What side effects are associated with this type of intervention?

Common treatments for genital herpes, such as antiviral medications (acyclovir, valacyclovir, and famciclovir), generally have mild and infrequent side effects, including headaches, nausea, and fatigue. The mRNA-1608 vaccine, which uses messenger RNA technology to stimulate an immune response, is still under study, but similar mRNA vaccines typically cause side effects like injection site reactions, fever, and muscle pain.

What prior FDA approvals exist?

The FDA has approved several antiviral medications for the treatment of genital herpes, including acyclovir, valacyclovir, and famciclovir. These drugs work by inhibiting viral replication, thereby reducing the severity and frequency of outbreaks. While these treatments are effective, they do not cure the infection. Currently, there are no FDA-approved vaccines for genital herpes that use mRNA technology similar to the mRNA-1608 vaccine being studied. The mRNA-1608 vaccine represents a novel approach, aiming to stimulate an immune response to provide therapeutic benefits for individuals with recurrent HSV-2 genital herpes.

What other types of research exist?

Promising, novel alternatives to the mRNA-1608 vaccine for genital herpes patients include: 1) Topical cidofovir, which has shown efficacy in clearing viral lesions in other conditions like vulvar intraepithelial neoplasia. 2) Investigational vaccines designed to elicit a cellular immune response, which may offer a different mechanism of action compared to mRNA vaccines. 3) Antiviral agents such as favipiravir and remdesivir, which have shown efficacy in treating other viral infections and could potentially be adapted for herpes treatment.

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Cancer Vaccine

mRNA-1608 Vaccine for Genital Herpes

Phase 1 & 2

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Seropositive for HSV-2 as determined by Western Blot

Be between 18 and 65 years old

Must not have

History of genital HSV-1 infection

History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1 or 2 (HIV-1, HIV-2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day -27 to day 1), day 197 to day 225

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine called mRNA-1608 in people who frequently get genital herpes. The vaccine aims to help their immune system recognize and fight the herpes virus, which could reduce how often and how severely they get outbreaks.

Who is the study for?

Adults aged 18-55 with recurrent genital herpes (HSV-2) are eligible for this trial. They must have had at least 3 but no more than 9 flare-ups in the past year, or before starting suppressive therapy if they're on it. Participants can't join if they've had certain other vaccines recently, a history of HSV-1, hepatitis B/C, HIV, ocular HSV infection, severe allergies to vaccine components or anaphylaxis after mRNA vaccines.

What is being tested?

The study is testing mRNA-1608 as a potential vaccine for genital herpes against BEXSERO (a meningitis B vaccine). The goal is to see how safe mRNA-1608 is and how well it works to stimulate the body's defenses against herpes.

What are the potential side effects?

Potential side effects may include typical reactions seen with vaccinations such as pain at injection site, fatigue, headache and possibly fever. Since this is investigational research specific side effects of mRNA-1608 are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tested positive for HSV-2.

Exclusion Criteria

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

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I have had genital herpes caused by HSV-1.

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I have a history of hepatitis B, C, or HIV.

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I have been vaccinated against meningitis B before.

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I have been vaccinated with a vaccine that includes HSV antigens.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day -27 to day 1), day 197 to day 225

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day -27 to day 1), day 197 to day 225

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day -27 to day 1), day 197 to day 225 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)

Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 Deoxyribonucleic acid [DNA] Positive Anogenital Swabs)

Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Proportion of Days With Lesions Present)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: mRNA-1608 Dose CExperimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1608 at Dose Level C, each dose administered at 0 and 2 months (Day 1 and Day 57).

Group II: mRNA-1608 Dose BExperimental Treatment1 Intervention

Participants will receive 2 IM injections of mRNA-1608 at Dose Level B, each dose administered at 0 and 2 months (Day 1 and Day 57).

Group III: mRNA-1608 Dose AExperimental Treatment1 Intervention

Participants will receive 2 intramuscular (IM) injections of mRNA-1608 at Dose Level A, each dose administered at 0 and 2 months (Day 1 and Day 57).

Group IV: BEXSEROExperimental Treatment1 Intervention

Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57).

0 / 5Eligibility 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 genital herpes include antiviral medications like acyclovir, valacyclovir, and famciclovir, which work by inhibiting viral replication, thereby reducing the severity and frequency of outbreaks. The mRNA-1608 vaccine, currently under study, uses messenger RNA technology to stimulate the body's immune system to recognize and fight the herpes simplex virus (HSV-2). This approach aims to provide a more effective and long-lasting immune response compared to traditional antiviral treatments. For genital herpes patients, this matters because it could potentially reduce the frequency of outbreaks, lower the risk of transmission, and improve overall quality of life.

Intranasal nanoemulsion-adjuvanted HSV-2 subunit vaccine is effective as a prophylactic and therapeutic vaccine using the guinea pig model of genital herpes.The possible of immunotherapy for COVID-19: A systematic review.A Workflow for In Vivo Evaluation of Candidate Inputs and Outputs for Cell Classifier Gene Circuits.