Author:
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Reference Manager
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-
1.
Duclos P, Okwo-Bele JM, Gacic-Dabo M, Cherian T, 2009. Global immunization: status, progress, challenges and future. BMC Int Health Hum Rights 9 (Suppl 1): S2.
-
2.
Birn AE, 2011. Small(pox) success? Cien Saude Colet 16: 591–597.
-
3.
Craddock S, 2012. Drug partnerships and global practices. Health Place 18: 481–489.
-
4.
Rehnquist J, 2001.The Globalization of Clinical Trials, a Growing Challenge in Protecting Human Subjects. Available at: http://oig.hhs.gov/oei. Accessed June 25, 2012.
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5.
Beurret M, Hamidi A, Kreeftenberg H, 2012. Development and technology transfer of Haemophilus influenzae type b conjugate vaccines for developing countries. Vaccine 30: 4897–4906.
-
6.
Louisa M, Takeuchi M, Steiabudy R, Nafrialdi, Takeuchi M, 2012. Current status of phase I clinical trials in Asia: an academic perspectives. Acta Med Indones 44: 71–77.
-
7.
Cutts FT, Zaman SMA, Enwere G, Jaffar S, Levine OS, Okoko BJ, Oluwalana C, Vaughan A, Obaro SK, Leach A, McAdam KP, Biney E, Saaka M, Onwuchekwa U, Yallop F, Pierce NF, Greenwood BM, Adegbola RA, 2005. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet 365: 1139–1146.
-
8.
Kremer M, 2001. Creating markets for new vaccines, Part I: Rationale. Jaffe AB, Lerner J, Stern S, eds. Innovation Policy and the Economy. Volume 1. Cambridge, MA: MIT Press, 35–72.
-
9.
Shapiro HT, Meslin EM, 2001. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med 345: 138–141.
-
10.
1998. Ethical issues facing medical research in developing countries. Gambia Government/Medical Research Council Joint Ethical Committee. Lancet 351: 286–287.
-
11.
UNICEF/WHO, 2011. Immunization Summary. Available at: http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/ED/GMR. Accessed August 3, 2012.
-
12.
Arenas-Lopez S, Fajardo C, Valls SA, Gracias-Corzo JR, Lima-Rogel MV, Calle G, Leite R, Lobos E, Hume-Wright Q, MacLeod S, 2011. Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future. Paediatr Drugs 13: 257–265.
-
13.
Steketee RW, Campbell CC, 2010. Impact of national malaria control scale-up programmes in Africa: magnitude and attribution of effects. Malar J 9: 299.
-
14.
Preziosi MP, Yam A, Ndiaye M, Simagu A, Simondon F, 1997. Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med 336: 370–373.
-
16.
Lang T, 2011. Adaptive trial design: could we use this approach to improve clinical trials in the field of global health? Am J Trop Med Hyg 85: 967–970.
-
17.
Fairhead J, Leach M, Small M, 2006. Public engagement with science? Local understandings of a vaccine trial in the Gambia. J Biosoc Sci 38: 103–116.
-
18.
UNESCO, 2010. Education for All Global Monitoring Report. Reaching the Marginalized. Available at: http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/ED/GMR. Accessed October 17, 2012.
-
19.
Erulkar AS, Muthengi E, 2009. Evaluation of Berhane Hewan: a program to delay child marriage in rural Ethiopia. Int Perspect Sex Reprod Health 35: 6–14.
-
20.
Ota MO, Idoko OT, Ogundare EO, Afolabi MO, 2012. Human immune responses to vaccines in the first year of life: biological, socio-economic and ethical issues: a viewpoint. Vaccine 2012 Jun 19 [Epub ahead of print].
-
21.
Nunez-Wallace KR, Gill CE, Harrison CH, Taylor HM, Charles PD, 2010. Discordance in informed consent response on the basis of demographic factors: brief report. Intellect Dev Disabil 48: 175–179.
-
22.
