Immunization, Vaccines and Biologicals

WHO Initiative for vaccine research/global malaria programme joint technical expert group (JTEG) on malaria vaccines entering pivotal phase 3 trials & beyond (established April 2009)

Terms of reference

JTEG provides advice to WHO on activities related to the development of malaria vaccines at or nearing the pivotal phase 3 trial stage. The specific responsibilities of the group are to provide recommendations on:

  • The clinical trial data necessary and desirable for evaluation of the public health impact of a malaria vaccine in malaria endemic countries
  • The design, conduct, analyses and interpretation of Phase 2, Phase 3 and Phase 4 trials of malaria vaccines.
  • The duration and nature of follow-up of participants in planned Phase 3 trials of malaria vaccines.
  • The minimum safety and efficacy data to be collected in clinical trials, and data on any impact of malaria vaccines on the immunogenicity of other vaccines, to enable evaluation by WHO for policy recommendations.
  • The evaluation of immunogenicity of malaria vaccines in Phase 3 trials and beyond, in particular with regard to possible development of surrogate markers for efficacy.

Composition

Experts

  • Peter Smith, Chair (London School of Hygiene and Tropical Medicine, UK)
  • Fred Binka (University of Ghana, Ghana)
  • Kalifa Bojang (MRC Laboratories, The Gambia)
  • Blaise Genton (University of Lausanne, Switzerland)
  • Robert Johnson (National Institutes of Allergy and Infectious Disease, USA)
  • Kamini Mendis (Independent Consultant, Colombo, Sri Lanka)
  • Paul Milligan (London School of Hygiene and Tropical Medicine, UK)
  • Malcolm Molyneux (University of Malawi, Malawi)
  • Mahamadou Thera (University of Bamako, Mali)
  • Janet Wittes (Statistics Collaborative Inc., USA)
  • Zulfiqar Bhutta (Aga Khan University, Pakistan)
  • Claire-Anne Siegrist (University of Geneva, Switzerland)

WHO Secretariat

  • Vasee Moorthy (IVR)
  • Andrea Bosman (GMP)
  • Georges Ki-Zerbo (MAL, AFRO)
  • Bartholomew Akanmori (IVD, AFRO)

Declarations of interest

All members completed a declaration of interest. 3 members reported the following interests:

Professor Fred Binka reported working with the Indepth-Network Malaria Clinical Trials Alliance (MCTA), a group which trains personnel and improves infrastructure at African clinical trials sites for conduct of clinical trials of malaria drugs and vaccines. Indepth/MCTA was funded by a $17 million grant from the Bill and Melinda Gates' Foundation (BMGF). The work of Indepth/MCTA included partnering with PATH Malaria Vaccine Initiative (MVI) for site strengthening of RTS,S/AS01 phase 3 clinical trial sites. BMGF are also the main funders of the phase 3 trial of RTS,S/AS01 through support to PATH MVI. In addition Professor Binka reported a research grant for the Indepth Network for Effectiveness and Safety Studies (INESS) for $28 million. This platform is intended to support Phase IV studies of antimalarial drugs. These interests were assessed as non-personal, non-specific and financially significant*.

Professor Malcolm Molyneux reported that he currently serves as Chair of the Independent Data Monitoring Committee for RTS,S/AS01 paediatric clinical trials, for which his institution receives a limited fee. This interest was assessed as non-personal, specific and not financially significant*.

Dr Janet Wittes reported that her institution has performed statistical consulting services for GSK for a study on asthma and another on cardiovascular diseases, totaling less than $50,000. The most recent consulting contract with GSK terminated in 2010. Her institution has also received funding for malaria vaccine-related statistical services from PATH Malaria Vaccine Initiative and from Seattle Biomed. None of this funding relates to the RTS,S malaria vaccine. These interests were assessed as non-personal, non-specific and financially significant*.


* According to WHO's Guidelines for Declaration of Interests (WHO expert), an interest is considered "personal" if it generates financial or non-financial gain to the expert, such as consulting income or a patent. "Specificity" states whether the declared interest is a subject matter of the meeting or work to be undertaken. An interest has "financial significance" if the honoraria, consultancy fee or other received funding, including those received by expert's organization, from any single vaccine manufacturer or other vaccine-related company exceeds 10,000 USD in a calendar year. Likewise, a shareholding in any one vaccine manufacturer or other vaccine-related company in excess of 1,000 USD would also constitute a “significant shareholding”.

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