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Clinical Trial
. 2011 Aug 4:10:223.
doi: 10.1186/1475-2875-10-223.

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

Christine Swysen  1 , Johan Vekemans, Myriam Bruls, Sunny Oyakhirome, Chris Drakeley, Peter Kremsner, Brian Greenwood, Opokua Ofori-Anyinam, Brenda Okech, Tonya Villafana, Terrell Carter, Barbara Savarese, Adriano Duse, Andrea Reijman, Charlotte Ingram, John Frean, Bernhards Ogutu; Clinical Trials Partnership Committee
Collaborators, Affiliations
Clinical Trial

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

Christine Swysen et al. Malar J. .

Abstract

Background: A 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.

Methods: Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners.

Results: A 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.

Conclusion: Major 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 registration: Clinicaltrials.gov NCT00866619.

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Figures

Figure 1
Figure 1
Parasite density counting methodology (method 1).
Figure 2
Figure 2
Parasite density counting: criteria for concordance of readings and determination of final result.
See this image and copyright information in PMC

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