Sow SO, Okoko BJ, Diallo A, Viviani S, Carlone G, Tapia M, Borrow R, Akinsola AK, Arduin P, Findlow H, Elie C, Haidara FC, Parulekar V, Chaumont J, Martellet L, Diallo F, Idoko OT, Tang Y, Plikaytis BD, Kulkarni PS, Marchetti E, Laforce FM, Preziosi MP, 2011. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. N Engl J Med 364: 2293–2304.
-
23.
Howie SR, 2011. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ 89: 46–53.
-
24.
Kaufmann JR, Feldbaum H, 2009. Diplomacy and the polio immunization boycott in northern Nigeria. Health Aff (Millwood) 28: 1091–1101.
-
25.
Englev E, Petersen KP, 2003. ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives [in Danish]. Ugeskr Laeger 165: 1659–1662.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 35 | 35 | 10 |
| Full Text Views | 529 | 246 | 0 |
| PDF Downloads | 116 | 28 | 0 |
Impact, Challenges, and Future Projections of Vaccine Trials in Africa
Olubukola T. Idoko
Olubukola T. Idoko
Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia; PATH, New Delhi, India; Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Kenya Medical Research Institute, Kisumu, Kenya
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Sonali Kochhar
Sonali Kochhar
Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia; PATH, New Delhi, India; Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Kenya Medical Research Institute, Kisumu, Kenya
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Tsiri E. Agbenyega
Tsiri E. Agbenyega
Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia; PATH, New Delhi, India; Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Kenya Medical Research Institute, Kisumu, Kenya
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Bernhards Ogutu
Bernhards Ogutu
Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia; PATH, New Delhi, India; Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Kenya Medical Research Institute, Kisumu, Kenya
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Martin O. C. Ota
Martin O. C. Ota
Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia; PATH, New Delhi, India; Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Kenya Medical Research Institute, Kisumu, Kenya
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Immunization remains the most cost effective method for the control of infectious diseases. Therefore, there is a global effort to deploy new vaccines for disease control and eradication. These new vaccines must be tested in the settings in which they will be used. This necessity has required the conduct of many vaccine trials in Africa, where several infectious diseases with significant public health impact are prevalent. However, these areas have peculiarities and are just beginning to gain expertise in the conduct of such trials. The vaccine developers and sponsors of these trials may also not be conversant with some issues unique to the trial site. The understanding gap from both partners can result in challenges if not addressed during the planning phase of the trial. This review seeks to highlight the issues surrounding the conduct of clinical trials in resource-constrained settings and suggests some ways of circumventing them.
Author Notes
Authors' addresses: Olubukola T. Idoko, Department of Vaccinology, Medical Research Council Unit, Fajara, The Gambia, E-mail: oidoko@mrc.gm. Sonali Kochhar, Clinical Research and Drug Development, PATH, New Delhi, India, E-mail: skochhar@path.com. Tsiri E. Agbenyega, Department of Physiology, Kwame Nkurma University of Science and Technology, Kumasi, Ghana, E-mail: tsiri@ghana.com. Bernhards Ogutu, Department of Clinical Trials, Kenya Medical Research Institute, Kisumu, Kenya, E-mail: ogutu6@gmail.com. Martin O. C. Ota, Department of Vaccinology, Medical Research Council Unit, Fajara, The Gambia, E-mail: mota@mrc.gm.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Duclos P, Okwo-Bele JM, Gacic-Dabo M, Cherian T, 2009. Global immunization: status, progress, challenges and future. BMC Int Health Hum Rights 9 (Suppl 1): S2.
-
2.
Birn AE, 2011. Small(pox) success? Cien Saude Colet 16: 591–597.
-
3.
Craddock S, 2012. Drug partnerships and global practices. Health Place 18: 481–489.
-
4.
Rehnquist J, 2001.The Globalization of Clinical Trials, a Growing Challenge in Protecting Human Subjects. Available at: http://oig.hhs.gov/oei. Accessed June 25, 2012.
-
5.
Beurret M, Hamidi A, Kreeftenberg H, 2012. Development and technology transfer of Haemophilus influenzae type b conjugate vaccines for developing countries. Vaccine 30: 4897–4906.
-
6.
