48 Clinical Trials for Various Conditions
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.
Genital Herpes
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 genital herpes. Part A will focus on the safety evaluations, and in addition, vaccine-induced immune responses (specifically neutralizing antibodies) will also be analyzed to assess if there is a dose-response. Part B of the trial will expand the safety characterization for two dose levels of BNT163 selected based on Part A data and will also enable a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and immune responses to BNT163. Part C will evaluate safety and immunogenicity of BNT163 compared to a placebo in a three-dose regimen in subjects with a history of HSV-2 recurrent genital herpes.
Genital Herpes Simplex Type 2
Severe Maternal Morbidity (SMM) has been associated with maternal mortality, fetal risk, and long-term maternal risk. African American (AA) women are at consistently higher risk than White women. However, factors contributing to these racial disparities are largely unknown and commonly known factors have not been able to explain them, so strategies to reduce them are absent. CDC reports that the rate of GHSV infection is 4 times higher in AA than White women. Studies have shown that pregnant women with genital herpes simplex virus (GHSV) infection are at higher risk of SMM and that treating women with GHSV using existing anti-herpes medications could reduce SMM risk. To address the question of racial disparities in SMM and examine the comparative effectiveness of treating women with GHSV infection to reduce the risk of SMM, the investigators are conducting a large cohort study with a two-stage design, combining an EMR-based cohort (Stage I) with a sub-cohort interview (Stage II) to examine the impact of confounders not available from EMR data. Based on status of GHSV and treatment, 4 cohorts of women will be established: (1) those with GHSV infection receiving treatment early in pregnancy; (2) those with GHSV infection receiving treatment later in pregnancy; (3) those with GHSV infection untreated during pregnancy; and (4) those without GHSV. Given that racial disparities in SMM present serious challenges, the study will provide much needed data to address the effectiveness of treating GHSV on reducing racial disparities in SMM.
Genital Herpes Simplex, Maternal Morbidity, Racial Disparities
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.
Herpes Simplex
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.
Herpes Genitalis
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). * To evaluate the efficacy of the investigational vaccine regimens with respect to: * the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule * the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule The secondary objectives of the study are: * To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group
Genital Herpes
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. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
Genital Herpes, HSV-2 Infection
Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births with annual medical costs of more than $26 billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is considered a top research priority. Recent research has shown genital herpes infection (HSV) is associated with increased risks of PTD and LBW. More importantly, treating this infection, including infection with no symptoms, using readily available antiviral medications can be effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a lack of demonstrated benefit of treatment and (b) general hesitance to use medications during pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by anti-herpes medications has significantly changed current treatment paradigms among pregnant women. This evidence also provides new hope that effectively treating HSV infection among pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic disparities in these risks due to high rates of the infection in minority groups. To further examine the effectiveness of treating HSV in pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a prospective cohort study with a two-stage design combining the large pregnant women population (N=90,000) in Stage I identified through Kaiser Permanente Northern California (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed information on additional factors that might muddle our understanding of this issue. This study will address the following: (1) Does treating HSV infection in pregnant women reduce the risk of PTD or LBW? (2) Does timing of the treatment during pregnancy influence treatment effectiveness? (3) Do other factors influence treatment effectiveness? and (4) Does HSV infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared to no infection? Answers to these questions will be valuable to pregnant women and clinicians, and directly address their concerns when making treatment decisions
HSV-2 Infection, PreTerm Birth, Pregnancy Complications
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).
Genital Herpes Simplex Type 2
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 and after treatment.
Herpes Simplex Type 2
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.
Genital Herpes
The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir will reduce genital HSV shedding compared to placebo.
Herpes Simplex Type II
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
HSV-2
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
Herpes Genitalis
This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
Genital Herpes
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
Genital Herpes
Brief summary: The current management guidelines recommended by ACOG rely on history as a screening method to determine pregnant women who are at risk for transmitting herpes to their newborn. History fails completely in identifying the women most at risk of transmitting herpes to their newborn - the seronegative woman who acquires a primary infection from her partner during pregnancy. Despite recent advances, both pregnant women and newborns continue to be at risk of acquiring herpes infection. Genital herpes infections are epidemic in the United States. In the early 1990's, 25% of women in the US were seropositive for the HSV-2 antibody. These numbers are likely higher now. The incidence of neonatal herpes in the US cannot be accurately estimated since it is not a reportable disease. However, in some areas of the US, the incidence is 1 in 3,200 live births which would translate to an incidence of approximately three infants a day in the US . In other areas of the US, the incidence is even higher, approaching 1 in 1,500 liveborns. This protocol examines patient acceptance of HSV-1 and HSV-2 type specific serologic testing and assesses patient counseling tools. In addition, seroprevalence of HSV-2 in pregnant patients will be collected and evaluated.
Pregnancy
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. The study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks
HSV-2
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.
Herpes Genitalis
This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count \<100 cells/mm3.
Herpes Genitalis
Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM). Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.
HIV Infections, HIV Seronegativity, Herpes Genitalis
The purpose of this study is to provide biomedical and behavioral information that is necessary for planning and starting HIV prevention trials in Lima, Peru. The occurrence of HIV is high among men who have sex with men (MSM) in Lima, Peru, and bacterial sexually transmitted diseases (STDs) and HSV-2 (genital herpes) are very prevalent in HIV-positive and -negative MSM there. Methods to reduce both HIV and STDs are urgently needed among MSM in Peru. The information gained from this study is very important for future HIV prevention and vaccine trials that will take place in Peru.
HIV Infections, Herpes Genitalis, HIV Seronegativity, Syphilis
The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
Herpes Simplex, HIV Infections, Herpes Genitalis
This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.
Genital Herpes Simplex Type 2
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).
Herpes Genitalis
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Genital Herpes Simplex Type 2
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine * Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period * Antiviral use. * To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
Genital Herpes Simplex Type 2
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. Secondary objectives of the study include: * Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. * Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence, * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine, * Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods. * Evaluation of cellular and humoral responses to GEN-003 antigens. Additional objectives include: * Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above. * Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
Genital Herpes Simplex Type 2
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.
Genital Herpes Simplex Type 2
On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications. The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in persons with genital herpes. The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control. Involvement in the study will last 11-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.
Genital Herpes