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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
Must not have
Use of any investigational or non-registered product other than the study intervention during the period beginning as of the Screening visit, or planned use during the study period
Body mass index =<18 kg/m^2 or >=35 kg/m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 weeks post-dose 2 (day 71) compared to baseline (day -28 to day -1)
Summary
This trial tests a new therapy to help the immune system fight herpes. It involves healthy adults and those with recurrent genital herpes. The treatment aims to boost the body's ability to combat the virus.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't used any experimental drugs since my screening visit and won't use any during the study.
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My BMI is either below 18 or above 35.
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I do not have significant lung, heart, liver, hormone, or kidney issues.
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I have previously received a vaccine that contains HSV antigens.
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I plan to use medication that affects HSV shedding or genital lesions during the study.
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I have uncontrolled seizures or neurological disorders.
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I will be taking long-acting immune-modifying drugs during the study.
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I have had or currently have Guillain-Barré syndrome.
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I haven't taken any immune system altering drugs in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 weeks post-dose 2 (day 71) compared to baseline (day -28 to day -1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks post-dose 2 (day 71) compared to baseline (day -28 to day -1)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study
Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)
Percentage of participants reporting any serious adverse events (SAEs)
+5 moreSecondary study objectives
Duration of HSV-2 DNA shedding episodes in Part II of the study
HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study
Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the study
+5 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for herpes, such as acyclovir, valacyclovir, and famciclovir, work by inhibiting the replication of the herpes simplex virus (HSV), thereby reducing the severity and duration of outbreaks. Investigational HSV-targeted immunotherapy, on the other hand, aims to stimulate the patient's immune system to specifically target and combat HSV.
This approach could potentially offer more effective and long-lasting control of the virus. For herpes patients, these treatments are crucial as they help manage symptoms, reduce the frequency of outbreaks, and lower the risk of transmission to others.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,028 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,054 Total Patients Enrolled