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trial

Open Access | Case study: Sustainable development of a GCP-compliant clinical trials platform in Africa: the Malaria Clinical Trials Alliance perspective

April 21, 2010 - 09:55 -- Kabogo Ndegwa
Author(s): 
Ogutu BR, Baiden R, Diallo D, Smith PG, Binka FN
Reference: 
Malaria Journal 2010, 9:103 (20 April 2010)

In three years, MCTA strengthened 13 centres or sites to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial.

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Open Access | Research: Randomized controlled trial of artesunate or artemether in Vietnamese adults with severe falciparum malaria

April 16, 2010 - 08:29 -- Kabogo Ndegwa
Author(s): 
Phu NH, Tuan PQ, Day N, Mai NT, Chau TT, Chuong LV, Sinh DX, White NJ, Farrar J, Tran HT
Reference: 
Malaria Journal 2010, 9:97 (15 April 2010)

Both artemether and artesunate have been shown to be superior to quinine for the treatment of severe falciparum malaria in Southeast Asian adults, although the magnitude of the superiority has been greater for artesunate than artemether. These two artemisinin derivatives had not been compared in a randomized trial.

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Open Access | Research: How can malaria rapid diagnostic tests achieve their potential? A qualitative study of a trial at health facilities in Ghana

April 16, 2010 - 08:03 -- Kabogo Ndegwa
Author(s): 
Chandler CI, Whitty CJ, Ansah EK
Reference: 
Malaria Journal 2010, 9:95 (14 April 2010)

Rapid diagnostic tests (RDTs) for malaria are at the early stages of introduction across malaria endemic countries. This is central to efforts to decrease malaria overdiagnosis and the consequent overuse of valuable anti-malarials and underdiagnosis of alternative causes of fever.

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Open Access | Intermittent preventive treatment in infants for the prevention of malaria in rural Western Kenya: a randomized, double-blind placebo-controlled trial

April 8, 2010 - 07:00 -- Kabogo Ndegwa
Author(s): 
FO Odhiambo, MJ Hamel, J Williamson, K Lindblade, FO ter Kuile, E Peterson, P Otieno, S Kariuki, J Vulule, L Slutsker, RD Newman
Reference: 
PLoS One (2010) 5: e10016.

IPTi with long-acting regimens provide protection against clinical malaria for up to 8 weeks even in the presence of high ITN coverage, and that the prophylactic rather than the treatment effect of IPTi appears central to its protective efficacy.

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Phase 1 safety and immunogenicity trial of the Plasmodium falciparum blood-stage malaria vaccine AMA1-C1/ISA 720 in Australian adults

March 5, 2010 - 12:12 -- Kabogo Ndegwa
Author(s): 
Mark A. Pierce, Ruth D. Ellis, Louis H. Miller et al.
Reference: 
Vaccine, Volume 28, Issue 10, 2 March 2010, Pages 2236-2242

A Phase 1 trial was conducted in malaria-naïve adults to evaluate the recombinant protein vaccine apical membrane antigen 1-Combination 1 (AMA1-C1) formulated in Montanide® ISA 720 (SEPPIC, France), a water-in-oil adjuvant. 

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Multiple functions of human T cells generated by experimental malaria challenge

November 10, 2009 - 20:40 -- Ingeborg van Schayk
Author(s): 
Stephen M. Todryk, Michael Walther, Philip Bejon, Claire Hutchings, Fiona M. Thompson, Britta C. Urban, David W. Porter, Adrian V. S. Hill
Reference: 
European Journal of Immunology, Volume 39 Issue 11, Pages 3042 – 3051

In this study, cellular immune responses were investigated in individuals receiving Plasmodium falciparum sporozoite challenge by the natural (mosquito bite) route as part of a malaria vaccine efficacy trial. 

 

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The Synthetic Plasmodium falciparum Circumsporozoite Peptide PfCS102 as a Malaria Vaccine Candidate: A Randomized Controlled Phase I Trial

November 10, 2009 - 13:53 -- Ingeborg van Schayk
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Author(s): 
Audran R, Lurati-Ruiz F, Genton B, Blythman HE, Ofori-Anyinam O, et al.
Reference: 
PLoS ONE 4(10): e7304

PfCS102 peptide was safe and highly immunogenic, allowing the design of more advanced trials to test its potential for protection. Two or three immunizations with a dose of 30 µg formulated with AS02A appeared the most appropriate choice for such studies.

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Randomized Controlled Trial of RTS,S/AS02D and RTS,S/AS01E Malaria Candidate Vaccines Given According to Different Schedules in Ghanaian Children

November 10, 2009 - 13:46 -- Ingeborg van Schayk
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Author(s): 
Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, et al.
Reference: 
PLoS ONE 4(10): e7302

Both candidate malaria vaccines were well tolerated. Anti-circumsporozoite responses were greater with RTS,S/AS01E than RTS,S/AS02D and when 3 rather than 2 doses were given. This study supports the selection of RTS,S/AS01E and a 3 dose schedule for further development in children and infants.

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A Randomized Trial Assessing the Safety and Immunogenicity of AS01 and AS02 Adjuvanted RTS,S Malaria Vaccine Candidates in Children in Gabon

November 10, 2009 - 13:26 -- Ingeborg van Schayk
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Author(s): 
Lell B, Agnandji S, von Glasenapp I, Haertle S, Oyakhiromen S, et al.
Reference: 
PLoS ONE 4(10): e7611

RTS,S/AS01E proved similarly as well tolerated and immunogenic as RTS,S/AS02D, completing an essential step in the age de-escalation process within the RTS,S clinical development plan.

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