Louisa M, Takeuchi M, Steiabudy R, Nafrialdi, Takeuchi M, 2012. Current status of phase I clinical trials in Asia: an academic perspectives. Acta Med Indones 44: 71–77.
-
7.
Cutts FT, Zaman SMA, Enwere G, Jaffar S, Levine OS, Okoko BJ, Oluwalana C, Vaughan A, Obaro SK, Leach A, McAdam KP, Biney E, Saaka M, Onwuchekwa U, Yallop F, Pierce NF, Greenwood BM, Adegbola RA, 2005. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet 365: 1139–1146.
-
8.
Kremer M, 2001. Creating markets for new vaccines, Part I: Rationale. Jaffe AB, Lerner J, Stern S, eds. Innovation Policy and the Economy. Volume 1. Cambridge, MA: MIT Press, 35–72.
-
9.
Shapiro HT, Meslin EM, 2001. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med 345: 138–141.
-
10.
1998. Ethical issues facing medical research in developing countries. Gambia Government/Medical Research Council Joint Ethical Committee. Lancet 351: 286–287.
-
11.
UNICEF/WHO, 2011. Immunization Summary. Available at: http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/ED/GMR. Accessed August 3, 2012.
-
12.
Arenas-Lopez S, Fajardo C, Valls SA, Gracias-Corzo JR, Lima-Rogel MV, Calle G, Leite R, Lobos E, Hume-Wright Q, MacLeod S, 2011. Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future. Paediatr Drugs 13: 257–265.
-
13.
Steketee RW, Campbell CC, 2010. Impact of national malaria control scale-up programmes in Africa: magnitude and attribution of effects. Malar J 9: 299.
-
14.
Preziosi MP, Yam A, Ndiaye M, Simagu A, Simondon F, 1997. Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med 336: 370–373.
-
16.
Lang T, 2011. Adaptive trial design: could we use this approach to improve clinical trials in the field of global health? Am J Trop Med Hyg 85: 967–970.
-
17.
Fairhead J, Leach M, Small M, 2006. Public engagement with science? Local understandings of a vaccine trial in the Gambia. J Biosoc Sci 38: 103–116.
-
18.
UNESCO, 2010. Education for All Global Monitoring Report. Reaching the Marginalized. Available at: http://www.unesco.org/new/fileadmin/MULTIMEDIA/HQ/ED/GMR. Accessed October 17, 2012.
-
19.
Erulkar AS, Muthengi E, 2009. Evaluation of Berhane Hewan: a program to delay child marriage in rural Ethiopia. Int Perspect Sex Reprod Health 35: 6–14.
-
20.
Ota MO, Idoko OT, Ogundare EO, Afolabi MO, 2012. Human immune responses to vaccines in the first year of life: biological, socio-economic and ethical issues: a viewpoint. Vaccine 2012 Jun 19 [Epub ahead of print].
-
21.
Nunez-Wallace KR, Gill CE, Harrison CH, Taylor HM, Charles PD, 2010. Discordance in informed consent response on the basis of demographic factors: brief report. Intellect Dev Disabil 48: 175–179.
-
22.
Sow SO, Okoko BJ, Diallo A, Viviani S, Carlone G, Tapia M, Borrow R, Akinsola AK, Arduin P, Findlow H, Elie C, Haidara FC, Parulekar V, Chaumont J, Martellet L, Diallo F, Idoko OT, Tang Y, Plikaytis BD, Kulkarni PS, Marchetti E, Laforce FM, Preziosi MP, 2011. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. N Engl J Med 364: 2293–2304.
-
23.
Howie SR, 2011. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ 89: 46–53.
-
24.
Kaufmann JR, Feldbaum H, 2009. Diplomacy and the polio immunization boycott in northern Nigeria. Health Aff (Millwood) 28: 1091–1101.
-
25.
Englev E, Petersen KP, 2003. ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives [in Danish]. Ugeskr Laeger 165: 1659–1662.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 35 | 35 | 10 |
| Full Text Views | 529 | 246 | 0 |
| PDF Downloads | 116 | 28 | 0 |