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

NCT05500053 | Completed

• 1 other identifier: RVx-001-PSS
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Genital Herpes; Patient Engagement

Outcome Measures

Primary Outcomes (3)

• 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

  day of questionnaire

• Acceptance to patients of clinical trial procedures

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

  day of questionnaire

• 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

  day of questionnaire

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with recurrent symptomatic of genital herpes

You may qualify if:

• Able to understand and willing to sign the informed consent document.
• Symptomatic recurrent genital herpetic disease for \>2 years supported by compatible clinical history

You may not qualify if:

• Subjects who are unable to provide legally effective informed consent

Sponsors & Collaborators

• Rational Vaccines Inc: lead

Study Sites (1)

Solent NHS Trust

Southampton, UK, SO10 8BR, United Kingdom

Location

MeSH Terms

Conditions

Herpes Genitalis; Patient Participation

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rajul Patel

  Solent NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: August 3, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

GB (1)