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En undersøgelse af mRNA-1608, en Herpes Simplex Virus -2 (HSV-2) terapeutisk kandidatvaccine, hos raske voksne i alderen 18 til 55 år med tilbagevendende HSV-2 genital herpes

17. april 2026 opdateret af: ModernaTX, Inc.

En fase 1/2, randomiseret, observatør-blind, kontrolleret, dosisvarierende undersøgelse af mRNA-1608, en HSV-2 terapeutisk kandidatvaccine, hos raske voksne i alderen 18 til 55 år med tilbagevendende HSV-2 genital herpes

Formålet med denne undersøgelse er at generere sikkerheds- og immunogenicitetsdata og etablere et proof-of-concept for klinisk fordel ved mRNA-1608-vaccinekandidaten.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Deltagere med en historie med tilbagevendende genital herpes vil blive tilfældigt tildelt i forholdet 1:1:1:1 til at modtage mRNA-1608 ved 1 af de 3 dosisniveauer eller kontrol (BEXSERO) administreret som 2 doser efter 0 og 2 måneder (dag) 1 og dag 57).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

303

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35218
        • Accel Clinical Sites Network - Cahaba Medical Care
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85704
        • Noble Clinical Research
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Cedars-Sinai Medical Center/Carbon Health
      • San Diego, California, Forenede Stater, 92120
        • Acclaim Clinical Research
    • Florida
      • Lake City, Florida, Forenede Stater, 32055
        • Multi-Specialty Research Associates, Inc.
      • Miami, Florida, Forenede Stater, 33173
        • Suncoast Research Associates, LLC
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Johnson County Clin-Trials (JCCT)
      • Newton, Kansas, Forenede Stater, 67114
        • Alliance For multispecialty Research, LLC
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70125
        • Research Works
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Fenway Health
    • Michigan
      • Southfield, Michigan, Forenede Stater, 48076
        • DM Clinical Research
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Velocity Clinical Research
      • Norfolk, Nebraska, Forenede Stater, 68701
        • Velocity Clinical Research
    • New York
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27612
        • M3 Wake Research, Inc.
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • Velocity Clinical Research Cleveland
    • Texas
      • Cedar Park, Texas, Forenede Stater, 78613
        • Velocity Clinical Research, Austin
      • Fort Worth, Texas, Forenede Stater, 76107
        • Helios CR, Inc Fort Worth
      • Houston, Texas, Forenede Stater, 77081
        • DM Clinical Research
      • San Antonio, Texas, Forenede Stater, 78215
        • Sun Research Institute
      • Tomball, Texas, Forenede Stater, 77064
        • DM Clinical Research
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • Health Research of Hampton Roads
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington Virology Research Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Deltageren har en diagnose af genital HSV-2-infektion i mindst 1 år før screeningsbesøget.
  • Seropositiv for HSV-2 som bestemt ved Western Blot.
  • Deltageren har en historie med tilbagevendende genital herpes defineret som mindst 3 og ikke mere end 9 rapporterede genital herpes-gentagelser i de 12 måneder forud for screeningsbesøget, eller hvis aktuelt er i suppressiv behandling, før påbegyndelse af suppressiv terapi.
  • Villig til at afstå fra at tage suppressiv antiviral terapi fra screeningsbesøget indtil afslutningen af ​​undersøgelsen.
  • Villig til at afstå fra brugen af ​​episodisk antiviral terapi i de tre 28-dages anogenitale podningsperioder. Episodisk terapi kan anvendes uden for de tre 28-dages podningsperioder.
  • For kvindelige deltagere i den fødedygtige alder: negativ graviditetstest, tilstrækkelig prævention og ikke i øjeblikket amning.

Ekskluderingskriterier:

  • Forudgående immunisering med en vaccine indeholdende HSV-antigener.
  • Anamnese med enhver form for okulær HSV-infektion, HSV-relateret erythema multiforme eller HSV-relaterede neurologiske komplikationer.
  • Anamnese med genital HSV-1-infektion.
  • Anamnese med hepatitis B, hepatitis C eller human immundefektvirus (HIV) type 1 eller 2 (HIV-1, HIV-2).
  • Rapporteret historie med anafylaksi eller alvorlig overfølsomhedsreaktion efter modtagelse af enhver mRNA-vaccine(r) eller en hvilken som helst af komponenterne i mRNA-vaccinerne.
  • Har tidligere modtaget BEXSERO eller anden vaccine for at forhindre serogruppe B meningokoksygdom (også kendt som meningitis B).
  • Anamnese med allergisk sygdom eller reaktioner, der sandsynligvis vil blive forværret af en komponent i BEXSERO-vaccinen.
  • Har modtaget eller planlægger at modtage en licenseret eller autoriseret vaccine, inklusive COVID-19-vacciner, ≤ 28 dage før den første undersøgelsesinjektion (dag 1), eller planlægger at modtage en licenseret eller autoriseret vaccine inden for 28 dage før eller efter undersøgelsesinjektion med med undtagelse af godkendte influenzavacciner, som kan modtages mere end 14 dage før eller efter enhver undersøgelsesinjektion.

