1921
Volume 90, Issue 5
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and malaria are among the most important infectious diseases in developing countries. Existing control strategies are unlikely to curtail these diseases in the absence of efficacious vaccines. Testing of HIV and malaria vaccines candidates start with early phase trials that are increasingly being conducted in developing countries where the burden of the diseases is high. Unique challenges, which affect planning and implementation of vaccine trials according to internationally accepted standards have thus been identified. In this review, we highlight specific challenges encountered during two early phase trials of novel HIV-1 and malaria vectored vaccine candidates conducted in The Gambia and how some of these issues were pragmatically addressed. We hope our experience will be useful for key study personnel involved in day-to-day running of similar clinical trials. It may also guide future design and implementation of vaccine trials in resource-constrained settings.

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2014-05-07
2017-09-20
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References

  1. Hay S, Okiro E, Gething P, Patil A, Tatem A, Guerra C, Snow RW, , 2010. Estimating the global clinical burden of Plasmodium falciparum Malaria in 2007. PLoS Med 7: e1000290.[Crossref]
  2. WHO, 2012. Global Health Observatory-HIV/AIDS. Available at: http://www.who.int/gho/hiv/en/. Accessed July 22, 2013.
  3. Kilama WL, Wanga CL, , 2007. Towards an African-driven malaria vaccine development program: history and activities of the African Malaria Network Trust (AMANET). Am J Trop Med Hyg 77: 282288.
  4. Mugyenyi PN, , 2002. HIV vaccines: the Uganda experience. Vaccine 20: 19051908.[Crossref]
  5. Chilengi R, , 2009. Clinical development of malaria vaccines: should earlier trials be done in malaria endemic countries? Hum Vaccin 5: 627636.[Crossref]
  6. Mwangoka G, Ogutu B, Msambichaka B, Mzee T, Salim N, Kafuruki S, Mpina M, Shekalaghe S, Tanner M, Abdulla S, , 2013. Experience and challenges from clinical trials with malaria vaccines in Africa. Malar J 12: 86.[Crossref]
  7. Girad M, Reed Z, Friede M, Kieny M, , 2007. A review of human vaccine research and development: malaria. Vaccine 25: 15671580.[Crossref]
  8. Moorthy V, Reed Z, Smith P, , 2007. Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation. Vaccine 25: 51155123.[Crossref]
  9. Sullivan M, , 2009. Moving candidate vaccines into development from research: lessons from HIV. Immunol Cell Biol 87: 366370.[Crossref]
  10. Ibanga HB, Brookes RH, Hill PC, Owiafe PK, Fletcher HA, Lienhardt C, Hill AV, Adegbola RA, McShane H, , 2006. Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. Lancet Infect Dis 6: 522528.[Crossref]
  11. Idoko OT, Kochhar S, Agbenyega TE, Ogutu B, Ota MO, , 2013. Impact, challenges, and future projections of vaccine trials in Africa. Am J Trop Med Hyg 88: 414419.[Crossref]
  12. Jaffar S, Amuron B, Birungi J, Namara G, Nabiryo C, Coutinho A, Grosskurth H, , 2008. Integrating research into routine service delivery in an antiretroviral treatment programme: lessons learnt from a cluster randomized trial comparing strategies of HIV care in Jinja, Uganda. Trop Med Int Health 13: 795800.[Crossref]
  13. Saidu Y, Odutola A, Jafali J, Ogundare O, Worwui A, Sey G, Thomas V, Stanley-Batchilly E, Afolabi M, Idoko OT, Owolabi O, Ota MO, , 2013. Contextualizing the informed consent process in vaccine trials in developing countries. J Clinic Res Bioeth 4: 141.
  14. Bekker LG, Jaspan H, McIntyre J, Wood R, Gray G, , 2005. Adolescents and HIV vaccine trials: what are the clinical trial site issues? J Int Assoc Physicians AIDS Care (Chic) 4: 9397.[Crossref]
  15. Fawzi WW, Msamanga GI, Spiegelman D, Urassa EJ, Hunter DJ, , 1999. Rationale and design of the Tanzania Vitamin and HIV Infection Trial. Control Clin Trials 20: 7590.[Crossref]
  16. Lang TA, White NJ, Tran HT, Farrar JJ, Day NP, Fitzpatrick R, Angus BJ, Denis E, Merson L, Cheah PY, Chilengi R, Kimutai R, Marsh K, , 2010. Clinical research in resource-limited settings: enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis 4: e619.[Crossref]
  17. Grady C, Levine RJ, Lavery JV, Grady C, Wahl ER, Emanuel EJ, , 2007. Commentary 13.2: shared responsibilities for treatment in the South African phase I HIV vaccine preventative trials. In (Eds.), Ethical Issues in International Biomedical Research: A Casebook. New York: Oxford University Press, Inc., pp. 225232.
