Genital Herpes Simplex Type 2 Clinical Trial
Official title:
A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection
Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts
of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each
cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:
1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)
2. GEN-003: Antigens alone
3. Placebo (DPBS diluent)
Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot
Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon
successful review of data from the Pilot Group through Day 7 after immunization. Dose
escalation to the next dose level Cohort proceeds after evaluation of safety data from all
patients in the prior Cohort and only after all specified safety criteria are met. The total
numbers of patients in each Group and Cohort are as follows:
- 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
- Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)
Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at
3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done
twice daily for 28 days prior to the first immunization (baseline shedding), and again
following the last immunization. Follow-up for safety monitoring will be conducted for 12
months after the last immunization.
n/a
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