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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day -27 to day 1), day 197 to day 225
Awards & highlights

Study Summary

This trial tests a vaccine to see if it is safe and effective in protecting against a virus.

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.Check my eligibility
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.See study design
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
Select...
I have tested positive for HSV-2.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with AEs Leading to Discontinuation From Study
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with Medically-Attended AEs (MAAEs)
+3 more
Secondary outcome measures
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)
+6 more

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).

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,760 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals under the age of 55 eligible for participation in this medical trial?

"The trial requirements dictate that participants must be aged 18-55."

Answered by AI

Is the experiment being conducted in numerous medical centers across North America?

"Noble Clinical Research in Tucson, Arizona, Cedars-Sinai Medical Center/Carbon Health in Beverly Hills, California and Artemis Institute for Clinical Research in Riverside, Florida are just some of the sites offering this trial to patients. Moreover, 25 other locations have been recruited."

Answered by AI

How many participants is this trial accepting?

"This trial necessitates 300 suitable participants, who can join from any of the participating medical sites such as Noble Clinical Research in Tucson, Arizona and Cedars-Sinai Medical Center/Carbon Health in Beverly Hills, California."

Answered by AI

Are individuals invited to take part in this inquiry currently?

"According to the clinicaltrials.gov database, this research project is currently accepting volunteers. The first listing for this trial was posted on September 6th of 2023 and it has since been updated as recently as September 11th of that same year."

Answered by AI

Is it possible for me to be involved in this clinical trial?

"To take part in this medical trial, eligible participants must have genital herpes and fall within the age bracket between 18-55 years old. At present 300 individuals are being recruited for participation."

Answered by AI

Who else is applying?

What site did they apply to?
Acclaim Clinical Research
Artemis Institute for Clinical Research
Velocity Clinical Research, Austin
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

To help research on this topic. I need the money and I hate outbreaks. Hsv 1 genital herpe candidate fighting for a cure.
PatientReceived 2+ prior treatments
I am hoping the trial will address my condition. Help find a cure.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

how often are the visits?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. DM Clinical Research: < 24 hours
  2. Multi-Therapeutic Research Associates, Inc.: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
2023. "A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033261.
All > Genital Herpes > Tucson
~237 spots leftby Jun 2025
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