What side effects are associated with this type of intervention?

Common treatments for herpes simplex virus (HSV) include antiviral medications such as acyclovir, valacyclovir, and famciclovir. These medications are generally well-tolerated but can cause side effects such as nausea, headache, and dizziness. In rare cases, more severe side effects like kidney issues and central nervous system effects (e.g., confusion, hallucinations) may occur. For immunotherapy treatments that stimulate the immune system to target HSV, potential side effects could include injection site reactions, flu-like symptoms (fever, chills, fatigue), and more serious immune-related adverse events such as inflammation or autoimmune reactions. It is important to discuss these potential side effects with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of herpes simplex virus (HSV) infections, including acyclovir, valacyclovir, and famciclovir. These medications work by inhibiting viral replication. However, there are no FDA-approved treatments specifically designed to stimulate the immune system to target and combat HSV, similar to the investigational HSV-targeted immunotherapy being studied. Current research is exploring immunotherapeutic approaches, but these are still in the experimental stages.

What other types of research exist?

Promising novel alternatives to HSV-targeted immunotherapy for herpes patients include: 1) CRISPR-Cas9 gene editing, which can target and disrupt the viral DNA within infected cells; 2) mRNA vaccines, similar to those developed for COVID-19, which can be designed to elicit a strong immune response against HSV; 3) Antiviral peptides that can inhibit viral entry or replication; and 4) Broad-spectrum antiviral drugs that enhance the host's immune response to various viral infections.

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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 months post-dose 2 (day 209) 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 below

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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, 12, 18 and 24 months after the last study intervention administration (day 29)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6, 12, 18 and 24 months after the last study intervention administration (day 29)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, 18 and 24 months after the last study intervention administration (day 29) for reporting.

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 more

Secondary study objectives

Duration of HSV-2 DNA shedding episodes in Part II of the study

HSV-2 shedding rate reduction from baseline to 12 months post-Dose 2 (Day 394) in Part II of the study

HSV-2 shedding rate reduction from baseline to 24 months post-Dose 2 (Day 759) in Part II of the study

+9 more

Trial 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.

0 / 10Eligibility criteria met

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.