Immunization standards

Joint inspection of clinical trial of conjugate Meningitis A vaccine
17-19 January 2007 in Bamako, Mali

Background

The Meningitis Vaccine Project (MVP) has started clinical trials in The Gambia and Mali. IVB/QSS Regulatory Pathways has liaised with MVP to coordinate a joint review of the clinical trial application (CTA) involving the two countries and other countries where phase II and phase III trials will be conducted in 2007 and 2008 as a capacity building activity. In preparation, in 2005 the countries attended a workshop to develop the regulatory procedures for submissions of CTAs. These procedures have been used by Mali and Gambia and the submissions by the MVP have been prepared accordingly. The agreement also included consensus to perform an inspection involving representatives from the same countries.

Objectives

Involvement of WHO in the supervision of clinical development has allowed the vaccine regulation group to plan capacity building activities with target countries in advance. This case is used as a model to:

  • implement procedures developed in a recent capacity building activity
  • promote communication among relevant parties (NRA, Ethics Committee, Clinical Research Organisation (CRO) and trial sponsor)
  • provide a regulatory mechanism for review of clinical trial applications using the "regional approach"
  • provide hands-on training, by bringing experts to support NRAs of target countries and other countries in the region that will perform the same activity in the near future (review of clinical trial application).

Participants

Gambia and Mali: 1 person from NRA responsible for technical review of CT application, 1 person from the Ethics Committee. Ghana, Burkina Faso, Ethiopia: 1 person from the NRA responsible for evaluation of application dossiers.

Outcome

The activity included two days of preparation (overview of principles of Good Clinical Practices (GCP), inspection objectives, use of inspection checklist), one and half days inspection at CVD (Center for Vaccine Development), and one and half days for discussion of observations, preparation of draft report and debriefing to CVD and MVP staff.

London School of Hygiene and Tropical Medicine, who also supported the joint review in Banjul, provided support to the regulators. The GCP inspection checklist developed by Developing Countries' Vaccine Regulators Network (DCVRN) was translated into French and tested for the first time and used as a guiding document to prepare and conduct the inspection as well as for the preparation of the report.

The inspectors learned through the process, how to inspect facilities, processes and documents, and reviewed several pieces of documentation. A confidentiality agreement was prepared by WHO for signature by regulators other than from Mali. A draft report was prepared in English and French and presented to MVP and CVD staff the last day and discussed.

With the exception of South Africa, this the first time an African NRA performs a GCP inspection for a vaccine trial. The experience was reported as extremely productive for the clinical trial site as well as for the participating inspectors.

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