TY - JOUR
T1 - A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus
AU - Tamminga, Cindy
AU - Kavanaugh, Michael
AU - Fedders, Charlotte
AU - Maiolatesi, Santina
AU - Abraham, Neethu
AU - Bonhoeffer, Jan
AU - Heininger, Ulrich
AU - Vasquez, Carlos S.
AU - Moorthy, Vasee S.
AU - Epstein, Judith E.
AU - Richie, Thomas L.
N1 - Funding Information:
The views expressed in this manuscript are those of the authors and do not necessarily represent the views, position or policy of the World Health Organization, the European Commission, the Department of the Navy, the Department of Defense, nor the U.S. Government. Drs. Tamminga, Dr. Kavanaugh, Richie and Epstein are U.S. military service members. Title 17 U.S.C. §105 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person's official duties. Research at the US Navy was supported by work unit 6000.RAD1.F.A0309 (Malaria Vaccine Research) . The INYVAX project is funded by the European Commission under the Framework Programme 7, project number 223532.
PY - 2013/8/2
Y1 - 2013/8/2
N2 - 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.
AB - 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.
KW - Adverse events
KW - Clinical trials
KW - Fever
KW - Safety reporting
KW - Systematic review
KW - Vaccines
UR - http://www.scopus.com/inward/record.url?scp=84880712695&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2013.01.045
DO - 10.1016/j.vaccine.2013.01.045
M3 - Article
C2 - 23395586
AN - SCOPUS:84880712695
SN - 0264-410X
VL - 31
SP - 3628
EP - 3635
JO - Vaccine
JF - Vaccine
IS - 35
ER -