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

Completed

• Conditions: Genital Herpes; Patient Engagement

• Registration Number: NCT05500053
• Lead Sponsor: Rational Vaccines Inc

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-03
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Solent NHS Trust; 🇬🇧 Southampton, UK, United Kingdom