NCT02515175

A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection

Completed Phase 2 Last updated 21 May 2018

What this trial tests

Phase 2 trial testing Matrix-M2 in Genital Herpes Simplex Type 2 in 131 participants. Completed in 25 May 2017.

Timeline

1 November 2015

Primary endpoint
1 July 2016

25 May 2017

Quick facts

Lead sponsor	Genocea Biosciences, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	131
Start date	1 November 2015
Primary completion	1 July 2016
Estimated completion	25 May 2017
Sites	8 locations across United States

Drugs / interventions tested

• Matrix-M2 — full drug profile →
• GEN-003 — full drug profile →
• Placebo

Conditions studied

• Genital Herpes Simplex Type 2 — all drugs for Genital Herpes Simplex Type 2 →

Sponsor

Genocea Biosciences, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Genital Herpes Simplex Type 2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.

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^st 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. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease.
   Bernstein DI, Flechtner JB, McNeil LK, Heineman T, et al · · 2019 · cited 25× · PMID 31103365 · DOI 10.1016/j.vaccine.2019.05.009
4. An updated review of HSV-1 infection-associated diseases and treatment, vaccine development, and vector therapy application.
   Su D, Han L, Shi C, Li Y, et al · · 2024 · cited 20× · PMID 39508503 · DOI 10.1080/21505594.2024.2425744
5. Vaccines against Genital Herpes: Where Are We?
   Kim HC, Lee HK. · · 2020 · cited 13× · PMID 32727077 · DOI 10.3390/vaccines8030420
6. 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