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Vaccine composition suitable for use in the Treatment or prophylaxis of Infections of human papilloma virus and herpes simplex virus infections.
专利权人:
GlaxoSmithKline Biologicals SA
发明人:
申请号:
NO2012016
公开号:
NO2012016I2
申请日:
2012.10.08
申请国别(地区):
NO
年份:
2012
代理人:
摘要:
A vaccine composition comprising a herpes simplex virus (HSV) antigen and a human papillomavirus (HPV) antigen in conjunction with an adjuvant which is a preferential stimulator of TH1 cell response, is new. ACTIVITY : Antiviral. MECHANISM OF ACTION : Vaccine. An immunogenicity study was performed in Balb/C mice using four different antigens: human papilloma virus (HPV)16 L1 Virus Like Particle (VLP-16), HPV 18 L1 Virus Like Particle (VLP-18), gD antigen of herpes simplex virus 2 (HSV-2) and hepatitis B surface antigen (HbsAg) formulated with Alum/3D-MPL (3 De-O-acylated monophosphoryl lipid A) (AS04) using pre-adsorbed monobulks of antigen or 3D-MPL on Al(OH) 3 or AlPO 4. 3D-MPL/Al(OH 3), formulations are referred to AS04D while 3D-MPL/AlPO4 based formulations are referred to AS04C. The following vaccines were assessed: VLP16 + VLP1 AS04D, gDAS04D, HbsAS04C, and the potential to combine these vaccines was evaluated. Groups of 10 mice were immunized intramuscularly twice at 3 week intervals with various antigen (Ag) based formulations, e.g. Group A (VLP16 2 micrograms/VLP18 2 micrograms/gD 2 micrograms/3D-MPL 5 micrograms/Al(OH) 3) 50 micrograms), Group B (VLP16 2 micrograms/VLP18 2 micrograms/HBs 2 micrograms/gD 2 micrograms/3D-MPL 5 micrograms/ Al(OH) 3) 40 micrograms/AlPO4 10 micrograms), Group C (gD 2 micrograms/3D-MPL 5 micrograms/ Al(OH) 3) 50 micrograms), Group D (VLP16 2 micrograms/VLP18 2 micrograms/3D-MPL 5 micrograms/Al(OH) 3) 50 micrograms), and Group E (HBs 2 micrograms/3D-MPL 5 micrograms/ AlPO 4 10 micrograms/ Al(OH) 3) 40 micrograms). Antibody response to VLPs, gD and HBs Ag and the isotypic profile induced by vaccination were monitored by ELISA (enzyme linked immunoabsorbant assay) at day 1 post II. At the same timepoint, the cytokine production (interferon-gamma (IFN-gamma)/interleukin-5 (IL-5)) was analyzed after in vitro restimulation of splenic cells with either VLPs, gD or HBs antigens. The anti-VLP16 titers obtained after immunization with the
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