NCT01667341

A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection

Completed Phase 1/Phase 2 Last updated 30 May 2018

What this trial tests

Phase 1/Phase 2 trial testing GEN-003 with Matrix M-2 in Genital Herpes Simplex Type 2 in 143 participants. Completed in 9 May 2014.

Timeline

1 July 2012

Primary endpoint
9 May 2014

9 May 2014

Quick facts

Lead sponsor	Genocea Biosciences, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	143
Start date	1 July 2012
Primary completion	9 May 2014
Estimated completion	9 May 2014
Sites	7 locations across United States

Drugs / interventions tested

• GEN-003 with Matrix M-2 — 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.

• Number of patients with adverse events as a measure of safety and tolerability
  Time frame: 57 Weeks

Sponsor's own description

Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:

1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)
2. GEN-003: Antigens alone
3. Placebo (DPBS diluent)

Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows:

* 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
* 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
* 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
* Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)

Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.

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. Current status and prospects for development of an HSV vaccine.
   Johnston C, Koelle DM, Wald A. · · 2014 · cited 59× · PMID 24016811 · DOI 10.1016/j.vaccine.2013.08.066
3. Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial.
   Bernstein DI, Wald A, Warren T, Fife K, et al · · 2017 · cited 57× · PMID 28329211 · DOI 10.1093/infdis/jix004
4. The challenges and opportunities for the development of a T-cell epitope-based herpes simplex vaccine.
   Kuo T, Wang C, Badakhshan T, Chilukuri S, et al · · 2014 · cited 47× · PMID 25446827 · DOI 10.1016/j.vaccine.2014.10.002
5. Distribution and effects of amino acid changes in drug-resistant α and β herpesviruses DNA polymerase.
   Topalis D, Gillemot S, Snoeck R, Andrei G. · · 2016 · cited 32× · PMID 27694307 · DOI 10.1093/nar/gkw875
6. 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
7. 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
8. Vaccines against Genital Herpes: Where Are We?
   Kim HC, Lee HK. · · 2020 · cited 13× · PMID 32727077 · DOI 10.3390/vaccines8030420