Immunization standards

Joint review of clinical trial application for conjugate Meningitis A vaccine
31 May to 2 June 2006 in Banjul, The Gambia

Background

The Meningitis Vaccine Project (MVP) plans to start phase II clinical trials of Conjugate Meningitis A vaccine manufactured by the Serum Institute of India (SII) 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.

Objectives

Meningitis A Conjugate vaccine phase II clinical trials were initiated in Africa in 2006. 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 "regionlal 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).

Participating countries

The joint review will involve countries that are target for phase II clinical trial in 2006 and countries that are candidates for phase II CT in 2007. They are: The Gambia, Mali, Ghana, Senegal, Burkina Faso and South Africa (A representative from South Africa participated to support the other regulators with their experience and also as a link to the Developing Countries' Vaccine Regulators Network (DCVRN)).

Participants

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

The joint review

The regulators reviewed and assessed the information submitted with the assistance from expert advisers. The review group formulated questions for the representative of MVP, Dr Simonetta Viviani, who attended the consultation session on Friday June 2. Some of the questions were answered ad hoc and for some, MVP was requested to submit additional information to the National Regulatory Authorities (NRAs) of The Gambia and Mali. Since the protocols have been submitted already to the Ethics Committees of both countries it has been agreed that this review by the NRAs will be the final regulatory step for the authorization to commence phase II clinical trials in the above-mentioned countries, upon satisfactory submission of responses and requested information.

This was the first time that sponsors requested NRAs authorization to conduct trials of vaccines, and the first time the NRAs, Ethics Committees and Scientific Committees worked together to assess the CTA (Clinical Trial Application) for a regulatory decision. Gambia and Mali have finalized the process and the trials commenced on schedule since there were no undue delays in the authorization of the clinical trials.

The participants have reported that this activity was extremely helpful and an excellent learning experience, and have requested WHO to coordinate other activities of the kind since they prove even more useful than training courses. The NRAs have understood the importance of coordination among all the relevant parties (NRAs, Scientific Committees and Ethics Committees) in the regulatory decisions concerning the authorization of clinical trials.

The procedure for submission of clinical trial applications developed after the workshop conducted in Addis (September 2005) was tested with this first case. The group has agreed on a list of amendments to make the procedure more efficient. The procedures were further revised, finalized and distributed to African NRAs.

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