Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

Malaria Journal

Methodology

Charlotte Ingram¹  Andrea Reijman¹  Opokua Ofori-Anyinam²  Johan Vekemans²  Christine Swysen²  Myriam Bruls²  Brenda Okech²  Sunny Oyakhirome³  Peter Kremsner³  Brian Greenwood⁴  Chris Drakeley⁴  Bernhards Ogutu⁵  John Frean⁶  Tonya Villafana⁷  Terrell Carter⁷  Barbara Savarese⁷  Adriano Duse⁸ 

[1] Contract Laboratory Services, Johannesburg, South Africa;GlaxoSmithKline Biologicals, Rixensart, Belgium;Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany;Albert Schweitzer Hospital, Kumasi, Gabon;London School of Hygiene and Tropical Medicine, University of London, London, UK;Malaria Clinical Trials Alliance (MCTA), INDEPTH Network, Accra, Ghana;National Health Laboratory Service, National Institute for Communicable Diseases, Johannesburg, South Africa;PATH Malaria Vaccine Initiative, Washington, USA;University of the Witwatersrand Medical School, Johannesburg, South Africa;

关键词: Malaria;    Quality Control Sample;    Parasite Density;    Malaria Vaccine;    External Quality Assessment;   

DOI  :  10.1186/1475-2875-10-223

 received in 2011-03-03, accepted in 2011-08-04,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundA pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres.MethodsStandardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners.ResultsA robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials.ConclusionMajor efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials.Trial registrationClinicaltrials.gov NCT00866619

【 授权许可】

CC BY   
© Swysen et al; licensee BioMed Central Ltd. 2011