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.

A Descriptive, Prospective, Multi-country, Multicentre Study to Assess Performance of Genital Herpes Simplex Virus-2 (HSV-2) Related Disease Endpoints Based on Patient-reported Health Outcomes, Self-swabbing Collected Via Decentralised Approach 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.

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.

Study Overview

• Status: Completed
• Conditions: Herpes Genitalis
• Intervention / Treatment: Procedure: Blood sampling; Procedure: Anogenital lesion swab collection

• Study Type: Observational
• Enrollment (Actual): 537

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00250
    • GSK Investigational Site
  • Oulu, Finland, 90100
    • GSK Investigational Site
  • Tampere, Finland, FI-33100
    • GSK Investigational Site
• France
  • Montpellier cedex, France, 34295
    • GSK Investigational Site
  • Nantes, France, 44093
    • GSK Investigational Site
  • Paris, France, 75010
    • GSK Investigational Site
  • Paris cedex 14, France, 75679
    • GSK Investigational Site
  • Pierre BEnite, France, 69495
    • GSK Investigational Site
  • Saint-Etienne, France, 42055
    • GSK Investigational Site
  • Toulouse, France, 31059
    • GSK Investigational Site
• Italy
  • Bari, Italy, 70120
    • GSK Investigational Site
  • Milano, Italy, 20127
    • GSK Investigational Site
  • Palermo, Italy, 90127
    • GSK Investigational Site
  • Roma, Italy, 00144
    • GSK Investigational Site
• Spain
  • Alcorcon, Spain, 28922
    • GSK Investigational Site
  • Barcelona, Spain, 08001
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28010
    • GSK Investigational Site
  • Marbella, Spain, 29600
    • GSK Investigational Site
  • Oviedo, Spain, 33011
    • GSK Investigational Site
  • Valencia, Spain, 46026
    • GSK Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B4 6DH
    • GSK Investigational Site
  • Brighton, United Kingdom, BN2 1ES
    • GSK Investigational Site
  • Leeds Yorkshire, United Kingdom, LS2 8NG
    • GSK Investigational Site
  • Liverpool, United Kingdom, L7 8YE
    • GSK Investigational Site
  • London, United Kingdom, WC1E 6JB
    • GSK Investigational Site
  • London, United Kingdom, SE1 0UN
    • GSK Investigational Site
  • Southampton, United Kingdom, SO14 0YG
    • GSK Investigational Site
• United States
  • California
    • Long Beach, California, United States, 90806
      • GSK Investigational Site
    • Los Angeles, California, United States, 90027
      • GSK Investigational Site
    • San Francisco, California, United States, 94102
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33126
      • GSK Investigational Site
    • Miami, Florida, United States, 33134
      • GSK Investigational Site
    • Miami, Florida, United States, 33015
      • GSK Investigational Site
    • Plantation, Florida, United States, 33317
      • GSK Investigational Site
  • Georgia
    • Marietta, Georgia, United States, 30067
      • GSK Investigational Site
    • Smyrna, Georgia, United States, 30082
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63108
      • GSK Investigational Site
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • GSK Investigational Site
    • Newark, New Jersey, United States, 07103
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38129
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77054
      • GSK Investigational Site
    • Houston, Texas, United States, 77339
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23235
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited in specific community settings in the United States and in Europe. Screening logs will be used to assess participation rate.

Description

Inclusion Criteria:

• Man or woman ≥18 years old.
• Written informed consent obtained from the patient prior to performance of any study-specific procedure.
• History of at least one episode of HSV-2 genital herpes lesions in the 12 months preceding the screening, and seropositive for HSV-2 as determined by Western blot OR PCR-positive for HSV-2 (newly diagnosed patients).
• Patients who are medically stable in the opinion of the investigator.
• Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular telephone calls/study site visits/home visits/self-completion of questionnaires, self-swabbing).
• Seronegative for HIV, as determined by laboratory testing. Patients documented to be positive to HIV will not be eligible for study participation

Exclusion Criteria:

• Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
• Immunocompromised patients, as per medical history and investigator judgement.
• Other genital tract disorders or sexually transmitted diseases that may interfere with the assessment of the study (as per investigator's judgement).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Overall Study Group; Patients aged 18 years old or above, with HSV-2 genital herpes, who are recruited in specific community settings in the United States and in Europe.	Procedure: Blood sampling; Blood samples for HSV-2 testing and for HIV test are collected from patients at screening visit (first visit).; Procedure: Anogenital lesion swab collection; Anogenital lesion swab of all lesions are collected at screening visit (only for newly infected HSV-2 patients) and at first genital HSV-2 recurrence during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences	Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test.	During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
Duration of PCR-confirmed genital HSV-2 recurrences	Duration of a recurrence is defined as number of consecutive days with the presence of HSV-2 lesion(s) and associated prodromal symptoms and/or erythema (skin redness).	During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire	From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of change (PGI-C) questionnaire	From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes symptoms checklist (HSC) questionnaire	From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes outbreak impact (HOIQ) questionnaire	From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HSC questionnaire	From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HOIQ questionnaire	From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months)
Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by EuroQoL-5 dimension (EQ-5D) health questionnaire	At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence
Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by Recurrent genital herpes quality-of-life (RGHQoL) questionnaire	At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by short form-12 questionnaire	At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24
Number of self-swabs collected during genital HSV-2 recurrences throughout the study period	Throughout the study period (from Day 1 up to Month 24)
HSV-2 PCR self-swab results	At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
HSV-2 PCR investigator swab results	At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)
Number of patients reporting genital HSV-2 recurrences by using eDiary	Throughout the study period (from Day 1 up to Month 24)
Number of patients reporting genital HSV-2 recurrence during the 3 monthly calls with the investigator	Throughout the study period (from Day 1 up to Month 24)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Herpes Simplex Virus-2; HSV-2 genital herpes; HSV-2 recurrence
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Virus Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases; Skin Diseases, Infectious; Herpesviridae Infections; Skin Diseases, Viral; Herpes Simplex; Herpes Genitalis
• Other Study ID Numbers: 214523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No