mRNA-1608 Vaccine for Genital Herpes

No longer recruiting at 33 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ModernaTX, Inc.

Must not be taking: Suppressive antivirals

Disqualifiers: Ocular HSV, Hepatitis B, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1608, for genital herpes. The goal is to determine if the vaccine safely and effectively boosts the body's defenses against the virus. Participants will receive varying doses to identify the optimal one, with a comparison to the existing vaccine, BEXSERO. Individuals with genital herpes for at least a year and frequent outbreaks may qualify for this trial. As a Phase 1/Phase 2 trial, the research aims to understand the vaccine's function in people and measure its effectiveness in a smaller group, offering participants a chance to be among the first to benefit from this new treatment.

Do I have to stop taking my current medications for the trial?

You will need to stop taking suppressive antiviral therapy from the start of the trial until it ends. You also need to avoid using episodic antiviral therapy during specific 28-day periods, but you can use it outside those times.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mRNA-1608 has promising results in early studies. These studies focus on understanding the vaccine's safety and effectiveness against herpes. While specific information on how people handle mRNA-1608 is not yet available, its current phase provides some insight into its safety. This trial is in the early stages, so researchers are still gathering detailed safety information.

For similar mRNA vaccines, such as those for COVID-19, common side effects have included mild and temporary reactions, like soreness at the injection site or fatigue. However, each vaccine is different, and mRNA-1608 is still being tested to determine its own safety profile. As more data becomes available, a clearer picture of how well people tolerate this vaccine will emerge. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mRNA-1608 vaccine for genital herpes because it uses cutting-edge mRNA technology, similar to what was used successfully in COVID-19 vaccines. Unlike current antiviral treatments like acyclovir or valacyclovir, which manage symptoms and outbreaks, mRNA-1608 aims to prevent infection by teaching the immune system to recognize and fight the herpes virus more effectively. This innovative approach could potentially reduce the frequency and severity of outbreaks, offering a proactive solution rather than a reactive one.

What evidence suggests that this trial's treatments could be effective for genital herpes?

This trial will evaluate the mRNA-1608 vaccine for genital herpes, with participants receiving different doses in separate arms. Research has shown that the mRNA-1608 vaccine could help fight genital herpes. Earlier studies found that a similar vaccine was 58% effective against HSV-1, a type of herpes virus, but not yet effective against HSV-2, which causes genital herpes. This suggests the mRNA-1608 vaccine might need further development to target the correct virus. The vaccine uses mRNA technology to teach the body how to fight the virus. Although still in early stages, this method has proven effective in other vaccines, offering hope for its potential. Early results are promising, but more research is needed to confirm its effectiveness specifically for genital herpes. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree not to use antiviral therapy during specific testing periods.

I have had 3 to 9 genital herpes outbreaks in the last year.

Willing to refrain from taking suppressive antiviral therapy from the Screening Visit until the end of the study

Exclusion Criteria

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

I have had genital herpes caused by HSV-1.

I have been vaccinated against meningitis B before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive 2 intramuscular injections of mRNA-1608 or BEXSERO at 0 and 2 months

2 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HSV-2 genital shedding and lesion rate assessments

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1608

Trial Overview 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.

How Is the Trial Designed?

Group I: mRNA-1608 Dose C Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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: BEXSERO Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

Genital herpes increases the risk of HIV transmission and poses significant health risks, especially to newborns, highlighting the urgent need for an effective vaccine.

Despite three phase 3 trials over the past 20 years using HSV-2 glycoproteins, none met their primary goals, though some showed partial success in delaying infection or protecting certain uninfected individuals, indicating that future vaccine development may benefit from improved animal model predictions and understanding immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccines to prevent genital herpes. Egan, K., Hook, LM., LaTourette, P., et al.[2021]

The Ac NFU1 (S-) MRC vaccine was tested in 60 at-risk subjects and showed no serious side effects, indicating a good safety profile for this potential herpes genitalis prevention method.

After 18 months of follow-up, none of the vaccinated participants contracted herpes genitalis, suggesting that the vaccine may be effective in providing long-term protection against the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation and immunogenicity of vaccine Ac NFU1 (S-) MRC towards the prevention of herpes genitalis. Skinner, GR., Woodman, CB., Hartley, CE., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11437400/

Toward the Eradication of Herpes Simplex Virus Three doses of the vaccine were 58% protective against culture-positive HSV-1 genital disease but not protective against HSV-2 infection or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06033261

A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) ... The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.

3. vax-before-travel.com vax-before-travel.com/vaccines/mrna-1608-herpes-vaccine

mRNA-1608 Herpes Vaccine According to GlobalData, Phase II drugs for Genital Herpes have a 30% phase transition success rate, indicating a benchmark for progressing into Phase III.

4. goodrx.com goodrx.com/conditions/herpes/herpes-vaccine-progress?srsltid=AfmBOopFVOfzaWKf0CZawzAu01-C3inqwgWCQ1y1LmP7V5j_c2Ifi5Mr

What's the Status on a Herpes Vaccine and Cure? Currently, the mRNA-1608 vaccine is being studied in a phase 1/2 clinical trial in adults ages 18 to 55 with a history of recurrent HSV-2 genital herpes.

5. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1608-P101

A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) ... A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608, an HSV-2 Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years ...

6. mdpi.com mdpi.com/2076-393X/13/9/908

The Path Towards Effective Long-Lasting Tissue-Targeted ... However, despite several efforts, a safe and effective genital herpes vaccine remains unavailable. There is currently no practical way to proactively prevent ...