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CompletedNCT05500053Updated Jan 18, 2023

A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease

An observational study in Genital Herpes and Patient Engagement, sponsored by Rational Vaccines Inc. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Rational Vaccines Inc · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
68
Ages
18 Years to 64 Years
Sex
All
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Study summary

Determine the baseline characteristics of patients who have recurrent symptomatic genital herpetic disease Determine the acceptance to patients of clinical trial procedures Determine interest in participation in genital herpes vaccine trials

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Conditions studied

  • Genital Herpes
  • Patient Engagement

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03

In context

Herpes Genitalis

70 studies on the registry are indexed under Herpes Genitalis; 3 are open to participants now.

This study's enrollment of 68 is below the median of 300 across 14 observational studies indexed under Herpes Genitalis.

Browse Herpes Genitalis studies →

Lead sponsor

This is the only study on the registry with Rational Vaccines Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with recurrent symptomatic of genital herpes

Inclusion criteria

  • Able to understand and willing to sign the informed consent document.
  • Patient confirmation of a diagnosis of HSV-2 infection at least 2 years prior to inclusion. Laboratory confirmation is not required.
  • Symptomatic recurrent genital herpetic disease for >2 years supported by compatible clinical history

Exclusion criteria

Exclusion Criteria:

  • Subjects who do not meet the inclusion criteria for the study
  • Subjects who are unable to provide legally effective informed consent
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Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
68 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease

    To determine using a questionnaire * number of annual outbreaks of patients who have recurrent symptomatic genital herpetic disease * number of patients using suppressiv antiviral therapy * number of patients using antivirals for the treatment of outbreaks * number of patients using symptomatic therapy other than antivirals

    Time frame: day of questionnaire

  2. Acceptance to patients of clinical trial procedures

    To determine using a questionnaire - the acceptance to patients of clinical trial procedures

    Time frame: day of questionnaire

  3. Interest in participation in genital herpes vaccine trials

    To determine using a questionnaire the number of patients interested in participation in genital herpes vaccine trials

    Time frame: day of questionnaire

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Study locations

1 site
  • Solent NHS Trust
    Southampton, UK SO10 8BR, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05500053
Lead sponsor
Rational Vaccines Inc
Responsible party
Sponsor
First posted
Aug 12, 2022
Start date
Aug 3, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jan 18, 2023

Study contacts

Rajul Patel
principal investigator · Solent NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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