Active clinical trials for "Herpes Genitalis"

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.

This exploratory trial will have two parts. Part A will focus on the safety evaluations, but 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 a BNT163 dose selected based on Part A data and also enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses than could be assessed in Part A.

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.

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.

To evaluate the efficacy of repeat-dose UB-621 for the recurrent genital HSV-2 infection To evaluate the safety and tolerance of repeat-dose UB-621 for the recurrent HSV-2 infection To evaluate the pharmacokinetics of repeat-dose UB-621 in RGH patients

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.

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

Despite sex education in schools and prevention campaigns concerning sexually transmitted infections, genital herpes remains frequent infection. In 2016, according to the World Health Organization, more than 490 million people worldwide were living with a 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. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.

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