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Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area

Polhemus, Mark E., Remich, Shon A., Ogutu, Bernhards R., Waitumbi, John N., Otieno, Lucas, Apollo, Stella, Cummings, James F., Kester, Kent E., Ockenhouse, Christian F., Stewart, Ann, Ofori- Anyinam, Opokua, Ramboer, Isabelle, Cahill, Conor P., Lievens, Marc, Dubois, Marie-Claude, Demoitie, Marie-Ange, Leach, Amanda J., Cohen, Joe, Ballou, W. Ripley and Heppner, D. Gray, Jr. (2009). Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. PLoS One,4(7):e6465-1-e6465-12.

Document type: Journal Article
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IRMA ID 75039815xPUB510
Title Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area
Author Polhemus, Mark E.
Remich, Shon A.
Ogutu, Bernhards R.
Waitumbi, John N.
Otieno, Lucas
Apollo, Stella
Cummings, James F.
Kester, Kent E.
Ockenhouse, Christian F.
Stewart, Ann
Ofori- Anyinam, Opokua
Ramboer, Isabelle
Cahill, Conor P.
Lievens, Marc
Dubois, Marie-Claude
Demoitie, Marie-Ange
Leach, Amanda J.
Cohen, Joe
Ballou, W. Ripley
Heppner, D. Gray, Jr.
Journal Name PLoS One
Publication Date 2009
Volume Number 4
Issue Number 7
ISSN 1932-6203   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-68149092706
Start Page e6465-1
End Page e6465-12
Total Pages 12
Place of Publication United States
Publisher Public Library of Science
HERDC Category C1 - Journal Article (DIISR)
Abstract Background:
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.

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 (1:1:1) 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.

Principal Findings:
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).

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.
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