View clinical trials related to Herpes Simplex.
Filter by:The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study will be conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.
This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
This study seeks to identify and test host RNA expression profiles in context to protein biomarkers in dried blood spot samples as novel diagnostic markers of neonatal herpes simplex virus infection and to improve the understanding of the pathogenesis of the disease.
The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
- Herpesvirus infections may be severe in immunocompromised patients, with a high risk of complications and mortality. - Recipients of hematopoietic stem cell transplant (HSCT) or patients receiving high-intensity chemotherapy for hematological malignancies are the most vulnerable individuals. - Although the worldwide prevalence of herpes simplex virus 1 (HSV-1) and varicella-zoster virus (VZV), antiviral prophylaxis in seropositive HSCT recipients has significantly reduced the rate of infection. - Acyclovir (ACV) is the first-choice drug for the prophylaxis or the therapy of that kind of infection. - Since the beginning, ACV has demonstrated to be characterized by a large interpatient variability, especially in children. - Therefore, therapeutic drug monitoring and pharmacokinetic studies may help in optimizing drug in children with malignancies.
Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs. Herpes labialis is caused by a virus called the herpes simplex virus (HSV). The infection is spread when a person comes into direct contact with someone else who has the infection. Once a person becomes infected with HSV, the virus multiplies and spreads, which can cause redness and blistering on the mouth and lip. The blisters crust over and heal. Once healed, the virus is said to go into an "inactive" phase. This means the virus does not cause any symptoms, but still remains in the body. HSV can then become "active" again. This means causing cold sore lesions to reappear. HSV can become active in different ways. Some of these include when a person has a fever, comes into contact with strong sunlight or has a condition that lowers one's immune system It can also happen during a woman's menstrual cycle, also called a period. In this study, the researchers want to gather additional data on acyclovir 50 mg tablet, an available treatment for herpes labialis. It is a buccal tablet that sticks to the gum inside the mouth and directly treats the infected area to help stop the HSV from multiplying and spreading. In this study, the researchers want to compare the efficacy of acyclovir 50 mg buccal tablets versus placebo in the treatment of herpes labialis. A placebo is a treatment that looks like the study medicine but does not have any medicine in it. Study participants will include those who have had at least 4 episodes of herpes labialis within the past 12 months prior to joining the study. To compare the study treatments, the researchers will measure the "duration of episode" (DOE) for each participant. DOE is amount of time it takes for symptoms to disappear and for herpes labialis lesions to heal after taking the study treatment. A doctor will look at the participants' symptom scores and facial images to determine the DOE. Assessments will be done over a period of 14 days. The participants in this study will apply either acyclovir 50mg buccal tablet or the placebo as a tablet to the upper gum 1 time. There will be a 2 week treatment phase and a 12 month follow up phase. The participants in this study will not be required to visit the study site. Instead, the participants will have virtual meetings with the study doctors from their homes using the internet. During the treatment phase, there will be 2 meetings. Throughout the follow up phase, the doctors will call the participants 4 times. Each participant will be in the study for about 20 months. During the treatment phase of the study, the participants will: - take their blood pressure and pulse - check their mouth health through a questionnaire - take pictures of their face and herpes labialis symptoms During the whole study the participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Vaccines are used to prevent infectious diseases worldwide. Unfortunately, many vaccines, like the flu vaccine, are less effective in older adults. This single-centre open label partially randomised, partially placebo-controlled trial evaluates the differences in immune response between young and older adults after vaccination with a quadrivalent inactivated influenza vaccine and an adjuvanted herpes zoster vaccination. Exploring the underlying mechanisms between the differences in immunogenicity can provide important information for future vaccine development.
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. More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.
This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 20 subjects with documented herpes labialis. Patients will be treated with the study drug, EDTA Eye Drops or the active comparator of Abreva. Potential subjects will be assessed during a screening visit that must take place no greater than 2 weeks prior to the Day 1 (Baseline) visit. During the screening period, subjects that meet all other entry criteria will undergo UV susceptibility testing to determine their individual MED (minimal erythemal dose). UV susceptibility testing takes place over two days with exposure to UV light on specified regions on the subject's back followed by an assessment of the exposed areas 24 hours later to identify the MED. Subjects who have a measurable MED will be allowed to enroll in the study. Each subject will be randomly assigned in a 1:1 ratio to receive either EED or Comparator. Patients who express a cold sore will track the lesion with a diary card to rate their pain levels, and any unusual symptoms at Day 1, Day 3, Day 5, Day 7, and Day 10. Patients may also take photographs of the lesion throughout the study.
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 intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 18-40 years.