Clinical trials: HSV-2 Infection
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
Chronic Hepatitis C Infection
Herpes Simplex Type 1 Suppression in Hepatitis C
The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection.
- Trial name
- HSV1/HCV (NCT01580995)
- Testing
- Valacyclovir
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Bacterial Vaginosis
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
- Trial name
- MASH (NCT00464542)
- Testing
- Metronidazole
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
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
HIV, HIV Infections
Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding
The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily…
- Trial name
- NCT00803543
- Testing
- Valacyclovir
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
HIV Prevention
Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection
The purpose of the study is to assess the safety and effectiveness of intravaginal 1% tenofovir gel in preventing Human Immunodeficiency Virus (HIV-1) infection and Herpes Simplex Virus (HSV-2) infection in sexually active women.
- Trial name
- NCT01386294
- Testing
- Tenofovir gel
- Where
- 9 sites in South Africa
- Volunteers
- 2,059 people, healthy volunteers welcome
- Sponsor
- CONRAD
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
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
Herpes Simplex
Herpevac Neonatal Substudy
The purpose of this study to look at the antibodies (proteins from the body's infection fighting system) in the blood of babies delivered by women who are participants in the Herpevac Trial for Women, and who were vaccinated with…
- Trial name
- NCT00138320
- Where
- 5 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
HIV Infections
Stepping Stones Program for Preventing HIV Infection in Residents of Rural South African Communities
This study will evaluate the effectiveness of Stepping Stones, an HIV-prevention education program, versus a brief HIV-focused intervention, in improving sexual health and preventing HIV infection in young residents of rural…
- Trial name
- NCT00332878
- Testing
- Stepping Stones, stepping Stones short
- Where
- South Africa
- Volunteers
- 2,801 people, healthy volunteers welcome
- Sponsor
- Medical Research Council, South Africa
Herpes Simplex Type Two Infection, HIV Infections
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells…
- Trial name
- NCT00946556
- Testing
- Valacyclovir
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Toronto
Herpes Simplex II
VivaGel™ in Healthy Young Women
The purpose of this study is to test the safety and tolerability of a medication applied vaginally twice daily in females versus placebo (inactive substance).
- Trial name
- NCT00331032
- Testing
- 3% w/w SPL7013 Gel
- Where
- 2 sites in United States, Kenya
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Genital Herpes
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
The purposes of this study are: To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2); To assess the sensitivity and specificity of the commerical…
- Trial name
- NCT01112956
- Where
- 3 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Chronic Hepatitis C Infection
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes.
- Trial name
- NCT01453075
- Testing
- Valacyclovir
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development