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Matrix-M2 Adjuvant

Phase 2

Genital Herpes Simplex Type 2 | Biologics | Infectious Disease |Genocea Biosciences, Inc.|Trials Updated: May 22, 2018

Matrix-M2 Adjuvant target and mechanism

ModalityBiologics

Also known as Matrix-M2

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

Matrix-M2 Adjuvant clinical trials

Matrix-M2 Adjuvant · 1 trial · 1 indication

Phase 2 1
NCT02515175Evaluating New Formulation of Therapeutic HSV-2 VaccineGenital Herpes Simplex Type 2
COMPLETED131 Analytics
PHASE2COMPLETED
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Genital Herpes Simplex Type 2
NCT02515175131
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Study Endpoints

Primary Endpoints

Change in HSV-2 viral shedding rate
baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)

Secondary Endpoints

Immunogenicity measured by humoral (antibody) responses to vaccine antigens
13 weeks
Impact on clinical HSV-2 disease based on time to first recurrence
64 weeks
Number of patients with adverse events as a measure of safety and tolerability
64 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GEN-003 60ug / Matrix-M2 50ugEXPERIMENTALGEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
GEN-003 60ug / Matrix-M2 75ugEXPERIMENTALGEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
PlaceboPLACEBO_COMPARATOR0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection

Interventions

NameTypeDescription
Matrix-M2BIOLOGICALMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003BIOLOGICALHSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
PlaceboDRUG0.9% Normal Saline
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria * A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppres...

Countries:United States
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