NCT02114060

A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection

Completed Phase 2 Last updated 6 October 2017

What this trial tests

Phase 2 trial testing GEN-003 Vaccine (30μg of each antigen) in Genital Herpes Simplex Type 2 in 310 participants. Completed in 1 February 2016.

Timeline

1 July 2014

Primary endpoint
1 February 2016

1 February 2016

Quick facts

Lead sponsor	Genocea Biosciences, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	310
Start date	1 July 2014
Primary completion	1 February 2016
Estimated completion	1 February 2016
Sites	16 locations across United States

Drugs / interventions tested

• GEN-003 Vaccine (30μg of each antigen) — full drug profile →
• GEN-003 Vaccine (60μg of each antigen) — full drug profile →
• Matrix-M2 Adjuvant (25μg) — full drug profile →
• Matrix-M2 Adjuvant (50μg) — full drug profile →
• Matrix-M2 Adjuvant (75μg) — 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 proportion of days with detectable viral shedding
  Time frame: 6 weeks

Sponsor's own description

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.

Publications & conference data

8 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. Nanoengineering of vaccines using natural polysaccharides.
   Cordeiro AS, Alonso MJ, de la Fuente M. · · 2015 · cited 70× · PMID 26049133 · DOI 10.1016/j.biotechadv.2015.05.010
3. Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial.
   Van Wagoner N, Fife K, Leone PA, Bernstein DI, et al · · 2018 · cited 38× · PMID 29982727 · DOI 10.1093/infdis/jiy415
4. 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
5. Herpes Simplex Vaccines: Prospects of Live-attenuated HSV Vaccines to Combat Genital and Ocular infections.
   Stanfield B, Kousoulas KG. · · 2015 · cited 29× · PMID 27114893 · DOI 10.1007/s40588-015-0020-4
6. The Current State of Vaccine Development for Ocular HSV-1 Infection.
   Royer DJ, Cohen A, Carr D. · · 2015 · cited 21× · PMID 25983856 · DOI 10.1586/17469899.2015.1004315
7. Vaccines against Genital Herpes: Where Are We?
   Kim HC, Lee HK. · · 2020 · cited 13× · PMID 32727077 · DOI 10.3390/vaccines8030420
8. 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