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Safety of the RTS,S/AS02A malaria vaccine in Mozambican children during a Phase IIb trial

Sacaral, Jahit, Aponte, John J., Aide, Pedro, Mandomando, Inacio, Bassat, Quique, Guinovart, Caterina, Leach, Amanda J., Milman, Jessica, Macete, Eusebio, Ofori-Anyiname, Opokua, Thonnard, Joelle, Corachan, Sabine, Dubois, Marie-Claude, Lievens, Marc, Dubovsky, Filip, Ballou, W. Ripley, Cohen, Joe and Alonso, Pedro L. (2008). Safety of the RTS,S/AS02A malaria vaccine in Mozambican children during a Phase IIb trial. Vaccine,26(2):174-184.

Document type: Journal Article

IRMA ID 75039815xPUB413
Title Safety of the RTS,S/AS02A malaria vaccine in Mozambican children during a Phase IIb trial
Author Sacaral, Jahit
Aponte, John J.
Aide, Pedro
Mandomando, Inacio
Bassat, Quique
Guinovart, Caterina
Leach, Amanda J.
Milman, Jessica
Macete, Eusebio
Ofori-Anyiname, Opokua
Thonnard, Joelle
Corachan, Sabine
Dubois, Marie-Claude
Lievens, Marc
Dubovsky, Filip
Ballou, W. Ripley
Cohen, Joe
Alonso, Pedro L.
Journal Name Vaccine
Publication Date 2008
Volume Number 26
Issue Number 2
ISSN 0264-410X   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-37449027991
Start Page 174
End Page 184
Total Pages 10
Place of Publication United Kingdom
Publisher Elsevier Ltd
HERDC Category C1 - Journal Article (DIISR)
Abstract RTS,S/AS02A is a pre-erythrocytic vaccine candidate based on the Plasmodium falciparum circumsporozoite surface antigen and is currently the most advanced malaria vaccine candidate in development. A proof of concept phase IIb trial of the RTS,S/AS02A in Mozambican children aged 1-4 years determined a vaccine efficacy against risk of clinical malaria of 35.3% (95% CI 21.6-46.6; p<0.0001) and against severe malaria of 48.6% (95% CI 12.3-71.0; p=0.02). We evaluated the safety of the RTS,S/AS02A vaccine. 2022 children that received at least one vaccine dose of RTS,S/AS02A or control vaccines were included in the intention to treat safety analysis. Vaccine safety was evaluated using active and passive follow-up. Participants were observed for at least 1h after each dose. Trained field workers visited children at home daily for the next 3 days to record solicited and unsolicited local and general symptoms. Investigators followed-up participants with severe adverse events until month 21. Overall, we recorded 1712 unsolicited adverse events after vaccination, 53% in the intervention and 47% in the control group. Most unsolicited adverse events reported with RTS,S/AS02A were self-limited, and participants recovered without sequelae. Local reactogenicity increased with the number of doses. The proportion of children experiencing serious adverse events was lower in the RTS,S/AS02A recipients compared to the control group (Engerix-Btrade mark or Prevnartrade mark and Hiberixtrade mark). Overall, these results indicate that the RTS,S/AS02A vaccine has a good safety profile and well tolerated when given in three doses to semi-immune children living in malaria-endemic areas.
Keywords Malaria
Vaccine
RTS,S/AS02A
Safety
Mozambique
DOI http://dx.doi.org/10.1016/j.vaccine.2007.11.003   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
 
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