analysis. Developing World Bioethics 2005; 5: 142-152
    • (2005) Developing World Bioethics , vol.5 , pp. 142-152
    • Hyder, A.A.1    Dawson, L.2
  • 33
    • 0034908132 scopus 로고    scopus 로고
    • Equipoise and international human-subjects research
    • A.J. London. Equipoise and international human-subjects research. Bioethics 2001; 15: 312-332.
    • (2001) Bioethics , vol.15 , pp. 312-332
    • London, A.J.1
  • 34
    • 84880820126 scopus 로고    scopus 로고
    • Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects, op. cit. note 10.
    • Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects, op. cit. note 10.
  • 35
    • 84880838549 scopus 로고    scopus 로고
    • CIOMS, note 11.
    • CIOMS, note 11.
  • 36
    • 84880768154 scopus 로고    scopus 로고
    • op. cit. note 25
    • Lie, Emanuel, Grady etal., op. cit. note 25, pp. 923-928.
    • Lie1    Emanuel2    Grady3
  • 37
    • 84880764858 scopus 로고    scopus 로고
    • CIOMS, op. cit. note 11.
    • CIOMS, op. cit. note 11.
  • 38
    • 0030888982 scopus 로고    scopus 로고
    • An ethical dilemma: availability of antiretroviral therapy after clinical trials with HIV-infected patients are ended
    • P.E. Cleaton-Jones. An ethical dilemma: availability of antiretroviral therapy after clinical trials with HIV-infected patients are ended. BMJ 1997; 314: 887-888.
    • (1997) BMJ , vol.314 , pp. 887-888
    • Cleaton-Jones, P.E.1
  • 39
    • 77957311616 scopus 로고    scopus 로고
    • op. cit. note 19
    • Levin, Moscicki, Song etal., op. cit. note 19, pp. 197-204.
    • Levin1    Moscicki2    Song3
  • 40
    • 84880828110 scopus 로고    scopus 로고
    • Response to protective vaccines. Conference on Retroviruses and Opportunistic Infections, Seattle
    • WA
    • A. Weinberg, L.Y. Song, T. Fenton etal. Response to protective vaccines. Conference on Retroviruses and Opportunistic Infections, Seattle, WA, 2012.
    • (2012)
    • Weinberg, A.1    Song, L.Y.2    Fenton, T.3
  • 41
    • 84880773755 scopus 로고    scopus 로고
    • Evaluation of the efficacy of fewer than three doses of a bivalent HPV 16/18 vaccine
    • Eurogin. Lisbon, Portugal
    • A.R. Kreimer, A.C. Rodriguez, A. Hildesheim, etal. Evaluation of the efficacy of fewer than three doses of a bivalent HPV 16/18 vaccine. Eurogin. Lisbon, Portugal, 2011.
    • (2011)
    • Kreimer, A.R.1    Rodriguez, A.C.2    Hildesheim, A.3
  • 42
    • 79953869912 scopus 로고    scopus 로고
    • Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: a cluster randomized noninferiority trial
    • K.M. Neuzil, do G. Canh, V.D. Thiem, etal. Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: a cluster randomized noninferiority trial. JAMA 2011; 305: 1424-1431.
    • (2011) JAMA , vol.305 , pp. 1424-1431
    • Neuzil, K.M.1    Canh, D.G.2    Thiem, V.D.3
  • 43
    • 84880836369 scopus 로고    scopus 로고
    • op. cit. note 9
    • Madhi, Petersen, Khoosal, etal., op. cit. note 9, pp. 315-321
    • Madhi1    Petersen2    Khoosal3
  • 44
    • 84880801809 scopus 로고    scopus 로고
    • op. cit. note 9, pp. 545-555
    • Landrum, Hullsiek, Ganesan etal., op. cit. note 9, pp. 545-555; Advisory Committee on Immunization Practices. Updated recommendations for use of meningococcal conjugate vaccines. MMWR. 2011; 60: 72-76.
    • Landrum1    Hullsiek2    Ganesan3
  • 45
    • 79251607440 scopus 로고    scopus 로고
    • Updated recommendations for use of meningococcal conjugate vaccines
    • Advisory Committee on Immunization Practices
    • Advisory Committee on Immunization Practices. Updated recommendations for use of meningococcal conjugate vaccines. MMWR. 2011; 60: 72-76.
    • (2011) MMWR , vol.60 , pp. 72-76
  • 46
    • 84880799056 scopus 로고    scopus 로고
    • op. cit. note 34
    • Neuzil, Canh, Thiem etal., op. cit. note 34, pp. 1424-1431.
    • Neuzil1    Canh2    Thiem3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.