Last updated: 03/07/2025 12:10:30

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.

GSK study ID
214523
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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.
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences

Timeframe: 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

Timeframe: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)

Secondary outcomes:

Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Throughout the study period (from Day 1 up to Month 24)

HSV-2 PCR self-swab results

Timeframe: At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months)

HSV-2 PCR investigator swab results

Timeframe: 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

Timeframe: 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

Timeframe: Throughout the study period (from Day 1 up to Month 24)

Interventions:
Procedure/surgery: Blood sampling
Procedure/surgery: Anogenital lesion swab collection
Enrollment:
537
Observational study model:
Other
Primary completion date:
2024-14-03
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Herpes Genitalis
Product
SB208141
Collaborators
Not applicable
Study date(s)
June 2021 to March 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Man or woman ≥18 years old.
  • Written informed consent obtained from the patient prior to performance of any study-specific procedure.
  • Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
  • Immunocompromised patients, as per medical history and investigator judgement.

Trial location(s)

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

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Finalized
Actual primary completion date
2024-14-03
Actual study completion date
2024-14-03

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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