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GEN-003 Vaccine

Phase 2

Genital Herpes Simplex Type 2 | Vaccines | Infectious Disease |Genocea Biosciences, Inc.|Trials Updated: Jun 1, 2018

GEN-003 Vaccine target and mechanism

ModalityVaccines

Also known as GEN-003

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment490

FDA Designations

No designations recorded

GEN-003 Vaccine clinical trials

GEN-003 Vaccine · 3 trials · 1 indication

Phase 2 2Phase 1/2 1
NCT02300142Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 StudyGenital Herpes Simplex Type 2
COMPLETED37 Analytics
NCT02114060Dose Ranging Safety and Efficacy of Therapeutic HSV-2 VaccineGenital Herpes Simplex Type 2
COMPLETED310 Analytics
PHASE2COMPLETED
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Genital Herpes Simplex Type 2
NCT0230014237
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PHASE2COMPLETED
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
Genital Herpes Simplex Type 2
NCT02114060310
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Study Endpoints

Primary Endpoints

Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
53 weeks
Change in proportion of days with detectable viral shedding
6 weeks
Number of patients with adverse events as a measure of safety and tolerability
57 Weeks

Secondary Endpoints

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

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GEN-003 Vaccine 30μg / Matrix-M 25μgEXPERIMENTALGEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine 30μg / Matrix-M2 50μgEXPERIMENTALGEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine 30μg / Matrix-M2 75μgEXPERIMENTALGEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine 60μg / Matrix-M2 25μgEXPERIMENTALGEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine 60μg / Matrix-M2 50μgEXPERIMENTALGEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine 60μg / Matrix-M2 75μgEXPERIMENTALGEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
PlaceboPLACEBO_COMPARATOR0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection.
Low Dose GEN-003 with Matrix M-2EXPERIMENTAL10µg GEN-003, 50µg Matrix M-2 Adjuvant
Mid Dose GEN-003 with Matrix M-2EXPERIMENTAL30µg GEN-003, 50µg Matrix M-2 Adjuvant
High Dose GEN-003 with Matrix M-2EXPERIMENTAL100µg GEN-003, 50µg Matrix M-2 Adjuvant
Low Dose GEN-003 OnlyEXPERIMENTAL10µg GEN-003
Mid Dose GEN-003 OnlyEXPERIMENTAL30µg GEN-003
High Dose GEN-003 OnlyEXPERIMENTAL100µg GEN-003

Interventions

NameTypeDescription
GEN-003 Vaccine (30μg of each antigen)BIOLOGICALHSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
GEN-003 Vaccine (60μg of each antigen)BIOLOGICALHSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (25μg)BIOLOGICALMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 Adjuvant (50μg)BIOLOGICALMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 Adjuvant (75μg)BIOLOGICALMatrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
PlaceboBIOLOGICAL0.9% Normal Saline (NaCl)
GEN-003 with Matrix M-2BIOLOGICALIM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
GEN-003BIOLOGICALIM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71. 2. Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002. 3. Willing and able...

Countries:United States
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