Approval Probability
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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 therapeutic candidate vaccine being studied for the treatment of recurrent genital herpes caused by herpes simplex virus type 2 (HSV-2). It is designed for healthy adults aged 18 to 55 years with a history of recurrent HSV-2 genital herpes.
mRNA-1608 is being developed by Moderna, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol MRNA. The company is conducting clinical research on this candidate vaccine for genital herpes.
mRNA-1608 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, but the candidate remains in early-stage clinical testing.
mRNA-1608 has one completed clinical trial, registered as NCT06033261. This Phase 1 study enrolled 303 participants in the United States and evaluated the candidate vaccine in healthy adults aged 18 to 55 years with recurrent HSV-2 genital herpes.
mRNA-1608 is classified as a therapeutic candidate vaccine, not a monoclonal antibody. It is designed to treat genital herpes caused by HSV-2, and the completed Phase 1 trial was a randomized, double-blind, controlled study.