Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine
<p>Abstract</p> <p>Background</p> <p>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 internationa...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2011-08-01
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| Series: | Malaria Journal |
| Online Access: | http://www.malariajournal.com/content/10/1/223 |
| _version_ | 1811319016651751424 |
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| author | Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards |
| author_facet | Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards |
| author_sort | Carter Terrell |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> <p>Trial registration</p> <p>Clinicaltrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00866619">NCT00866619</a></p> |
| first_indexed | 2024-04-13T12:35:02Z |
| format | Article |
| id | doaj.art-008158d7418049a6a85bf316e6e6a71b |
| institution | Directory Open Access Journal |
| issn | 1475-2875 |
| language | English |
| last_indexed | 2024-04-13T12:35:02Z |
| publishDate | 2011-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Malaria Journal |
| spelling | doaj.art-008158d7418049a6a85bf316e6e6a71b2022-12-22T02:46:41ZengBMCMalaria Journal1475-28752011-08-0110122310.1186/1475-2875-10-223Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccineCarter TerrellVillafana TonyaOkech BrendaOfori-Anyinam OpokuaGreenwood BrianKremsner PeterDrakeley ChrisOyakhirome SunnyBruls MyriamVekemans JohanSwysen ChristineSavarese BarbaraDuse AdrianoReijman AndreaIngram CharlotteFrean JohnOgutu Bernhards<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p> <p>Trial registration</p> <p>Clinicaltrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00866619">NCT00866619</a></p>http://www.malariajournal.com/content/10/1/223 |
| spellingShingle | Carter Terrell Villafana Tonya Okech Brenda Ofori-Anyinam Opokua Greenwood Brian Kremsner Peter Drakeley Chris Oyakhirome Sunny Bruls Myriam Vekemans Johan Swysen Christine Savarese Barbara Duse Adriano Reijman Andrea Ingram Charlotte Frean John Ogutu Bernhards Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine Malaria Journal |
| title | Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
| title_full | Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
| title_fullStr | Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
| title_full_unstemmed | Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
| title_short | Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine |
| title_sort | development of standardized laboratory methods and quality processes for a phase iii study of the rts s as01 candidate malaria vaccine |
| url | http://www.malariajournal.com/content/10/1/223 |
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