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clinical trial

NOT Open Access | First-in-human clinical trial to assess safety, tolerability and pharmacokinetics of P218, a novel candidate for malaria chemoprotection

January 14, 2020 - 09:44 -- NOT Open Access
Author(s): 
Chughlay MF, Rossignol E, Donini C, El Gaaloul M, Lorch U, Coates S, Langdon G, Hammond T, Möhrle J, Chalon S
Reference: 
Br J Clin Pharmacol. 2020 Jan 11

This first‐in‐human clinical trial of P218, a novel dihydrofolate reductase inhibitor antimalarial candidate, assessed safety, tolerability, pharmacokinetics and food effect in healthy subjects.

Monitoring of efficacy, tolerability and safety of artemether–lumefantrine and artesunate–amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial

December 17, 2019 - 16:46 -- Open Access
Author(s): 
Bayode R. Adegbite, Jean R. Edoa, Ayola A. Adegnika, et al.
Reference: 
Malaria Journal 2019 18:424, 16 December 2019

Malaria remains a major public health problem, affecting mainly low-and middle-income countries. The management of this parasitic disease is challenged by ever increasing drug resistance. This study, investigated the therapeutic efficacy, tolerability and safety of artemether–lumefantrine (AL) and artesunate–amodiaquine (AS–AQ), used as first-line drugs to treat uncomplicated malaria in Lambaréné, Gabon.

Job: BOHEMIA Clinical Trial Clinical Trial investigator, Mopeia Site (Mozambique)

November 21, 2019 - 16:19 -- MalariaWorld Jobs

Job title: Clinical Trial Investigator for Mopeia site (Mozambique)
Reports to: Mozambique BOHEMIA National Principal Investigator and the ISGlobal BOHEMIA Chief Scientific Officer

Harmonization study between three laboratories for expression of malaria vaccine clinical trial IgG antibody ELISA data in µg/mL

September 14, 2019 - 15:20 -- Open Access
Author(s): 
Geneviève M. Labbé, Kazutoyo Miura, Simon J. Draper, et al.
Reference: 
Malaria Journal 2019 18:300, 2 September 2019

The ability to report vaccine-induced IgG responses in terms of µg/mL, as opposed arbitrary units (AU), enables a more informed interpretation of the magnitude of the immune response, and better comparison between vaccines targeting different antigens. However, these interpretations rely on the accuracy of the methodology, which is used to generate ELISA data in µg/mL. In a previous clinical trial of a vaccine targeting the apical membrane antigen 1 (AMA1) from Plasmodium falciparum, three laboratories (Oxford, NIH and WRAIR) reported ELISA data in µg/mL that were correlated but not concordant. This current study sought to harmonize the methodology used to generate a conversion factor (CF) for ELISA analysis of human anti-AMA1 IgG responses across the three laboratories.

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