Clinical Trial: Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subj

Brief Summary:

This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.

Objectives:

  • To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:

    • Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)
    • 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 follow-up period
    • Antiviral use.
  • To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.