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.
Trial overview
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)
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)
Participation criteria
- 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.
- 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
Man or woman ≥18 years old.
- 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).
Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.