NCT02300142

Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2

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 37 participants. Completed in 1 June 2016.

Timeline

1 January 2015

Primary endpoint
1 June 2016

1 June 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	37
Start date	1 January 2015
Primary completion	1 June 2016
Estimated completion	1 June 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 →

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.

• Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
  Time frame: 53 weeks

Sponsor's own description

This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.

Objectives:

* To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:

* Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)
* 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 follow-up period
* Antiviral use.
* To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.

Publications & conference data

5 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. 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
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