Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1608 · 1 trial · 1 indication
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
| Arm | Type | Description |
|---|---|---|
| mRNA-1608 Dose A | EXPERIMENTAL | 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). |
| mRNA-1608 Dose B | EXPERIMENTAL | 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). |
| mRNA-1608 Dose C | EXPERIMENTAL | 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). |
| BEXSERO | OTHER | Participants will receive 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). |
| Name | Type | Description |
|---|---|---|
| mRNA-1608 | BIOLOGICAL | Sterile liquid for injection |
| BEXSERO | BIOLOGICAL | A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. |
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 herp...
mRNA-1608 is an investigational mRNA vaccine developed by Moderna for genital herpes caused by herpes simplex virus type 2 (HSV-2). It is designed as a therapeutic candidate vaccine, meaning it is being studied in people who already have recurrent HSV-2 genital herpes rather than as a preventive shot for people who have not been infected.
mRNA-1608 is being studied for recurrent HSV-2 genital herpes in adults. It is a therapeutic candidate vaccine, so the goal of the program is to treat people who already carry HSV-2 and experience recurrent outbreaks, not to prevent initial infection. It remains investigational and has not been approved for use.
mRNA-1608 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program for the candidate vaccine in genital herpes.
mRNA-1608 is in Phase 1 clinical development. It is an investigational vaccine and is not approved by the FDA or any other regulator. The Phase 1 study of mRNA-1608 has been completed, and no trials of the candidate are currently listed as active.
mRNA-1608 has been evaluated in one clinical trial, NCT06033261, titled a study of mRNA-1608, a herpes simplex virus-2 therapeutic candidate vaccine, in healthy adults 18 to 55 years of age with recurrent HSV-2 genital herpes. The Phase 1 trial enrolled 303 participants in the United States and is completed.
The Phase 1 trial NCT06033261 was a randomized, double-blind, controlled study of mRNA-1608 in adults aged 18 to 55 with recurrent HSV-2 genital herpes. It enrolled 303 participants across sites in the United States and included both male and female participants. The study is listed as completed.