Clinical trial of SE36 malaria vaccine in the endemic area

• Project/Area Number: 17256003
• Research Category: Grant-in-Aid for Scientific Research (A)
• Allocation Type: Single-year Grants
• Section: 海外学術
• Research Field: Parasitology (including Sanitary zoology)
• Research Institution: Osaka University
• Principal Investigator: HORII Toshihiro Osaka University, Research Institute for Microbial Diseases, Professor, 微生物病研究所, 教授 (80142305)
• Co-Investigator(Kenkyū-buntansha): ARISUE Nobuko Osaka University, Research Institute for Microbial Diseases, Research Associate, 微生物病研究所, 助手 (00242339) ; TAI Kumiko Osaka University, Research Institute for Microbial Diseases, Technical Official, 微生物病研究所, 教務職員 (00187907) ; ISHIBASHI Masahide THE Research Foundation for Microbial Diseases of Osaka University, Kanonji Institute, Director, 観音寺研究所, 所長(研究職) (70029776)
• Project Period (FY): 2005 – 2006
• Project Status: Completed (Fiscal Year 2006)
• Budget Amount: ¥40,950,000 (Direct Cost: ¥31,500,000、Indirect Cost: ¥9,450,000); Fiscal Year 2006: ¥19,630,000 (Direct Cost: ¥15,100,000、Indirect Cost: ¥4,530,000); Fiscal Year 2005: ¥21,320,000 (Direct Cost: ¥16,400,000、Indirect Cost: ¥4,920,000)
• Keywords: malaria vaccine / SE36 protein / Plasmodium falciparum / clinical trial / epidemiological research

Research Abstract

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.

