mRNA-1608 Vaccine for Genital Herpes

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

365 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the mRNA-1608 treatment for genital herpes?

Research shows that a similar mRNA vaccine using nucleoside-modified mRNA in lipid nanoparticles provided better protection against genital herpes in animal models compared to other vaccine types. This suggests that the mRNA-1608 treatment could be effective in preventing genital herpes. ^{1 2 3 4 5}

How is the mRNA-1608 treatment for genital herpes different from other treatments?

The mRNA-1608 treatment is unique because it uses mRNA technology, which has shown promise in creating strong and long-lasting immune responses. Unlike traditional vaccines, this approach can be rapidly developed and scaled up, potentially offering better protection against genital herpes by targeting both HSV-1 and HSV-2. ^{1 3 4 5 6}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Protection against herpes simplex virus type 2 infection in a neonatal murine model using a trivalent nucleoside-modified mRNA in lipid nanoparticle vaccine. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Status of prophylactic and therapeutic genital herpes vaccines. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Vaccines to prevent genital herpes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Preparation and immunogenicity of vaccine Ac NFU1 (S-) MRC towards the prevention of herpes genitalis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

An mRNA vaccine to prevent genital herpes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Trivalent nucleoside-modified mRNA vaccine yields durable memory B cell protection against genital herpes in preclinical models. [2023]