Bemærk: Andre inklusions- og eksklusionskriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: mRNA-1608 Dosis A
Deltagerne vil modtage 2 intramuskulære (IM) injektioner af mRNA-1608 på dosisniveau A, hver dosis administreret efter 0 og 2 måneder (dag 1 og dag 57).
Biologisk: mRNA-1608
Steril væske til injektion
Eksperimentel: mRNA-1608 Dosis B
Deltagerne vil modtage 2 IM-injektioner af mRNA-1608 på dosisniveau B, hver dosis administreret efter 0 og 2 måneder (dag 1 og dag 57).
Biologisk: mRNA-1608
Steril væske til injektion
Eksperimentel: mRNA-1608 Dosis C
Deltagerne vil modtage 2 IM-injektioner af mRNA-1608 på dosisniveau C, hver dosis administreret efter 0 og 2 måneder (dag 1 og dag 57).
Biologisk: mRNA-1608
Steril væske til injektion
Andet: BEXSERO
Deltagerne vil modtage 2 im-injektioner af BEXSERO, hver dosis administreret efter 0 og 2 måneder (dag 1 og dag 57).
Biologisk: BEXSERO
En vaccine indiceret til aktiv immunisering for at forhindre invasiv sygdom forårsaget af Neisseria meningitidis serogruppe B.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Solicited Local and Systemic ARs
Tidsramme: Up to Day 64 (Within 7 days after study vaccination)
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.
Up to Day 64 (Within 7 days after study vaccination)
Number of Participants With Unsolicited Adverse Events (AEs)
Tidsramme: Up to Day 85 (Up to 28 days after study vaccination)
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.
Up to Day 85 (Up to 28 days after study vaccination)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation
Tidsramme: Day 1 through Day 393
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.
Day 1 through Day 393
Number of Participants With Medically Attended AEs (MAAEs)
Tidsramme: Day 1 through Day 393
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.
Day 1 through Day 393

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection
Tidsramme: Day 71 up to Day 225
An episode of recurrence was defined as one or more consecutive "yes" to the "Do you have genital herpes lesion?" question either from Genital Herpes Signs and Symptoms (GHSS) or daily recurrence eDiary within a 14-day period from the first "yes" response regardless of "no" or missing entries in between. The start date of an episode was the first date of "yes" response, and the end date of an episode was the last date of "yes" within the episode. The recurrence analysis period up to 6 months included the time from 14 days after the second injection until the last GHSS or daily recurrence eDiary collected up to the 1) the Day 225 visit date or 2) if Day 225 visit date is not available, the earliest of study Day 225 or study discontinuation date.
Day 71 up to Day 225
Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection
Tidsramme: Day 71 up to Day 393
An episode of recurrence was defined as one or more consecutive "yes" to the "Do you have genital herpes lesion?" question either from GHSS or daily recurrence eDiary within a 14-day period from the first "yes" response regardless of "no" or missing entries in between. The start date of an episode was the first date of "yes" response, and the end date of an episode was the last date of "yes" within the episode. The recurrence analysis period up to 12 months included the time from 14 days after the second injection until the last GHSS or daily recurrence eDiary collected up to the 1) the Day 393 visit date or 2) if Day 393 visit date is not available, the earliest of study Day 393 or study discontinuation date.
Day 71 up 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 (Percentage of Days With Lesions Present)
Tidsramme: Baseline (Day -27 to Day 1), Day 113
Genital herpes lesion rate was defined for each 28-day swabbing period as the number of days with lesion present according to the eDiary divided by the number of days during the 28-day swabbing period.
Baseline (Day -27 to Day 1), Day 113
Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Percentage of Days With Lesions Present)
Tidsramme: Baseline (Day -27 to Day 1), Day 225
Genital herpes lesion rate was defined for each 28-day swabbing period as the number of days with lesion present according to the eDiary divided by the number of days during the 28-day swabbing period.
Baseline (Day -27 to Day 1), Day 225
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 (Percentage of HSV-2 Deoxyribonucleic Acid [DNA] Positive Anogenital Swabs)
Tidsramme: Baseline (Day -27 to Day 1), Day 113
Genital shedding rate was defined for each 28-day swabbing period as the number of anogenital swabs with HSV-2 DNA positive results (that is, positive results per polymerase chain reaction [PCR]) divided by the number of swabs during the swabbing period.
Baseline (Day -27 to Day 1), Day 113
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 (Percentage of HSV-2 DNA Positive Anogenital Swabs)
Tidsramme: Baseline (Day -27 to Day 1), Day 225
Genital shedding rate was defined for each 28-day swabbing period as the number of anogenital swabs with HSV-2 DNA positive results (that is, positive results per PCR) divided by the number of swabs during the swabbing period.
Baseline (Day -27 to Day 1), Day 225
Geometric Mean (GM) Value of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs)
Tidsramme: Days 85 and 197
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 1220 units (U)/milliliter (mL) and ULOQ was 6890000 U/mL for HSV2 gB. LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC. LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for GM, then back transformed to the original scale for presentation.
Days 85 and 197
Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs
Tidsramme: Days 85 and 197
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 1220 U/mL and ULOQ was 6890000 U/mL for HSV2 gB. LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC. LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation.
Days 85 and 197
Percentage of Participants With Vaccine Seroresponse
Tidsramme: Day 85
Seroresponse was defined as a change from baseline below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold rise if baseline was equal to or above the LLOQ. LLOQ was 1220 U/mL and ULOQ was 6890000 U/mL for HSV2 gB. LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC. LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD. 95% CI was calculated using the Clopper-Pearson method.
Day 85

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ModernaTX, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. september 2023

Primær færdiggørelse (Faktiske)

25. april 2025

Studieafslutning (Faktiske)

25. april 2025

Datoer for studieregistrering

Først indsendt

5. september 2023

Først indsendt, der opfyldte QC-kriterier

5. september 2023

Først opslået (Faktiske)

13. september 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • mRNA-1608-P101

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Genital Herpes

Kliniske forsøg med mRNA-1608

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kosovo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner