Genital Herpes Simplex Type 2 Clinical Trial
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
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 be followed for safety and immunologic response for 12 months following their
last dose.
n/a
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