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Result Summaries: Herpes Simplex Vaccine

GSK
Study ID
   Phase    Title Summary (Download)
208141/001 phase 1 An open study in healthy Herpes simplex virus (HSV)-positive adults to evaluate the safety of GSK Biologicals’ candidate gD vaccine, with or without 3D MPL (1 citation(s)) Click here to download result summary.
208141/002 phase 2 Study in healthy HSV positive and HSV negative adults to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' herpes simplex (gD) candidate vaccine with or without 3D-MPL adjuvant administered according to a 0,1, 6 month schedule. (1 citation(s)) Click here to download result summary.
208141/004 phase 2 A feasibility study to evaluate the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' Herpes simplex candidate vaccine (gD2t), with Monophosphoryl Lipid A (MPL) and with or without Tween in initially HSV-seronegative subjects. (0 citation(s)) Click here to download result summary.
208141/005 phase 3 A placebo-controlled study to evaluate the efficacy of SmithKline Beecham Biologicals’ herpes simplex candidate vaccine (gD2t) with MPL (Monophosphoryl Lipid A) to prevent genital herpes disease in healthy consorts of subjects with genital herpes disease. (2 citation(s)) Click here to download result summary.
208141/006 phase 2 A double-blind, randomised study to evaluate the reactogenicity and immunogenicity of SmithKline Beecham Biologicals' Herpes Simplex candidate vaccines (gD2t) with MPL (Monophosphoryl Lipid A), (with or without tween) in healthy HSV-seropositive subjects. (0 citation(s)) Click here to download result summary.
208141/008 phase 1/2 An open randomised controlled study to evaluate in initially HSV-seronegative subjects, the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals' Herpes simplex candidate vaccine (gD2t-MPL-QS21) with gD2t-Alum-MPL as control. (0 citation(s)) Click here to download result summary.
208141/009 phase 1/2 An open, randomised controlled study to evaluate - in HSV-seropositive subjects - the safety, reactogenicity and immunogenicity of SmithKline Beecham Biologicals’ Herpes Simplex candidate vaccine (gD2t-MPL-QS-21), with gD-Al-MPL as control. (0 citation(s)) Click here to download result summary.
208141/014 phase 1/2 A double-blind, randomized study to compare, in healthy HSV seronegative subjects, the humoral and cellular immune response of various formulations of herpes simplex candidate vaccines. (0 citation(s)) Click here to download result summary.
208141/015 phase 1/2 Study to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control (0 citation(s)) Click here to download result summary.
208141/016 phase 3 Study to evaluate the safety of GSK Biologicals’ Herpes Simplex candidate vaccine (gD2t) with MPL in HSV seropositive or seronegative subjects without genital herpes disease (3 citation(s)) Click here to download result summary.
208141/017 phase 3 Safety of SmithKline Beecham Biologicals' Herpes Simplex candidate vaccine (gD2t) with MPL & its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease (3 citation(s)) Click here to download result summary.
208141/019 phase 2 A study comparing the immunogenicity of gD Alum MPL candidate herpes vaccines containing gD produced from 2 different cell lines (CHO DHFR and CHO K1) and at different gD CHO K1 production scales (300L and 600L) in healthy adult HSV seronegative subjects. (0 citation(s)) Click here to download result summary.
208141/023 phase 2 A double-blind study to compare between groups, in healthy HSV-seronegative adolescent subjects, the humoral and cellular immune response and the reactogenicity of herpes simplex candidate vaccines containing gD (10µg or 20µg) and 2 doses of Al-MPL. (0 citation(s)) Click here to download result summary.
208141/024 phase 3 A double blind, randomized trial comparing the immunogenicity of 3 commercial scale consistency lots of gD-Alum-MPL vaccine containing CHO K1 gD in healthy HSV seronegative adult subjects. (0 citation(s)) Click here to download result summary.
208141/026 phase 2 Study comparing different doses and schedules of GSK Bio's candidate prophylactic herpes simplex virus vaccine (gD-AS04) in healthy HSV- subjects aged 10-15 and 16-18 yrs to healthy HSV- adults (aged 19-45 yrs) receiving the vaccine on a 0-1-6 mth schedule. (0 citation(s)) Click here to download result summary.
208141/037 phase 3 Safety and reactogenicity of GSK Bio’s prophylactic herpes simplex candidate vaccine with gD-alum-MPL in HSV 1-/2- women who received either alum-MPL or alum as placebo during one of GSK Bio’s phase III studies 208141/005, 208141/016 or 208141/017. (0 citation(s)) Click here to download result summary.
208141/038 phase 3 Safety, reactogenicity, and immunogenicity of GSK Bio’s prophylactic herpes simplex candidate vaccine with gD-alum-MPL in HSV 1-/2- women who received alum-MPL or alum placebo during one of GSK Bio’s Phase III studies 208141/005, 208141/016 or 208141/017. (0 citation(s)) Click here to download result summary.
208141/040_ phase 3 A study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' herpes simplex candidate vaccine (gD2‑AS04) in healthy HSV seronegative and seropositive female subjects aged 10-17 years. (2 citation(s)) Click here to download result summary.
208141/041 phase 3 Extension to study comparing doses and schedules of GSK's candidate prophylactic herpes simplex virus vaccine (gD-AS04) in healthy HSV- subjects aged 10-15 and 16-18 yrs to healthy HSV- adults (aged 19-45 yrs) receiving the vaccine on a 0-1-6 mth schedule. (0 citation(s)) Click here to download result summary.
208141/042 phase 3 Study to Compare Immunogenicity & Safety of 3 comercial Lots of GlaxoSmithKline (GSK) Biologicals’ herpes simplex candidate Vaccine in Healthy HSV-1 & -2 Seronegative (HSV 1-/2-) Females of 10–17 y & Vaccine Immunogenicity in Healthy HSV 1-/2- Females of 10–17 y With Healthy HSV 1-/2- Adult Females (1 citation(s)) Click here to download result summary.
HSV Meta analyses n\a Meta analyses on pregnancy outcomes with respect to the effect of Herpes Simplex Virus (HSV) antigen and of the adjuvant (AS04) (0 citation(s)) Click here to download result summary.