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

NCT05500053 — Completed, 68 participants, Rational Vaccines Inc

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RegistryNCT05500053
StatusCompleted
Study typeObservational
Enrollment68 (Actual)
SponsorRational Vaccines Inc (Industry)
ConditionsGenital Herpes, Patient Engagement
Datesstart 2022-08-03, primary completion 2022-12-31, completion 2022-12-31, first posted 2022-08-12, last updated 2023-01-18
Locations1 site in United Kingdom

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-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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+Outcome measures

Primary outcomes

  • Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease [day of questionnaire]: 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
  • Acceptance to patients of clinical trial procedures [day of questionnaire]: To determine using a questionnaire \- the acceptance to patients of clinical trial procedures
  • Interest in participation in genital herpes vaccine trials [day of questionnaire]: To determine using a questionnaire the number of patients interested in participation in genital herpes vaccine trials

+Eligibility

Sex: All, ages: 18 Years to 64 Years

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:

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

+Locations (1)

FacilityCityCountryStatus
Solent NHS TrustSouthampton, UKUnited Kingdom

+Investigators