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

Swysen, C., Vekemans, J., Bruls, M., Oyakhirome, S., Drakeley, C., Kremsner, P., Greenwood, B., Ofori-Anyinam, O., Okech, B., Villafana, T., Carter, T., Savarese, B., Duse, A., Reijman, A., Ingram, C., Frean, J. and Ogutu, B. (2011) Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine. Malaria journal, 10. p. 223. ISSN 1475-2875

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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.

Item Type: Article
Keywords: Malaria vaccine, malaria control, malaria diagnosis, immunology
Subjects: Health Systems > Laboratories, diagnostics, equipment
Divisions: Ifakara Health Institute > Health Systems
Depositing User: Mr Joseph Madata
Date Deposited: 01 Aug 2012 06:23
Last Modified: 16 Aug 2012 15:57
URI: http://ihi.eprints.org/id/eprint/53

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