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Virus Therapy
Targeted Immunotherapy for Genital Herpes
Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Man or woman aged 18 to 40 years, included, at the time of the first study intervention administration (PART I only)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-study intervention administration (day 1), day 29, day 57, day 209 and day 394, day 574, and day 759
Awards & highlights
Study Summary
This trial evaluates safety, immune response, and efficacy of a new HSV-targeted immunotherapy in healthy and recurrent genital herpes patients. Ages 18-60.
Who is the study for?
This trial is for healthy individuals aged 18-40 or those aged 18-60 with recurrent genital herpes. Participants must not be pregnant, HIV positive, or have a history of severe reactions to vaccines. They should not be on antiviral therapy and must agree to avoid pregnancy during the study.Check my eligibility
What is being tested?
The study tests various formulations of an investigational HSV-targeted immunotherapy (HSVTI) in two parts: one part in healthy participants and another in those with recurrent genital herpes, comparing them against placebo to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at the injection site, fever, fatigue, headache, muscle pain. Since this is a first-time-in-human study exact side effects are unknown but will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at pre-study intervention administration (day 1), day 29, day 57, day 209 and day 394, day 574, and day 759
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-study intervention administration (day 1), day 29, day 57, day 209 and day 394, day 574, and day 759
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study
+14 moreSecondary outcome measures
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study
Duration of HSV-2 DNA shedding episodes in Part II of the study
+17 moreTrial Design
13Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-adjuvanted HSV formulation 3 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29.
Group II: Non-adjuvanted HSV formulation 2 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29.
Group III: Non-adjuvanted HSV formulation 1 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29.
Group IV: HSVTI_F2 - Part II GroupExperimental Treatment1 Intervention
Participants enrolled in Part II of the study who receive 2 doses of the HSVTI_F2 selected from Part I of the study, one at Day 1 and one at Day 29.
Group V: HSVTI formulation (F) 1 - Part II GroupExperimental Treatment1 Intervention
Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI_F1 selected from Part I of the study, one at Day 1 and one at Day 29.
Group VI: HSV formulation 3 with adjuvant 2 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.
Group VII: HSV formulation 3 with adjuvant 1 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.
Group VIII: HSV formulation 2 with adjuvant 2 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.
Group IX: HSV formulation 2 with adjuvant 1 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.
Group X: HSV formulation 1 with adjuvant 2 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.
Group XI: HSV formulation 1 with adjuvant 1 - Part I GroupExperimental Treatment1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.
Group XII: Placebo - Part I GroupPlacebo Group1 Intervention
Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.
Group XIII: Placebo - Part II GroupPlacebo Group1 Intervention
Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,140 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,598 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I participate in this clinical investigation?
"To be eligible for this trail, individuals must have been diagnosed with herpes and fall within the ages of 18 to 60. Altogether, 332 participants may take part in the trial."
Answered by AI
Has the FDA sanctioned the use of HSVTI Formulation (F) 1 - Part II Group?
"Given the limited existing data on safety and efficacy, HSVTI formulation (F) 1 - Part II Group received a score of 1."
Answered by AI
Does the age restriction for this research study exceed 25 years of age?
"To be eligible for this trial, patients must have an age between 18 and 60. Additionally, 6 studies are available to individuals younger than 18 while 25 trials cater to those over 65 years old."
Answered by AI
How many participants can take part in this medical experiment?
"Yes, the online platform clinicaltrials.gov hosts information that shows this trial is recruiting participants now. It was first published on March 7th 2022 and updated September 22nd 2023; its current goal is to enrol 332 individuals from 31 medical sites."
Answered by AI
Are there opportunities for participants to join this research endeavor?
"Affirmative. Clinicaltrials.gov reports that this medical investigation, initially posted on March 7th 2022, is currently looking for participants to join their research team. In total 332 people are being sought after from 31 different venues of care."
Answered by AI
How many locations are participating in this experimental investigation?
"This clinical trial is admitting patients from 31 locations, including Phoenix, Wichita and Miami. It would be best to pick a nearby site in order to minimize commuting needs should you decide to join the study."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
A cure for HSV_2. Tenho crises recorrente. Clinical trials open in Australia.
PatientReceived 1 prior treatment
I've had a blister that comes and goes for the last two years. I'm married 23 years. My husband admitted to having relations with another woman and we've been working through that. Two years ago he had a spot in his public hair area that the doctor treated for cellulitis then it came back and she thought it could be herpes. She didn't have any tests at the time. He has healed but I keep getting a blister on my ***** since the first time he had what was belived to be cellulitis. I haven't been confirmed yet, but given everything I've read about herpes I believe this is what I have. I currently have a blister now. If you're able to test for it I will allow you to do so to confirm that this is in fact herpes 2.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Do I have to have a positive confirmation of having herpes 2 already or can you test me for it?
PatientReceived no prior treatments
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