Genital Herpes
Conditions
Keywords
HSV-2, Herpes Simplex Virus Type 2, HSV-2 vaccine, Genital Herpes, mRNA-1608
Brief 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.
Detailed description
Participants with a history of recurrent genital herpes will be randomly assigned in a 1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO) administered as 2 doses at 0 and 2 months (Day 1 and Day 57).
Interventions
BIOLOGICALmRNA-1608
Sterile liquid for injection
BIOLOGICALBEXSERO
A vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 64 (7 days after each injection) |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 85 (28 days after each injection) |
| Number of Participants with Serious Adverse Events (SAEs) | Day 1 to Day 393 (end of study [EoS]) |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Day 1 to Day 393 (EoS) |
| Number of Participants with AEs Leading to Discontinuation From Study | Day 1 to Day 393 (EoS) |
| Number of Participants with Medically-Attended AEs (MAAEs) | Day 1 through 6 months after last study injection (Day 225) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) at 1 and 6 Months After the Second Study Injection | Days 85 and 225 | — |
| Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection | Day 71 to Day 225 | — |
| Number of Participants With Vaccine Seroresponse | Baseline (Day 1), Days 85 and 225 | Seroresponse is defined by an increase in HSV-2 bAb levels at Day 85 and Day 225 ≥4-fold if baseline level is above the lower level of quantitation (LLOQ) or ≥4 × LLOQ if baseline bAb level is \<LLOQ prior to study injection. |
| Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs From Baseline to 1 and 6 Months After the Second Study Injection | Baseline (Day 1), Days 85 and 225 | — |
| Number of Genital Herpes Recurrences, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection | Day 71 to Day 393 | — |
| 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) | Baseline (Day -27 to Day 1), Day 85 to Day 113 | To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 85 to Day 113 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline). |
| 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) | Baseline (Day -27 to Day 1), Day 197 to Day 225 | To calculate the 'Change from Baseline', the herpes lesion rate during the timeframe of Day 197 to Day 225 will be compared against the herpes lesion rate during the timeframe of Day -27 to Day 1 (Baseline). |
| 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) | Baseline (Day -27 to Day 1), Day 85 to Day 113 | To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 85 to Day 113 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline). |
| Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Proportion of HSV-2 DNA Positive Anogenital Swabs) | Baseline (Day -27 to Day 1), Day 197 to Day 225 | To calculate the 'Change from Baseline', the HSV-2 genital shedding rate during the timeframe of Day 197 to Day 225 will be compared against the HSV-2 genital shedding rate during the timeframe of Day -27 to Day 1 (Baseline). |
Countries
United States
Outcome results
None listed