Clinical Trial: Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine

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

Official Title: A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection

Brief 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

Detailed Summary:
Sponsor: Genocea Biosciences, Inc.

Current Primary Outcome: Change in proportion of days with detectable viral shedding [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens [ Time Frame: 33 weeks ]
  • Impact on clinical HSV-2 disease based on time to recurrence and lesion rate [ Time Frame: 53 weeks ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 57 weeks ]


Original Secondary Outcome: Same as current

Information By: Genocea Biosciences, Inc.

Dates:
Date Received: April 11, 2014
Date Started: July 2014
Date Completion:
Last Updated: March 7, 2016
Last Verified: March 2016