Research Products

• [Journal Article] Phylogeny and evolution of SERA multigene family in the genus Plasmodium. (2007)
  • Author(s): Arisue N., Hirai M., Arai M., Matsuoka H., Horii T.
  • Journal Title: J. Mol. Evol. (In press)
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Pathological role of Toll-like receptor signaling in cerebral malaria. (2007)
  • Author(s): Coban C, Ishii KJ, Uematsu S, Arisue N, Sato S, Yamamoto M, Kawai T, Takeuchi O, Hisaeda H, Horii T, Akira S.
  • Journal Title: Int Immunol. 19 Pages: 67-79
  • NAID: 10020112335
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Phylogeny and evolution of SERA multigene family in the genus Plasmodium. (2007)
  • Author(s): Arisue N., Hirai M., Arai M., Matsuoka H., Horii T.
  • Journal Title: J.Mol.Evol. (In press)
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Pathological role of Toll-like receptor signaling in cerebral malaria. (2007)
  • Author(s): Coban C, Ishii KJ, Uematsu S, Arisue N, Sato S, Yamamoto M, Kawai T, Takeuchi 0, Hisaeda H, Horii T, Akira S.
  • Journal Title: Int Immunol. 19(1) Pages: 67-79
  • NAID: 10020112335
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Pathological role of Toll-like receptor signaling in cerebral malaria. (2007)
  • Author(s): Coban C, Ishii KJ, Uematsu S, Arisue N, Sato S, Yamamoto M, Kawai T, Takeuchi O, Hisaeda H, Horii T, Akira S
  • Journal Title: Int Immunol. 19 Pages: 67-79
  • NAID: 10020112335
• [Journal Article] Crystallization and preliminary crystallographic analysis of orotidine 5'-monophosphate decarboxylase from the human malaria parasite Plasmodium falciparum. (2006)
  • Author(s): Krungkrai SR, Tokuoka K, Kusakari Y, Inoue T, Adachi H, Matsumura H, Takano K, Murakami S, Mori Y, Kai Y, Krungkrai J, Horii T.
  • Journal Title: Acta Crystallograph Sect F Struct Biol Cryst Commun. 62(Pt 6) Pages: 542-545
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Plasmodium vivax serine repeat antigen (SERA) multigene family exhibits similar expression patterns in independent infections. (2006)
  • Author(s): Palacpac NM, Leung BW, Arisue N, Tanabe K, Sattabongkot J, Tsuboi T, Torii M, Udomsangpetch R, Horii T
  • Journal Title: Mol Biochem Parasitol. 150(2) Pages: 353-358
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] High titers of IgG antibodies against Plasmodium falciparum Serine repeat antigen 5 (SERA5) are associated with protection against severe malaria in Ugandan children. (2006)
  • Author(s): Okech B., Mujuzi G., Ogwal A., Shirai H., Horii T., Egwang T.G.
  • Journal Title: Am J Trop Med Hyg. 74(2) Pages: 191-197
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Crystallization and preliminary crystallographic analysis of orotidine 5'-monophosphate decarboxylase from the human malaria parasite Plasmodium falciparum (2006)
  • Author(s): Krungkrai SR, Tokuoka K, Kusakari Y, Inoue T, Adachi H, Matsumura H, Takano K, Murakami S, Mori Y, Kai Y, Krungkrai J, Horii T.
  • Journal Title: Acta Crystallograph Sect F Struct Biol Cryst Commun. 62(Pt 6) Pages: 542-54
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Plasmodium vivax serine repeat antigen (SERA) multigene family exhibits similar expression patterns in independent infections. (2006)
  • Author(s): Palacpac NM, Leung BW, Arisue N, Tanabe K, Sattabongkot J, Tsuboi T, Torii M, Udomsangpetch R, Horii T.
  • Journal Title: Mol Biochem Parasitol. 150(2) Pages: 353-358
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Crystallization and preliminary crystallographic analysis of orotidine 5'-monophosphate decarboxylase from the human malaria parasite Plasmodium falciparum. (2006)
  • Author(s): Krungkrai SR, Tokuoka K, Kusakari Y, Inoue T, Adachi H, Matsumura H, Takano K, Murakami S, Mori Y, Kai Y, Krungkrai J, Horii T
  • Journal Title: Acta Crystallograph Sect F Struct Biol Cryst Commun. 62(Pt 6) Pages: 542-545
• [Journal Article] Plasmodium falciparum serine-repeat antigen (SERA) forms a homodimer through disulfide bond. (2005)
  • Author(s): Sato D., Li J., Mitamura T., Horii T.
  • Journal Title: Parasitol Int. 54(4) Pages: 261-265
  • NAID: 10017125587
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Toll-Like Receptor 9 Mediates Innate Immune Activation by Malaria Pigment Hemozoin. (2005)
  • Author(s): Coban C, Ishii KJ, Kawai T, Hemmi H, Sato S, Uematsu S, Yamamoto M, Takeuchi O, Itagaki S, Kumar N, Horii T, Akira S
  • Journal Title: J. Exp. Med. 201(1) Pages: 19-25
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Plasmodium falciparum serine-repeat antigen (SERA) forms a homodimer through disulfide bond. (2005)
  • Author(s): Sato D., Li J., Mitamura T., Horii T.
  • Journal Title: Parasitol Int 54(4) Pages: 261-265
  • NAID: 10017125587
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Toll-Like Receptor 9 Mediates Innate Immune Activation by Malaria Pigment Hemozoin. (2005)
  • Author(s): Coban C, Ishii KJ, Kawai T, Hemmi H, Sato S, Uematsu S, Yamamoto M, Takeuchi O, Itagaki S, Kumar N, Horii T, Akira S
  • Journal Title: J.Exp.Med. 201(1) Pages: 19-25
• [Journal Article] Toll-Like Receptor 9 Mediates Innate Immune Activation by Malaria Pigment Hemozoin.
  • Author(s): Coban C, Ishii KJ, Kawai T, Hemmi H, Sato S, Uematsu S, Yamamoto M, Takeuchi 0, Itagaki S, Kumar N, Horii T, Akira S
  • Journal Title: J.Exp.Med. 201(1) Pages: 19-252005
  • Description: 「研究成果報告書概要(欧文)」より