A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy… (NCT06033261) | Clinical Trial Compass
CompletedPhase 1/2
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
United States303 participantsStarted 2023-09-06
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 meningiti…
What they're measuring
1
Number of Participants With Solicited Local and Systemic ARs
Timeframe: Up to Day 64 (Within 7 days after study vaccination)
2
Number of Participants With Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 85 (Up to 28 days after study vaccination)
3
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
Timeframe: Day 1 through Day 393
4
Number of Participants With Medically Attended AEs (MAAEs)