The WHO Global Programme for Vaccines and Immunization Vaccine Trial Registry

Article excerpt

Introduction

The WHO Global Programme for Vaccines and Immunization (GPV) was established in 1994. To strengthen its research capabilities a GPV Vaccine Research and Development Unit was set up by merging two existing vaccine research groups: the WHO/UNDP Programme for Vaccine Development, responsible for funding US$ 3-5 million in vaccine research annually over the period 1984-93 (1); and the research component of the WHO Expanded Programme on Immunization (EPI), which funded about US$ 1 million in vaccine research annually over the period 1988-93 (2).

Following the establishment of the GPV Vaccine Research and Development Unit, a panel of outside experts advised that it initiate a registry of vaccine trials to improve internal management of WHO-supported studies; to predict resource needs for future studies; to identify sites in developing countries with previous experience in conducting vaccine trials: and to compare vaccine trial methodologies. There is good precedent for such registries of clinical trials, which permit a more efficient overview of clinical research. Most registries have been established to facilitate research, especially by encouraging development of collaborative studies and multicentre studies, use of standardized study protocols, and improvements in study methodology. A global review identified 24 registries of clinical trials that were active in 1990 (3); about half of these registries were devoted to studies of treatments for cancer or acquired immunodeficiency syndrome (AIDS), but none was focused on vaccine trials.

Since 1990, general interest in clinical trials has increased and several vaccine trial registries have been set up. For example, in 1994, the European Community established a registry of European vaccine trials (4); and the Cochrane Collaboration has fostered a series of clinical trial databases and reviews (5, 6). One review associated with the Cochrane Collaboration examined the number and quality of vaccine trials published in the journal Vaccine (7).

This update describes the WHO/GPV Vaccine Trial Registry, which was established in 1995 (8). Discussed are the spectrum of vaccines and diseases addressed by the trials in the registry; the geographical distribution of the study sites; design characteristics of completed trials; and the types of contributions WHO has made to these studies.

Methods

The WHO/GPV Vaccine Trial Registry has enrolled trials from three main sources: those conducted and/ Or sponsored by WHO/EPI from the time of its establishment in 1974 until 1993; those conducted and/ or sponsored by the WHO Programme for Vaccine Development from 1984 until 1993; and those conducted and/or sponsored by WHO/GPV since 1994. In addition, the Division of Child Health and Development has enrolled selected vaccine trials that will ultimately provide data relevant for immunization programme managers. To date, the WHO/GPV registry does not include vaccine trials sponsored by the WHO Special Programme for Research and Training in Tropical Disease or by the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The registry covers only studies of human subjects, including the following: vaccine trials completed; trials in-progress; trials that are expected to start within the next 12 months; and trials that have been discontinued. The information collected for each vaccine trial includes the following: the principal investigator; the country where the trial was conducted; type of vaccine studied (including name of manufacturer, vaccine formulation, and route of administration); age at enrolment; number of subjects enrolled; number of subjects completing the trial; type of study; method of subject allocation; type of comparison group; masking; duration of follow-up; outcome(s) measured; institutions collaborating in the study; contributions by WHO; and details of publications resulting from the study.

Data for the registry were abstracted from WHO records, including study proposals, annual reports, and reports of site visits. …