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

Sponsor
Rational Vaccines Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05500053
Collaborator
(none)
200
Enrollment
1
Location
5
Anticipated Duration (Months)
40.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    Official Title:
    A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
    Actual Study Start Date :
    Aug 3, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Acceptance to patients of clinical trial procedures [day of questionnaire]

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

    3. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Solent NHS Trust Southampton UK United Kingdom SO10 8BR

    Sponsors and Collaborators

    • Rational Vaccines Inc

    Investigators

    • Principal Investigator: Rajul Patel, Solent NHS Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rational Vaccines Inc
    ClinicalTrials.gov Identifier:
    NCT05500053
    Other Study ID Numbers:
    • RVx-001-PSS
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Herpes Genitalis

    Study Results

    No Results Posted as of Aug 12, 2022