Clinical trial of SE36 malaria vaccine in the endemic area

我们一直致力于开发SE 36疟疾疫苗。要获得疫苗的许可证，在流行国家进行临床试验至关重要。我们计划在疟疾高发的乌干达北部北方的Apac进行临床试验。我们于2005年9月26日至10月1日访问了位于乌干达坎帕拉的MBL（分子生物技术实验室）<th><st>，并与MBL负责Ib期试验的主任托马斯Egwang博士进行了会谈。会议的后续工作，从7日到10日。11月20日，在日内瓦，我们在世界卫生组织热带病研究和培训特别计划（WHO-TDR）中举行了一次试验扩大会议。与会者是J.Karbwang博士（WHO-TDR）、Z.Reed博士（WHO-IVR，疫苗研究倡议）、T.Egwang博士和T.Horii（该赠款的主要负责人）。会议上，我们根据日本Ia期试验的成功结果，讨论了在乌干达进行Ib期试验的详细计划。另一方面，妊娠疟疾是疟疾感染中的一个重要问题。妊娠期疟疾由于妊娠引起的免疫抑制而导致具有高血寄生虫血症的孕妇的危险性疟疾症状，并且由于寄生虫在Palacenta的积累而导致新生儿体重降低。通过与Egwang博士合作，我们研究了孕妇寄生虫血症、新生儿体重与SE 36蛋白抗体滴度之间的相关性。结果显示，孕妇疟疾症状与抗体滴度呈明显负相关。抗体滴度高的孕妇血吸虫血症低，新生儿体重正常。结果表明，SE 36疟疾疫苗对妊娠期疟疾有较好的预防作用。

We have been worked for developing SE36 Malaria vaccine. For licensing the vaccine, the clinical trials in the endemic countries are essential. We are planning the place conducting the clinical trials at Apac, northern Uganda where is highly malaria endemic.We visited MBL (Molecular Biotech Laboratory) in Kampala, Uganda from 26^<th> Sep. to 1^<st> Oct. 2005, and had meeting with Dr.Thomas Egwang, director of MBL for conducting Phase Ib trial. Following up the meeting, From 7th to 10th. Nov. we had an expanded meeting for the trial in WHO-TDR (World Health Organization, Special program for Research and Training in Tropical Diseases) in Geneva. The participants were Dr.J.Karbwang (WHO-TDR), Dr.Z.Reed (WHO-IVR, Initiative for Vaccine Research), Dr.T.Egwang and T.Horii (PI of this grant). In the meeting, we have discussed for the detail plan of Phase Ib trial in Uganda according to the successful results of Phase la trial in Japan.On the other hand, pregnant malaria is an important issue in malaria infection. The pregnant malaria causes risky malaria symptoms of pregnant women with high blood parasitemia because of immuno suppression by pregnancy and lower body weight of new born baby because of the accumulation of parasites at the palacenta. By collaborating with Dr.Egwang, we have studied the correlation between parasitemia of pregnant women, body weight of new born baby and the antibody titers against SE36 protein. The results revealed the clear negative correlation of the pregnant malaria symptoms and the antibody titer. Blood parasitemia of pregnant women and the body weight of new born baby are lower and normal respectively when the women has higher antibody titer. The result strongly suggests that SE36 malaria vaccine is effective against the pregnant malaria.