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

Launched by MODERNATX, INC. · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called mRNA-1608, which aims to help people with recurrent genital herpes caused by the herpes simplex virus type 2 (HSV-2). The main goals of the study are to check how safe the vaccine is and to see if it can help the immune system fight off the virus. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants must be healthy adults aged 18 to 55 who have been diagnosed with genital HSV-2 infection for at least a year and have experienced between 3 to 9 outbreaks in the past year. Participants will need to stop taking certain antiviral medications during the trial to accurately assess the vaccine's effects. Throughout the study, they will receive the vaccine and have regular check-ups to monitor their health. This trial is important as it may provide insights into a potential new treatment option for those suffering from recurrent genital herpes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant has a diagnosis of genital HSV-2 infection for at least 1 year before the Screening Visit.
• • Seropositive for HSV-2 as determined by Western Blot.
• • Participant has a history of recurrent genital herpes defined as at least 3 and no more than 9 reported genital herpes recurrences in the 12 months preceding the Screening Visit, or if currently on suppressive therapy, prior to initiation of suppressive therapy.
• • Willing to refrain from taking suppressive antiviral therapy from the Screening Visit until the end of the study.
• • Willing to refrain from the use of episodic antiviral therapy during the three 28-day anogenital swabbing periods. Episodic therapy may be used outside the three 28-day swabbing periods.
• • For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.
• Exclusion Criteria:
• • Prior immunization with a vaccine containing HSV antigens.
• • History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
• • 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).
• • Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
• • Previously received BEXSERO or other vaccine to prevent serogroup B meningococcal disease (also known as meningitis B).
• • History of allergic disease or reactions likely to be exacerbated by any component of BEXSERO vaccine.
• • Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤ 28 days prior to the first study injection (Day 1), or plans to receive a licensed or authorized vaccine within 28 days before or after study injection with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study injection.
• • Note: Other inclusion and exclusion criteria may apply.