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Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine


, : Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine. Clinical Infectious Diseases 61 Suppl 5(): S422-S427

The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards. Because of the public-private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access. Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts. Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved. ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007).

US$19.90

PMID: 26553670

DOI: 10.1093/cid/civ598


Other references

Warr, J.R., 1987: Collateral sensitivity to verapamil in vincristine resistant cho cell lines. European Journal of Cancer and Clinical Oncology 23(11): 1811

Giannini, M.A.; Gaur, A.H.; Boudreaux, J.W.; Mestemacher, M.A.; Shenep, J.L.; Flynn, P.M.; Hayden, R.T., 2002: A prospective study of pediatric blood culture yields, comparing single volume to variable volume cultures in immunocompromised children. The optimal use of blood cultures to determine the etiology of febrile episodes in neutropenic children has not been well defined. We compared the yield of single volume blood cultures, using the Pediatric IsolatorTM System, with variable, weight-...

Yoshida, Akira, 1993: Preparation of single cell suspensions from paraffin-embedded tissue for FISH and its clinical application for gastric cancer cells. In the application of paraffin-embedded sections for fluorescence in situ hybridation (FISH), the effects of cell dispersion were compared among the three methods, Schutte Hedley and heiden methods, respectively. The cell shapes were best preserve...

Watanabe, S.; Kono, K.; Fujii, H.; Nakai, K.; Goto, S.; Nishi, S., 2016: Two Cases of Hypophosphatemia with Increased Renal Phosphate Excretion in Legionella Pneumonia. We encountered 2 cases of hypophosphatemia due to Legionella pneumonia. Both cases showed increased urinary phosphate excretion and renal tubular dysfunction, which ameliorated with recovery from Legionella pneumonia. Serum fibroblast growth facto...

Fairweather, D.; Frisancho Kiss, S.; Yusung, S.A., 2005: IL-12 Protects against Coxsackievirus B3-Induced Myocarditis by Increasing IFN-g and Macrophage and Neutrophil Populations in the Heart. Journal of Immunology 174(1): 1-9

White, J.M.L.; Higgins, E.M., 2004: Case 1. Diffuse melanonychia. Clinical and Experimental Dermatology 29(3): 331-332

Plath, P., 1979: Temporary total deafness in disseminated encephalomyelitis. Total deafness, which recovered, in an 18 year old woman with disseminated encephalomyelitis is reported. The deafness involved the left ear, but vestibular abnormalities were demonstrated bilaterally. After some weeks both auditory and vestibular...

Veimarn, AB.; Abramova, AN.; Artyushkova, OV.; Baryshev, VN.; Degtyarev, KE.; Kononova, LI.; Maslov, VA.; Moseichuk, VM.; Pazukhin, VN.; Puchkov, VN.; Tevelev, AV.; Shmelev, IV.; Yarkova, AV., 2002: Correlation of Famennian sections in South Urals. Byulleten' Moskovskogo Obshchestva Ispytatelei Prirody Otdel Geologicheskii. Yanvar'-Fevral'; 771: 32-42

Galoux, A., 1966: Rhythms of energy and phenological phases in Oak forests on calcareous soils. According to observations made in 1961 in the forest of Virelles-Blaimont, Belgium, the year can be divided into different phenological periods which are classified and described from the point of view of environmental changes and the growth cycle...

Bernston, G.M., 1995: The characterization of topology: A comparison of four topological indices for rooted binary trees. The quantification of the topological features of binary trees has been applied in several branches of biology, from botany to neurobiology to animal behaviour. The methods available for quantifying tree topology differ, both in how they are appli...