Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
Condition: Genital Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, factorial study to compare the reduction in viral
      shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2
      adjuvant.

      Secondary objectives of the study include:

        -  Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2
           compared to placebo.

        -  Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among
           the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:

             -  Time to first clinical and/or virologic recurrence,

             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last
                dose of vaccine,

             -  Lesion rate (percent of days with genital lesions present) during the
                post-vaccination swabbing periods.

        -  Evaluation of cellular and humoral responses to GEN-003 antigens.

      Additional objectives include:

        -  Assessment of the correlation between immune responses and change in viral shedding or
           impact on clinical disease as defined above.

        -  Determination of the recurrence rate in a subset of subjects not receiving suppressive
           antivirals throughout the study.

      Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive
      days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals.
      Subjects will be followed for safety and immunologic response for 12 months following their
      last dose.
    


Intervention name(s): GEN-003 Vaccine (30μg of each antigen); GEN-003 Vaccine (60μg of each antigen); Matrix-M2 Adjuvant (25μg); Matrix-M2 Adjuvant (50μg); Matrix-M2 Adjuvant (75μg); Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D; HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; 0.9% Normal Saline (NaCl)
Other intervention name(s): HSV Vaccine; HSV Vaccine; MM2; Adjuvant; MM2; Adjuvant; MM2; Adjuvant; 0.9% Normal Saline (NaCl)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HSV; Herpes; genital infection; vaccine