Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area.
<h4>Background</h4>This study advances the clinical development of the RTS,S/AS01B candidate malaria vaccine to malaria endemic populations. As a primary objective it compares the safety and reactogenicity of RTS,S/AS01B to the more extensively evaluated RTS,S/AS02A vaccine.<h4>Met...
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Public Library of Science (PLoS)
2009
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oai:doaj.org-article:84c5f3aac3754964900009e529047c9f2021-11-25T06:21:17ZEvaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area.1932-620310.1371/journal.pone.0006465https://doaj.org/article/84c5f3aac3754964900009e529047c9f2009-07-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/19649245/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>This study advances the clinical development of the RTS,S/AS01B candidate malaria vaccine to malaria endemic populations. As a primary objective it compares the safety and reactogenicity of RTS,S/AS01B to the more extensively evaluated RTS,S/AS02A vaccine.<h4>Methodology</h4>A Phase IIb, single centre, double-blind, controlled trial of 6 months duration with a subsequent 6 month single-blind follow-up conducted in Kisumu West District, Kenya between August 2005 and August 2006. 255 healthy adults aged 18 to 35 years were randomized (1ratio1ratio1) to receive 3 doses of RTS,S/AS02A, RTS,S/AS01B or rabies vaccine (Rabipur; Chiron Behring GmbH) at months 0, 1, 2. The primary objective was the occurrence of severe (grade 3) solicited or unsolicited general (i.e. systemic) adverse events (AEs) during 7 days follow up after each vaccination.<h4>Principal findings</h4>Both candidate vaccines had a good safety profile and were well tolerated. One grade 3 systemic AE occurred within 7 days of vaccination (RTS,S/AS01B group). No unsolicited AEs or SAEs were related to vaccine. A marked increase in anti-CS antibody GMTs was observed post Dose 2 of both RTS,S/AS01B (31.6 EU/mL [95% CI: 23.9 to 41.6]) and RTS,S/AS02A (16.7 EU/mL [95% CI: 12.9 to 21.7]). A further increase was observed post Dose 3 in both the RTS,S/AS01B (41.4 EU/mL [95% CI: 31.7 to 54.2]) and RTS,S/AS02A (21.4 EU/mL [95% CI: 16.0 to 28.7]) groups. Anti-CS antibody GMTs were significantly greater with RTS,S/AS01B compared to RTS,S/AS02A at all time points post Dose 2 and Dose 3. Both candidate vaccines produced strong anti-HBs responses. Vaccine efficacy in the RTS,S/AS01B group was 29.5% (95% CI: -15.4 to 56.9, p = 0.164) and in the RTS,S/AS02A group 31.7% (95% CI: -11.6 to 58.2, p = 0.128).<h4>Conclusions</h4>Both candidate malaria vaccines were well tolerated over a 12 month surveillance period. A more favorable immunogenicity profile was observed with RTS,S/AS01B than with RTS,S/AS02A.<h4>Trial registration</h4>Clinicaltrials.gov NCT00197054.Mark E PolhemusShon A RemichBernhards R OgutuJohn N WaitumbiLucas OtienoStella ApolloJames F CummingsKent E KesterChristian F OckenhouseAnn StewartOpokua Ofori-AnyinamIsabelle RamboerConor P CahillMarc LievensMarie-Claude DuboisMarie-Ange DemoitieAmanda LeachJoe CohenW Ripley BallouD Gray HeppnerPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 4, Iss 7, p e6465 (2009) |
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| spellingShingle |
Medicine R Science Q Mark E Polhemus Shon A Remich Bernhards R Ogutu John N Waitumbi Lucas Otieno Stella Apollo James F Cummings Kent E Kester Christian F Ockenhouse Ann Stewart Opokua Ofori-Anyinam Isabelle Ramboer Conor P Cahill Marc Lievens Marie-Claude Dubois Marie-Ange Demoitie Amanda Leach Joe Cohen W Ripley Ballou D Gray Heppner Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. |
| description |
<h4>Background</h4>This study advances the clinical development of the RTS,S/AS01B candidate malaria vaccine to malaria endemic populations. As a primary objective it compares the safety and reactogenicity of RTS,S/AS01B to the more extensively evaluated RTS,S/AS02A vaccine.<h4>Methodology</h4>A Phase IIb, single centre, double-blind, controlled trial of 6 months duration with a subsequent 6 month single-blind follow-up conducted in Kisumu West District, Kenya between August 2005 and August 2006. 255 healthy adults aged 18 to 35 years were randomized (1ratio1ratio1) to receive 3 doses of RTS,S/AS02A, RTS,S/AS01B or rabies vaccine (Rabipur; Chiron Behring GmbH) at months 0, 1, 2. The primary objective was the occurrence of severe (grade 3) solicited or unsolicited general (i.e. systemic) adverse events (AEs) during 7 days follow up after each vaccination.<h4>Principal findings</h4>Both candidate vaccines had a good safety profile and were well tolerated. One grade 3 systemic AE occurred within 7 days of vaccination (RTS,S/AS01B group). No unsolicited AEs or SAEs were related to vaccine. A marked increase in anti-CS antibody GMTs was observed post Dose 2 of both RTS,S/AS01B (31.6 EU/mL [95% CI: 23.9 to 41.6]) and RTS,S/AS02A (16.7 EU/mL [95% CI: 12.9 to 21.7]). A further increase was observed post Dose 3 in both the RTS,S/AS01B (41.4 EU/mL [95% CI: 31.7 to 54.2]) and RTS,S/AS02A (21.4 EU/mL [95% CI: 16.0 to 28.7]) groups. Anti-CS antibody GMTs were significantly greater with RTS,S/AS01B compared to RTS,S/AS02A at all time points post Dose 2 and Dose 3. Both candidate vaccines produced strong anti-HBs responses. Vaccine efficacy in the RTS,S/AS01B group was 29.5% (95% CI: -15.4 to 56.9, p = 0.164) and in the RTS,S/AS02A group 31.7% (95% CI: -11.6 to 58.2, p = 0.128).<h4>Conclusions</h4>Both candidate malaria vaccines were well tolerated over a 12 month surveillance period. A more favorable immunogenicity profile was observed with RTS,S/AS01B than with RTS,S/AS02A.<h4>Trial registration</h4>Clinicaltrials.gov NCT00197054. |
| format |
article |
| author |
Mark E Polhemus Shon A Remich Bernhards R Ogutu John N Waitumbi Lucas Otieno Stella Apollo James F Cummings Kent E Kester Christian F Ockenhouse Ann Stewart Opokua Ofori-Anyinam Isabelle Ramboer Conor P Cahill Marc Lievens Marie-Claude Dubois Marie-Ange Demoitie Amanda Leach Joe Cohen W Ripley Ballou D Gray Heppner |
| author_facet |
Mark E Polhemus Shon A Remich Bernhards R Ogutu John N Waitumbi Lucas Otieno Stella Apollo James F Cummings Kent E Kester Christian F Ockenhouse Ann Stewart Opokua Ofori-Anyinam Isabelle Ramboer Conor P Cahill Marc Lievens Marie-Claude Dubois Marie-Ange Demoitie Amanda Leach Joe Cohen W Ripley Ballou D Gray Heppner |
| author_sort |
Mark E Polhemus |
| title |
Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. |
| title_short |
Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. |
| title_full |
Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. |
| title_fullStr |
Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. |
| title_full_unstemmed |
Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. |
| title_sort |
evaluation of rts,s/as02a and rts,s/as01b in adults in a high malaria transmission area. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2009 |
| url |
https://doaj.org/article/84c5f3aac3754964900009e529047c9f |
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