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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
143
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
University of Alabama Vaccine Research Unit
Birmingham, Alabama, United States
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Westover Heights Clinic
Portland, Oregon, United States
Center for Clinical Studies - Houston
Houston, Texas, United States
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, United States
UW Virology Research Clinic
Seattle, Washington, United States
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 57 Weeks
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Time frame: 33 weeks
Change in proportion of days with detectable viral shedding
Time frame: 6 weeks
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