  18. Nyika A, Chilengi R, Ishengoma D, Mtenga S, Thera MA, Sissoko MS, Lusingu J, Tiono AB, Doumbo O, Sirima SB, Lemnge M, Kilama WL, , 2010. Engaging diverse communities participating in clinical trials: case examples from across Africa. Malar J 9: 86.[Crossref]
  19. Sista ND, Abdool Karim Q, Hinson K, Donnell D, Eshleman SH, Vermund SH, , 2011. Experience in international clinical research: the HIV Prevention Trials Network. Clin Investig (Lond) 1: 16091618.[Crossref]
  20. Leach M, Fairhead J, , 2011. Being ‘with Medical Research Council’: infant care and the social meanings of cohort membership in Gambia's plural therapeutic landscapes. In: Evidence, ethos and experiment: the anthropology and history of medical research in Africa. Berghahn Series. New York: Berghahn Books, New York: Oxford, pp. 7798.
  21. Essack Z, Koen J, Barsdorf N, Slack C, Quayle M, Milford C, Lindegger G, Ranchod C, Mukuka R, , 2010. Stakeholder perspectives on ethical challenges in HIV vaccine trials in South Africa. Dev World Bioeth 10: 1121.[Crossref]
  22. Moodley K, , 2002. HIV Vaccine Trial participation in South Africa: an ethical assessment. J Med Philos 27: 197215.[Crossref]
  23. Ota MO, Idoko OT, Ogundare EO, Afolabi MO, , 2013. Human immune responses to vaccines in the first year of life: biological, socio-economic and ethical issues ; a viewpoint. Vaccine 31: 24832488.[Crossref]
  24. Chapman R, Chege G, Shephard E, Stutz H, Williamson AL, , 2010. Recombinant Mycobacterium bovis BCG as an HIV vaccine vector. Curr HIV Res 8: 282298.[Crossref]
  25. Sepulveda RL, Arredondo S, Rodriguez E, Gonzalez B, Leiva LE, Sorensen RU, , 1997. Effect of human newborn BCG immunization on monocyte viability and function at 3 months of age. Int J Tuberc Lung Dis 1: 122127.
  26. White GP, Watt PM, Holt BJ, Holt PG, , 2002. Differential patterns of methylation of the IFN-gamma promoter at CpG and non-CpG sites underlie differences in IFN-gamma gene expression between human neonatal and adult CD45RO-T cells. J Immunol 168: 28202827.[Crossref]
  27. Kampmann B, Tena-Coki G, Anderson S, , 2006. Blood tests for diagnosis of tuberculosis. Lancet 368: 282, author reply 282–283.[Crossref]
  28. Matsuo K, Yasutomi Y, , 2011. Mycobacterium bovis Bacille Calmette-Guerin as a vaccine vector for global infectious disease control. Tuberc Res Treat 2011: 574591.
  29. Kumar P, , 2013. Challenges on induction of broadly neutralizing antibodies for optimization of HIV vaccines development and vectored immunoprophylaxis. J Immune Based Ther Vaccines 2: 913.[Crossref]
  30. Kwong PD, Mascola JR, Nabel GJ, , 2011. Rational design of vaccines to elicit broadly neutralizing antibodies to HIV-1. Cold Spring Harb Perspect Med 1: a007278. doi:10.1101/cshperspect.a00727.[Crossref]
  31. Schim van der Loeff MF, Sarge-Njie R, Ceesay S, Awasana AA, Jaye P, Sam O, Jaiteh KO, Cubitt D, Milligan P, Whittle HC, , 2003. Regional differences in HIV trends in The Gambia: results from sentinel surveillance among pregnant women. AIDS 17: 18411846.[Crossref]
  32. Otti PO, Jallow C, , 2003. A Socio-Cultural Study of HIV/AIDS in The Gambia. UNDP/UN System and Government of The Gambia. Available at: http://ergodd.zoo.ox.ac.uk/download/reports/Socio-culturalStudyERGORevisedFinal.pdf. Accessed October 18, 2013.
