Clinical trials: HSV-2
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
HSV-2
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects
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
- NCT00310271
- Testing
- pPJV7630 with pPJV2012 administered by PMED
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- PowderMed
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
Herpes Simplex
A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered…
- Trial name
- NCT04762511
- Testing
- Lower dose formulation of HSV vaccine (GSK4108771A), Low dose formulation of HSV vaccine (GSK4108771A), Medium dose formulation of HSV vaccine (GSK4108771A)
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Herpes Genitalis
An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.
The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe.
- Trial name
- NCT04950712
- Testing
- Blood sampling, Anogenital lesion swab collection
- Where
- 51 sites in United States, Finland and 4 more
- Volunteers
- 537 people
- Sponsor
- GlaxoSmithKline
Genital Herpes
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
The primary objectives of the study are: To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2).
- Trial name
- HSV15 (NCT04222985)
- Testing
- HSV 2 Formulation 1, HSV 2 Formulation 2, HSV 2 Formulation 3
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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.
Genital Herpes
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
- Trial name
- NCT01658826
- Testing
- AIC316, Valacyclovir
- Where
- 4 sites in United States
- Volunteers
- 91 people
- Sponsor
- AiCuris Anti-infective Cures AG
HSV-2
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
- Trial name
- NCT01047540
- Testing
- AIC316
- Where
- 6 sites in United States
- Volunteers
- 156 people
- Sponsor
- AiCuris Anti-infective Cures AG
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
Infections, Herpesviridae
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
- Trial name
- NCT00116844
- Testing
- Valaciclovir
- Where
- 17 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline