Clinical trials: Herpes Simplex Type II
Herpes Genitalis
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection
This is a randomized, double-blind, double-dummy study of single dose HDIT101 versus Standard of Care Valaciclovir. HSV-2-positive patients with at least 4 anogenital herpes lesions in the last 12 months (or at least 2 herpes…
- Trial name
- MATCH-2 (NCT04165122)
- Testing
- HDIT101, Valaciclovir
- Where
- 8 sites in Germany
- Volunteers
- 122 people
- Sponsor
- Heidelberg ImmunoTherapeutics GmbH
Herpes Genitalis
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
- Trial name
- HSV-2 (NCT02837575)
- Testing
- VCL-HB01, Phosphate-buffered saline
- Where
- 15 sites in United States
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- Vical
Recurrent Genital Herpes Simplex Type 2
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in…
- Trial name
- NCT06385327
- Testing
- ABI-5366
- Where
- 15 sites in Australia, New Zealand
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Herpes Simplex Type 2
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before…
- Trial name
- NCT01687595
- Testing
- HerpV and QS-21
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Agenus Inc.
Genital Herpes
A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.
- Trial name
- NCT06033261
- Testing
- mRNA-1608, BEXSERO
- Where
- 23 sites in United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Recurrent Genital Herpes
UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals
A randomized, single-blind, dose-selected phase II trial to evaluate the safety, efficacy and PK of UB-621 in adults with recurrent genital HSV-2 infection
- Trial name
- NCT04714060
- Testing
- UB-621
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd
HSV-2 Infection, Herpes Simplex Virus Infection
NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
This study is designed to compare the performance of the NOWDx HSV-2 Test to a currently marketed device. The intent is to show the rapid test device is comparable to the currently marketed device.
- Trial name
- NCT04294030
- Testing
- Diagnostic Test: NOWDx HSV-2 Test
- Where
- 3 sites in United States
- Sponsor
- NOWDiagnostics, Inc.
Genital Herpes Simplex Type 2
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).
- Trial name
- NCT02030301
- Testing
- VCL-HB01, VCL-HM01, PBS
- Where
- 7 sites in United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Vical
HSV-2
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing.
- Trial name
- NCT00274300
- Testing
- pPJV7630 administered by PMED
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- PowderMed
Melanoma
OH2 Injection in Combination With HX008 for Melanoma.
This phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008, an anti-PD-1 antibody, in patients with Melanoma.
- Trial name
- NCT04616443
- Testing
- OH2 injection, HX008 injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Binhui Biopharmaceutical Co., Ltd.
Genital Herpes, HSV-2 Infection
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
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.
- Trial name
- NCT03146403
- Testing
- GEN-003, Matrix-M2, 0.9% normal saline
- Where
- 8 sites in United States
- Volunteers
- 33 people
- Sponsor
- Genocea Biosciences, Inc.
Genital Herpes Simplex Type 2
Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
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…
- Trial name
- NCT01667341
- Testing
- GEN-003 with Matrix M-2, GEN-003
- Where
- 7 sites in United States
- Volunteers
- 143 people
- Sponsor
- Genocea Biosciences, Inc.
Recurrent Genital Herpes Simplex Type 2
A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 in Part B in…
- Trial name
- NCT06698575
- Testing
- ABI-1179
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Genital Herpes Simplex Type 2
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2…
- Trial name
- NCT05432583
- Testing
- BNT163
- Where
- 6 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Genital Herpes
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621
To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.
- Trial name
- NCT03595995
- Testing
- UB-621
- Volunteers
- 80 people
- Sponsor
- United BioPharma
Genital Herpes Simplex Type 2
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
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.
- Trial name
- NCT02114060
- Testing
- GEN-003 Vaccine (30μg of each antigen), GEN-003 Vaccine (60μg of each antigen), Matrix-M2 Adjuvant (25μg)
- Where
- 16 sites in United States
- Volunteers
- 310 people
- Sponsor
- Genocea Biosciences, Inc.
Genital Herpes Simplex Type 2
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection.
- Trial name
- NCT02515175
- Testing
- Matrix-M2, GEN-003
- Where
- 8 sites in United States
- Volunteers
- 131 people
- Sponsor
- Genocea Biosciences, Inc.
Pancreatic Cancer
OH2 Oncolytic Viral Therapy in Pancreatic Cancer
This phase Ib/II study evaluates the safety and efficacy of OH2 in patients with locally advanced/metastatic pancreatic cancer who have failed first-line standard treatment.
- Trial name
- NCT04637698
- Testing
- OH2 injection
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Binhui Biopharmaceutical Co., Ltd.
HSV-2 Infection, Genital Herpes
The VIBLOK SAfety and perFormancE Trial
Genital herpes has a high prevalence in industrialized as well as developing countries. Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with…
- Trial name
- SAFE (NCT03080961)
- Testing
- VIBLOK barrier cream
- Where
- 3 sites in Netherlands
- Volunteers
- 82 people
- Sponsor
- CLJI Worldwide
Solid Tumor, Melanoma
OH2 Injection in Solid Tumors
This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma).
- Trial name
- NCT04386967
- Testing
- OH2 injection, Keytruda
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Binhui Biopharmaceutical Co., Ltd.