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Malaria Elimination

RTS,S Vaccine Immunology Study

Study of immune correlates of protection against malaria after vaccination with RTS,S/AS01E: a comprehensive immunological arm of a Phase III double-blind, randomized, controlled multi-center trial

Coordinator
Carlota Dobaño

RTS,S is the most promising malaria vaccine candidate, currently in Phase III trial testing in African children. Initial results of the interim analysis have shown that the efficacy of RTS,S is moderate and questions have been raised regarding the duration of protection, which may be affected by differing malaria transmission intensities in trial sites. Moreover, the mode of action of RTS,S remains unclear and for next generation of improved vaccines it is critical to understand the immune mechanisms that RTS,S induces.

Before the initiation of the RTS,S Phase III trial, a group of investigators led by Dr. Carlota Dobaño  came together to develop and conduct a multicentre study, ancillary to the Phase III clinical trial, to investigate the immunological basis of RTS,S-induced immunity. This study is uniquely positioned to study the mechanisms of RTS,S vaccine action and immune correlates of vaccine-induced protection since the Phase III trial is probably the last opportunity in which there is an unvaccinated control group.

The discovery of a correlate of protection will be a major achievement in the search of a more highly efficacious and durable malaria vaccine.

Funding

This study is funded by:

  • MVI/PATH (US)
  • NIAID/NIH (US)
  • EU FP7 (EU)
  • FIS ISCIII (Spain)
  • AGAUR (Catalonia)

Collaborating with

  • Swiss Tropical and Public Health Institute (SwissTPH), Basel, Switzerland, in collaboration with the Ifakara Health Institute, Bagamoyo Research and Training Centre, Tanzania
  • Institute of Tropical Medicine, University of Tübingen Medical School (UKT), Germany, in collaboration with the Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon
  • Noguchi Memorial Institute for Medical Research, College of Health Sciences (NMIMR) in collaboration with the Kintampo Health Research Center (KHRC), Ghana
  • Kenya Medical Research Institute/Walter Reed Project (KEMRI/WRP), Kenya
  • KEMRI/Centers for Disease Control and Prevention (KEMRI/CDC), Kenya
  • Institut de Recherche en Sciences de la Santé / Centre Muraz (IRSS), Burkina Faso
  • Centro de Investigaçao em Saúde de Manhiça (CISM), Mozambique, in collaboration with CRESIB, Spain
  • GlaxoSmithKline (GSK) Rixensart, Belgium
  • Malaria Vaccine Initiative (MVI) - Program for Appropriate Technology in Health (PATH), USA

External Collaborators

  • Center for Vaccinology - Ghent University Hospital (CEVAC), Belgium
  • Radboud University Nijmegen Medical Center (RUNMC), The Netherlands
  • Biomedical Primate Research Centre (BPRC), The Netherlands
  • Progenika Biopharma SA (PGK), Bilbao, Spain
  • Anaxomics Biotech S.L. (AX), Barcelona, Spain
  • Harvard School of Public Health (HSPH), The Broad Institute, Boston, USA
  • Fred Hutchinson Cancer Research Center (FHCRC), Seattle, USA
  • Seattle Biomedical Research Institute (SBIR), Seattle, USA
  • National Institute of Allergy and Infectious Diseases (NIAID), USA
  • Walter Reed Army Institute of Research (WRAIR), USA
  • University of California Irvine (UCI), USA
  • Indiana University – Purdue University Indianapolis, USA
  • New York University (NYU), USA
  • Naval Medical Research Center (NMRC), USA
  • Antigen Discovery Inc (ADi), California, USA

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