Clinical phase II and III studies of an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66 cell culture platform.

Background: We have developed an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66 cell culture platform (KD-295).

Objectives: In accordance with Japanese guidelines for development of pandemic prototype vaccines, the phase II study was conducted in a double-blind, randomized, parallel-group comparison study and the phase III study was conducted in an open-label, non-randomized, uncontrolled study.

Methods: Healthy adult volunteers aged 20 - 64 years enrolled in the phase II and III studies (N = 248 and N = 369) received KD-295 intramuscularly twice with a 21-day interval.

A clinical phase I study of an EB66 cell-derived H5N1 pandemic vaccine adjuvanted with AS03.

Background: We conducted a phase I clinical trial of a cell culture-derived AS03-adjuvanted influenza vaccine containing HA antigen (A/Indonesia/05/2005(H5N1)/PR8-IBCDC-RG2) derived from EB66 cells (KD-295).

Methods: Healthy male adult volunteers (20-40 years old, N=60) enrolled in the study were divided into 3 groups, the MA group (3.8 μg of HA+AS03), HA group (7.

The protective effect of selenoprotein P on injury in rat liver transplantation.

Background/aims: Selenoprotein P (SeP), a plasma protein, is considered to have a protective effect against various organ damages. We investigated whether addition of SeP to storage solution could attenuate cold ischemia/reperfusion injury (IRI) in rat liver transplantation.

Methodology: After 24 hrs cold preservation in either University of Wisconsin (UW) solution with or without SeP (1 micromol/L or 10 micromol/L), the liver was flushed with warm lactated Ringer's solution.

Successful treatment of collagen-induced arthritis in non-human primates by chimeric anti-osteopontin antibody.

The presence of thrombin-cleaved form of osteopontin well correlated with various inflammatory disease activities in not only rodents, but also humans. We previously demonstrated that the blocking of the interaction of a cryptic epitope within osteopontin, which is exposed by thrombin cleavage, with its integrins by specific antibody recognizing cryptic epitope of mouse osteopontin, could significantly inhibits the development of arthritis in mice. We generated a murine monoclonal antibody, 2K1, specifically recognizing a cryptic epitope of human osteopontin, SVVYGLR.

Identification of selenoprotein P fragments as a cell-death inhibitory factor.

Megakaryoblastoma (Dami cells) cultured in a serum-free medium containing albumin, proliferated for three days but died on the fourth day. This cell death was not observed when human plasma was added, suggesting that human plasma contains a cell-death inhibitory factor. In order to identify this factor, we purified it from human plasma.

Expression and function of NJ-1 surface antigen in megakaryopoiesis.

Immunostaining with NJ-1 monoclonal antibody (MoAb) revealed that NJ-1 is expressed on megakaryocytes (MKs). NJ-1-positive and lineage-negative progenitor cells have a higher potency to proliferate and differentiate into MKs. MKs were divided into NJ-1(+)MKs and NJ-1(-)MKs.

Critical role of the TIE2 endothelial cell receptor in the development of definitive hematopoiesis.

We have investigated the function of TIE2/TEK receptor tyrosine kinase in the development of definitive hematopoiesis. In the vitelline artery at 9.5 days postcoitum (d.