Combined vaccine composition

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 combination of VLPs, gD and HBs Ag (group B), were slightly lower than the one obtained with either the combination of VLPs and gD (group A) or the monovalent VLPs formulation (group D) (GMT respectively of 27578 versus 48105 EU/ml versus 44448 EU/ml). Before statistical analysis a T-Grubbs test was applied on each population for data exclusion. Two non-responder mice in groups A and D were eliminated for analysis. The differences observed between the groups were shown as statistically not sign