  33. WHO, 2010. Delivering HIV test results and messages for re-testing and counseling in adults. Available at: http://www.who.int/hiv/pub/vct/hiv_re_testing/en/index.html. Accessed August 4, 2013.
  34. Goonetilleke N, Moore S, Dally L, Winstone N, Cebere I, Mahmoud A, Pinheiro S, Gillespie G, Brown D, Loach V, Roberts J, Guimaraes-Walker A, Hayes P, Loughran K, Smith C, De Bont J, Verlinde C, Vooijs D, Schmidt C, Boaz M, Gilmour J, Fast P, Dorrell L, Hanke T, McMichael AJ, , 2006. Induction of multifunctional human immunodeficiency virus type 1 (HIV-1)-specific T cells capable of proliferation in healthy subjects by using a prime-boost regimen of DNA- and modified vaccinia virus Ankara-vectored vaccines expressing HIV-1 Gag coupled to CD8+ T-cell epitopes. J Virol 80: 47174728.[Crossref]
  35. WHO, 2010. WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children. WHO Library Cataloguing-in-Publication Data. Available at: http://whqlibdoc.who.int/publications/2010/9789241599085_eng.pdf. Accessed December 7, 2013.
  36. Quinto L, Aponte JJ, Sacarlal J, Espasa M, Aide P, Mandomando I, Guinovart C, Macete E, Navia MM, Thompson R, Menendez C, Alonso PL, , 2006. Hematological and biochemical indices in young African children: in search of reference intervals. Trop Med Int Health 11: 17411748.[Crossref]
  37. Kumwenda NI, Khonje T, Mipando L, Nkanaunena K, Katundu P, Lubega I, Elbireer A, Bolton S, Bagenda D, Mubiru M, Fowler MG, Taha TE, , 2012. Distribution of hematological and chemical pathology values among infants in Malawi and Uganda. Paediatr Int Child Health 32: 213227.[Crossref]
  38. Dhingra B, Mishra D, , 2011. Immediate versus as-needed acetaminophen for post-immunization pyrexia. Ann Trop Paediatr 31: 339344.[Crossref]
  39. Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC, , 2011. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS ONE 6: e20102.[Crossref]
  40. Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S, , 2013. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b vaccine. BMC Pediatr 13: 98.[Crossref]
  41. Shields B, Wacogne I, Wright CM, , 2012. Weight faltering and failure to thrive in infancy and early childhood. BMJ 345: e5931.[Crossref]
  42. Bejon PM, Kai O, , 2007. The induction and persistence of T cell IFN-gamma responses after vaccination or natural exposure is suppressed by Plasmodium falciparum . J Immunol 179: 41934201.[Crossref]
  43. Ceesay SJ, Casals-Pascual C, Erskine J, Anya SE, Duah NO, Fulford AJC, Sesay SSS, Abubakar I, Dunyo S, Sey O, Palmer A, Fofana M, Corrah T, Bojang KA, Whittle HC, Greenwood BM, Conway DJ, , 2008. Changes in malaria indices between 1999 and 2007 in The Gambia: a retrospective analysis. Lancet 372: 15451554.[Crossref]
  44. Ceesay SJ, Casals-Pascual C, Nwakanma DC, Walther M, Gomez-Escobar N, Fulford AJ, Takem EN, Nogaro S, Bojang KA, Corrah T, Jaye MC, Taal MA, Sonko AA, Conway DJ, , 2010. Continued decline of malaria in The Gambia with implications for elimination. PLoS ONE 5: e12242.[Crossref]
  45. Ghouth AS, Nasseb FM, Al-Kaldy KH, , 2012. The accuracy of the first response histidine-rich protein2 rapid diagnostic test compared with malaria microscopy for guiding field treatment in an outbreak of falciparum malaria. Tropenmed Parasitol 2: 3537.[Crossref]
  46. Abba K, Deeks JJ, Olliaro P, Naing CM, Jackson SM, Takwoingi Y, Donegan S, Garner P, , 2011. Rapid diagnostic tests for diagnosing uncomplicated P. falciparum malaria in endemic countries. Cochrane Database Syst Rev CD008122.
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  • Received : 24 Oct 2013
  • Accepted : 06 Jan 2014

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