Browsing by Author "Choy RKM"

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Association of biomarkers of enteric dysfunction, systemic inflammation, and growth hormone resistance with seroconversion to oral rotavirus vaccine: A lasso for inference approach.
(2023) Mwila-Kazimbaya K; Bosomprah S; Chilyabanyama ON; Chisenga CC; Chibuye M; Laban NM; Simuyandi M; Huffer B; Iturriza-Gomara M; Choy RKM; Chilengi R; Department of Global Health, Amsterdam Institute for Global Health and Development (AIGHD), Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.; Department of Biostatistics, School of Public Health, University of Ghana, Accra, Ghana.; PATH, Seattle, Washington, United States of America.; Research Division, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, United States of America.; Centre for Vaccine Innovation and Access, PATH, Geneve, Switzerland.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: Rotavirus gastroenteritis remains a leading cause of morbidity and mortality despite the introduction of vaccines. Research shows there are several factors contributing to the reduced efficacy of rotavirus vaccines in low- and middle-income settings. Proposed factors include environmental enteric dysfunction (EED), malnutrition, and immune dysfunction. This study aimed to assess the effect of these factors on vaccine responses using a machine learning lasso approach. METHODS: Serum samples from two rotavirus clinical trials (CVIA 066 n = 99 and CVIA 061 n = 124) were assessed for 11 analytes using the novel Micronutrient and EED Assessment Tool (MEEDAT) multiplex ELISA. Immune responses to oral rotavirus vaccines (Rotarix, Rotavac, and Rotavac 5D) as well as a parenteral rotavirus vaccine (trivalent P2-VP8) were also measured and machine learning using the lasso approach was then applied to investigate any associations between immune responses and environmental enteric dysfunction, systemic inflammation, and growth hormone resistance biomarkers. RESULTS: Both oral and parenteral rotavirus vaccine responses were negatively associated with retinol binding protein 4 (RBP4), albeit only weakly for oral vaccines. The parenteral vaccine responses were positively associated with thyroglobulin (Tg) and histidine-rich protein 2 (HRP2) for all three serotypes (P8, P6 and P4), whilst intestinal fatty acid binding protein (I-FABP) was negatively associated with P6 and P4, but not P8, and soluble transferrin receptor (sTfR) was positively associated with P6 only. CONCLUSION: MEEDAT successfully measured biomarkers of growth, systemic inflammation, and EED in infants undergoing vaccination, with RBP4 being the only analyte associated with both oral and parenteral rotavirus vaccine responses. Tg and HRP2 were associated with responses to all three serotypes in the parenteral vaccine, while I-FABP and sTfR results indicated possible strain specific immune responses to parenteral immunization.
Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023.
(2024-Feb) Cavaleri M; Kaslow D; Boateng E; Chen WH; Chiu C; Choy RKM; Correa-Oliveira R; Durbin A; Egesa M; Gibani M; Kapulu M; Katindi M; Olotu A; Pongsuwan P; Simuyandi M; Speder B; Talaat KR; Weller C; Wills B; Baay M; Balasingam S; Olesen OF; Neels P; Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.; PATH Center for Vaccine Innovation and Access, Seattle, WA, USA. Electronic address: rchoy@path.org.; European Vaccine Initiative, Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.; Imperial College London, UK. Electronic address: c.chiu@imperial.ac.uk.; Centre for Infectious Disease Research, Zambia. Electronic address: Michelo.Simuyandi@cidrz.org.; Center for Vaccine Development, University of Maryland School of Medicine, USA. Electronic address: wilbur.chen@som.umaryland.edu.; IABS-EU, Lyon, France. Electronic address: pieter.neels@vaccine-advice.be.; Imperial College London, UK. Electronic address: m.gibani@imperial.ac.uk.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: ktalaat@jhu.edu.; KEMRI-Wellcome Trust Research Programme, Kenya. Electronic address: mkapulu@kemri-wellcome.org.; HVIVO plc, UK. Electronic address: b.speder@hvivo.com.; Wellcome Trust, London, UK. Electronic address: shobana.balasingam@wellcome.org.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: adurbin1@jhu.edu.; US Food & Drugs Administration, USA. Electronic address: david.kaslow@fda.hhs.gov.; P95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.; Food and Drugs Authority, Ghana. Electronic address: gus4tee@gmail.com.; European Medicines Agency, Netherlands. Electronic address: marco.cavaleri@ema.europa.eu.; Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam. Electronic address: bwills@oucru.org.; Wellcome Trust, London, UK. Electronic address: C.Weller@wellcome.org.; Ifakara Health Institute, Tanzania. Electronic address: aolotu@ihi.or.tz.; Fundação Oswaldo Cruz (Fiocruz), Brazil.; Katindi & Company, Kenya. Electronic address: mkatindi@katindilawyers.co.ke.; MRC/UVRI and LSHTM Uganda Research Unit, Uganda; London School of Hygiene and Tropical Medicine, UK. Electronic address: Moses.Egesa@mrcuganda.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.
The 2022 Vaccines Against Shigella and Enterotoxigenic Escherichia coli (VASE) Conference: Summary of abstract-based presentations.
(2024-Mar-07) Banerjee S; Barry EM; Baqar S; Louis Bourgeois A; Campo JJ; Choy RKM; Chakraborty S; Clifford A; Deal C; Estrada M; Fleckenstein J; Hasso-Agopsowicz M; Hausdorff W; Khalil I; Maier N; Mubanga C; Platts-Mills JA; Porter C; Qadri F; Simuyandi M; Walker R; White JA; Washington University School of Medicine, United States.; PATH, United States. Electronic address: aclifford@path.org.; Centre for Infectious Disease Research in Zambia, Zambia.; Antigen Discovery, Inc, United States.; PATH, United States; Faculty of Medicine, Université Libre de Bruxelles, Belgium.; ICMR - National Institute of Cholera and Enteric Diseases, India.; PATH, United States.; Naval Medical Research Command, United States.; World Health Organization, Switzerland.; University of Washington, United States.; US National Institutes of Health, United States.; Johns Hopkins University, United States.; Division of Infectious Diseases and International Health, University of Virginia, United States.; ICDDR,B, Bangladesh.; University of Maryland School of Medicine, United States.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
The global nonprofit organization PATH hosted the third Vaccines Against Shigella and Enterotoxigenic Escherichia coli (VASE) Conference in Washington, DC, on November 29 to December 1, 2022. With a combination of plenary sessions and posters, keynote presentations, and breakout workshops, the 2022 VASE Conference featured key updates on research related to the development of vaccines against neglected diarrheal pathogens including Shigella, enterotoxigenic Escherichia coli (ETEC), Campylobacter, and Salmonella. The presentations and discussions highlighted the significant impact of these diarrheal pathogens, particularly on the health of infants and young children in low- and middle-income countries, reflecting the urgent need for the development and licensure of new enteric vaccines. Oral and poster presentations at the VASE Conference explored a range of topics, including: the global burden and clinical presentation of disease, epidemiology, and the impact of interventions; the assessment of the value of vaccines against enteric pathogens; preclinical evaluations of vaccine candidates and models of enteric diseases; vaccine candidates in clinical trials and human challenge models; host parameters and genomics that predict responses to infection and disease; the application of new omics technologies for characterization of emerging pathogens and host responses; novel adjuvants, vaccine delivery platforms, and immunization strategies; and strategies for combination/co-administered vaccines. The conference agenda also featured ten breakout workshop sessions on topics of importance to the enteric vaccine field, which are summarized separately. This article reviews key points and highlighted research presented in each of the plenary conference sessions and poster presentations at the 2022 VASE Conference.