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

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• 作者：Jahit Sacarlal ; John J. Aponte ; Pedro Aide ; Iná ; cio M ; om ; o ; Quique Bassat ; Caterina Guinovart ; Am ; a Leach ; Jessica Milman ; Eusebio Macete ; Mateu Espasa ; Opokua Ofori-Anyinam ; Joelle Thonnard ; Sabi
• 关键词：Malaria ; Vaccine ; RTS ; S/AS02A ; Safety ; Mozambique
• 刊名：Vaccine
• 出版年：2008
• 出版时间：10 January 2008
• 年：2008
• 卷：26
• 期：2
• 页码：174-184
• 全文大小：470 K

文摘

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 1 h 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-B™ or Prevnar™ and Hiberix™). 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.