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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2015
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.
Epistemonikos ID: 83a89d8257e97c37a7915aa7c8cbf484630c89d3
First added on: May 12, 2024