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NCT03146403

Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection

Terminated Phase 2 Results posted Last updated 19 February 2019
What this trial tests

Phase 2 trial testing GEN-003 in Genital Herpes in 33 participants. Terminated before completion.

Timeline
24 May 2017
Primary endpoint
22 December 2017
11 June 2018

Quick facts

Lead sponsorGenocea Biosciences, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment33
Start date24 May 2017
Primary completion22 December 2017
Estimated completion11 June 2018
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Genocea Biosciences, Inc. — full company profile →

Who can join

Eligibility, any sex, with Genital Herpes or HSV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Days With Genital Herpes Lesions Primary · The 6-month period after vaccination

Subject-reported via electronic diary

GroupValue95% CI
GEN-0032.580.0 – 21.8
Placebo4.230.0 – 13.5
Number of Genital Herpes Recurrences Secondary · The 6-month period after vaccination

Subject-reported via electronic diary

GroupValue95% CI
GEN-0031.500.0 – 6.0
Placebo1.500.0 – 9.0
Number of Subjects Without Genital Herpes Recurrence Secondary · 6 months after vaccination

Subject-reported via electronic diary

No Recurrence
GroupValue95% CI
GEN-0031
Placebo3
With Recurrence
GroupValue95% CI
GEN-00313
Placebo12
Unknown
GroupValue95% CI
GEN-0032
Placebo1
Days Until First Genital Herpes Recurrence Secondary · The 6-month period after vaccination

Subject-reported via electronic diary

GroupValue95% CI
GEN-003256.0 – 85.0
Placebo5117.0 – 116.0
Duration of Genital Herpes Recurrences Secondary · The 6-month period after vaccination

Time in days per genital herpes recurrence

GroupValue95% CI
GEN-0032.831 – 7
Placebo3.401 – 6

Adverse events — posted to ClinicalTrials.gov

Time frame: Local reactions and systemic events were systematically collected for 7 days after the maintenance dose. AEs were recorded for 12 months of followup after the maintenance dose administration.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GEN-003
Serious: 0/16 (0%)
Deaths: 0/16
Placebo
Serious: 0/17 (0%)
Deaths: 0/17
Other adverse events (16 terms — click to expand)

ReactionSystemGEN-003Placebo
Injection Site PainGeneral disorders——
Injection Site TendernessGeneral disorders——
Muscle AchesMusculoskeletal and connective tissue disorders——
FatigueGeneral disorders——
Injection Site SwellingGeneral disorders——
HeadacheNervous system disorders——
ChillsGeneral disorders——
NauseaGastrointestinal disorders——
Injection Site RednessGeneral disorders——
FeverGeneral disorders——
DiarrheaGastrointestinal disorders——
FatigueGeneral disorders——
SinusitisInfections and infestations——
HeadacheNervous system disorders——
Disturbance in attentionGeneral disorders——
FlushingSkin and subcutaneous tissue disorders——

Data from ClinicalTrials.gov NCT03146403 adverse events section.

Sponsor's own description

The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Matrix-M™ adjuvant: A critical component of vaccines for the 21<sup>st</sup> century.
    Stertman L, Palm AE, Zarnegar B, Carow B, et al · · 2023 · cited 72× · PMID 37113023 · DOI 10.1080/21645515.2023.2189885
  2. A review of HSV pathogenesis, vaccine development, and advanced applications.
    Bai L, Xu J, Zeng L, Zhang L, et al · · 2024 · cited 30× · PMID 39207577 · DOI 10.1186/s43556-024-00199-7
  3. Rational Design of Live-Attenuated Vaccines against Herpes Simplex Viruses.
    Stanfield BA, Kousoulas KG, Fernandez A, Gershburg E. · · 2021 · cited 22× · PMID 34452501 · DOI 10.3390/v13081637
  4. Vaccines against Genital Herpes: Where Are We?
    Kim HC, Lee HK. · · 2020 · cited 13× · PMID 32727077 · DOI 10.3390/vaccines8030420
  5. Current landscape in antiviral drug development against herpes simplex virus infections.
    Frejborg F, Kalke K, Hukkanen V. · · 2022 · cited 7× · PMID 39188739 · DOI 10.1002/smmd.20220004
  6. Immunogenicity and Efficacy of a Trivalent HSV-2 gC2, gD2, gE2 Nucleoside-Modified mRNA-LNP Vaccine Against HSV-1 Eye Infection and Neuroinvasion in Mice.
    Chalmin Katz A, Egan KP, Syeda Z, Son S, et al · · 2026 · PMID 41893790 · DOI 10.3390/vaccines14030253

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