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clinical trial

Glucose-6-phosphate dehydrogenase activity in individuals with and without malaria: Analysis of clinical trial, cross-sectional and case-control data from Bangladesh

April 28, 2021 - 14:19 -- Open Access
Ley B, Alam MS, Price RN, et al.
PLoS Med. 2021 Apr 23;18(4):e1003576

Glucose-6-phosphate dehydrogenase (G6PD) activity is dependent upon G6PD genotype and age of the red blood cell (RBC) population, with younger RBCs having higher activity. Peripheral parasitemia with Plasmodium spp. induces hemolysis, replacing older RBCs with younger cells with higher G6PD activity. This study aimed to assess whether G6PD activity varies between individuals with and without malaria or a history of malaria.

Analytical validation of a real-time hydrolysis probe PCR assay for quantifying Plasmodium falciparum parasites in experimentally infected human adults

April 14, 2021 - 07:58 -- Open Access
Claire Y. T. Wang, Emma L. Ballard, Zuleima Pava, Louise Marquart, Jane Gaydon, Sean C. Murphy, David Whiley, Peter O’Rourke and James S. McCarthy
Malaria Journal 2021 20:181, 10 April 2021

Volunteer infection studies have become a standard model for evaluating drug efficacy against Plasmodium infections. Molecular techniques such as qPCR are used in these studies due to their ability to provide robust and accurate estimates of parasitaemia at increased sensitivity compared to microscopy. The validity and reliability of assays need to be ensured when used to evaluate the efficacy of candidate drugs in clinical trials.

Predicting the public health impact of a malaria transmission-blocking vaccine

March 10, 2021 - 13:16 -- Open Access
Challenger JD, Olivera Mesa D, Da DF, Yerbanga RS, Lefèvre T, Cohuet A, Churcher TS
Nat Commun. 2021 Mar 8;12(1):1494

Transmission-blocking vaccines that interrupt malaria transmission from humans to mosquitoes are being tested in early clinical trials. The activity of such a vaccine is commonly evaluated using membrane-feeding assays. Understanding the field efficacy of such a vaccine requires knowledge of how heavily infected wild, naturally blood-fed mosquitoes are, as this indicates how difficult it will be to block transmission.

A Systematic Literature Review of Microscopy Methods Reported in Malaria Clinical Trials

December 23, 2020 - 08:50 -- Open Access
Das D, Dahal P, Dhorda M, Citarella BW, Kennon K, Stepniewska K, Felger I, Chappuis F, Guerin PJ
Am J Trop Med Hyg. 2020 Dec 21

Microscopy of stained blood films is essential for the diagnosis of malaria, differentiation of parasite species, and estimation of parasite density performed for assessments of antimalarial drug efficacy. The accuracy and comparability of these measures over time and space are vital to discern the emergence or spread of antimalarial drug resistance. Although evidence-based guidelines for malaria microscopy methods exist, the age-old microscopy techniques for parasitological assessments are subject to considerable methodological variations.

Enhancing durability of CIS43 monoclonal antibody by Fc mutation or AAV delivery for malaria prevention

December 23, 2020 - 08:35 -- Open Access
Kielau Kisalu N, Da Silva Pereira L, Ernste KJ, Flores-Garcia Y, Idris AH, Asokan M, Dillon M, MacDonald S, Shi W, Chen X, Pegu A, Schön A, Zavala F, Balazs AB, Francica JR, Seder RA
JCI Insight. 2020 Dec 17:143958

CIS43 is a potent neutralizing human monoclonal antibody (mAb) that targets a highly conserved 'junctional' epitope in the Plasmodium falciparum (Pf) circumsporozoite protein (PfCSP). Enhancing the durability of CIS43 in vivo will be important for clinical translation. Here, two approaches were used to improve the durability of CIS43 in vivo while maintaining potent neutralization.

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
Chughlay MF, Rossignol E, Donini C, El Gaaloul M, Lorch U, Coates S, Langdon G, Hammond T, Möhrle J, Chalon S
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
Bayode R. Adegbite, Jean R. Edoa, Ayola A. Adegnika, et al.
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
Geneviève M. Labbé, Kazutoyo Miura, Simon J. Draper, et al.
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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