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Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine

NCT02114060 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2017-10-16

No results posted yet for this study

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 be followed for safety and immunologic response for 12 months following their last dose.

Conditions

  • Genital Herpes Simplex Type 2

Interventions

BIOLOGICAL

GEN-003 Vaccine (30μg of each antigen)

HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D

BIOLOGICAL

GEN-003 Vaccine (60μg of each antigen)

HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D

BIOLOGICAL

Matrix-M2 Adjuvant (25μg)

Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

BIOLOGICAL

Matrix-M2 Adjuvant (50μg)

Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

BIOLOGICAL

Matrix-M2 Adjuvant (75μg)

Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

BIOLOGICAL

Placebo

0.9% Normal Saline (NaCl)

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02114060 on ClinicalTrials.gov