Genital HerpesNCT05500053
A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
An observational study of Genital Herpes and Patient Engagement, run by Rational Vaccines Inc at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Genital Herpes, Patient Engagement
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with recurrent symptomatic of genital herpes
Who may be able to join
- 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
Who cannot join
- Subjects who do not meet the inclusion criteria for the study
- Subjects who are unable to provide legally effective informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Herpes Genitalis, Patient Participation
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day of questionnaire
Acceptance to patients of clinical trial procedures
To determine using a questionnaire
- the acceptance to patients of clinical trial procedures
Measured: 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
Measured: day of questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start3 Aug 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rational Vaccines Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajul Patel, Principal investigator, Solent NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500053
- Sponsor's protocol ID
- RVx-001-PSS
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
- ClinicalTrials.gov ID
- NCT05500053
- Acronym / sponsor ID
- RVx-001-PSS
- Conditions
- Genital Herpes, Patient Engagement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Rational Vaccines IncIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with recurrent symptomatic of genital herpes
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects who do not meet the inclusion criteria for the study
- Subjects who are unable to provide legally effective informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease
Time frame: 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
Time frame: day of questionnaire
To determine using a questionnaire - the acceptance to patients of clinical trial procedures
Interest in participation in genital herpes vaccine trials
Time frame: day of questionnaire
To determine using a questionnaire the number of patients interested in participation in genital herpes vaccine trials
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajul Patel principal investigator
Solent NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Herpes and Patient Engagement, run by Rational Vaccines Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease (time frame: day of questionnaire). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.