A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus

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• 作者：Cindy Tamminga ; Michael Kavanaugh ; Charlotte Fedders ; Santina Maiolatesi ; Neethu Abraham ; Jan Bonhoeffer ; Ulrich Heininger ; Carlos S. Vasquez ; Vasee S. Moorthy ; Judith E. Epstein ; Thomas L. Richie
• 关键词：Clinical trials ; Systematic review ; Vaccines ; Safety reporting ; Adverse events ; Fever
• 刊名：Vaccine
• 出版年：2013
• 出版时间：2 August, 2013
• 年：2013
• 卷：31
• 期：35
• 页码：3628-3635
• 全文大小：1095 K

文摘

Introduction

Malaria, tuberculosis (TB) and human immunodeficiency virus (HIV) are diseases with devastating effects on global public health, especially in the developing world. Clinical trials of candidate vaccines for these diseases are being conducted at an accelerating rate, and require accurate and consistent methods for safety data collection and reporting. We performed a systematic review of publications describing the safety results from clinical trials of malaria, TB and HIV vaccines, to ascertain the nature and consistency of safety data collection and reporting.

Methods

The target for the review was pre-licensure trials for malaria, TB and HIV vaccines published in English from 2000 to 2009. Search strategies were customized for each of the databases utilized (MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and the Database of Reviews and Effects). Data extracted included age of trial participants, vaccine platform, route and method of vaccine administration, duration of participant follow-up, reporting of laboratory abnormalities, and the type, case definitions, severity, reporting methods and internal reporting consistency of adverse events.

Results

Of 2278 publications screened, 124 were eligible for inclusion (malaria: 66, TB: 9, HIV: 49). Safety data reporting was found to be highly variable among publications and often incomplete: overall, 269 overlapping terms were used to describe specific adverse events. 17 % of publications did not mention fever. Descriptions of severity or degree of relatedness to immunization of adverse events were frequently omitted. 26 % (32/124) of publications failed to report data on serious adverse events.

Conclusions

The review demonstrated lack of standardized safety data reporting in trials for vaccines against malaria, TB and HIV. Standardization of safety data collection and reporting should be encouraged to improve data quality and comparability.

Limitations

The search strategy missed studies published in languages other than English and excluded studies reporting on vaccine trials for diseases besides malaria, TB and HIV.