Moorthy V S, McConkey S, Roberts M, Gothard P, Arulanantham N, Degano P, Schneider J, Hannan C, Roy M, Gilbert S C, Peto T E A, Hill A V S
Nuffield Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DU, UK.
Vaccine. 2003 May 16;21(17-18):1995-2002. doi: 10.1016/s0264-410x(02)00771-5.
A series of phase I clinical studies were conducted to evaluate the safety of plasmid DNA and modified vaccinia virus Ankara malaria vaccines. The vaccines each encoded a polyepitope string fused to whole Plasmodium falciparum TRAP antigen. Forty-three healthy adult volunteers received the vaccines alone or in DNA/MVA prime-boost combinations. The DNA vaccine was administered either intramuscularly by needle or intradermally by a needleless delivery device. The MVA vaccine was administered intradermally by needle. The vaccines were well-tolerated by all three routes and in various DNA/MVA immunisation regimes. There were no severe or serious adverse events.
开展了一系列I期临床研究,以评估质粒DNA和改良安卡拉痘苗病毒疟疾疫苗的安全性。这些疫苗各自编码与恶性疟原虫TRAP全抗原融合的多表位串联体。43名健康成年志愿者单独接种疫苗,或采用DNA/MVA初免-加强联合接种方案。DNA疫苗通过针头进行肌肉注射或通过无针给药装置进行皮内注射。MVA疫苗通过针头进行皮内注射。所有三种给药途径以及各种DNA/MVA免疫方案对疫苗的耐受性均良好。未出现严重或重大不良事件。