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Dosisfindende forsøg til evaluering af sikkerheden og immunogeniciteten af ​​Cytomegalovirus (CMV)-vaccine mRNA-1647 hos raske voksne

1. maj 2026 opdateret af: ModernaTX, Inc.

Et fase 2, randomiseret, observatørblindt, placebokontrolleret, dosisfindende forsøg til evaluering af sikkerheden og immunogeniciteten af ​​cytomegalovirusvaccine mRNA-1647 hos raske voksne

Dette kliniske studie vil vurdere sikkerheden og immunogeniciteten af ​​3 dosisniveauer af mRNA-1647 cytomegalovirusvaccine hos CMV-seronegative og CMV-seropositive raske voksne 18-40 år.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

mRNA-1647-P202 er et 2-delt studie. Del 1 af undersøgelsen evaluerer sikkerheden og immunogeniciteten af ​​lave, mellemstore og høje dosisniveauer af mRNA-1647-vaccine eller placebo, administreret efter en 0, 2, 6-måneders tidsplan hos raske CMV-seronegative og CMV-seropositive mænd og kvinder , 18 til 40 år. En planlagt foreløbig analyse af sikkerhed og immunogenicitet til og med 3. måned (1 måned efter den anden dosis) i del 1 af undersøgelsen informerede valget af det mellemste dosisniveau til videre udvikling. Del 2 af undersøgelsen er designet til yderligere at evaluere sikkerheden og immunogeniciteten af ​​mellemdosisniveauet af mRNA-1647-vaccine eller placebo på et 0, 2, 6-måneders skema hos ca. 200 raske deltagere i alderen 18 til 40 år, bestående af CMV-seronegative og CMV-seropositive kvindelige populationer, som inkluderer målpopulationen for det pivotale fase 3-effektivitetsforsøg.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

315

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95864
        • Benchmark Research
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61614
        • Optimal Research
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Johnson County Clin-Trials
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Alliance for Multispecialty Research
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213-6523
        • Aventiv Research Inc
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Tekton Research Inc
      • Victoria, Texas, Forenede Stater, 77901
        • Crossroads Clinical Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84109
        • Foothill Family Clinic
      • Salt Lake City, Utah, Forenede Stater, 84121
        • Foothill Family Clinic-South 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

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Mand eller kvinde 18-40 år (del 1); Kvinde 18-40 år (del 2)
  • Forstår og accepterer at overholde forsøgsprocedurerne og giver skriftligt informeret samtykke
  • I henhold til efterforskerens vurdering er den ved et generelt godt helbred og er i stand til at overholde forsøgsprocedurer
  • Kropsmasseindeks (BMI) 18-35 kg/meter (kg/m^2)
  • Kvindelige deltagere skal enten være i den fødedygtige alder eller bruge acceptable præventionsmetoder fra mindst 28 dage før den første vaccination og gennem 3 måneder efter sidste vaccination og ammer ikke.
  • Mandlige deltagere skal acceptere at praktisere tilstrækkelig prævention fra tidspunktet for den første vaccination og frem til 3 måneder efter den sidste vaccination.

Ekskluderingskriterier:

  • Akut syg eller feber på dagen for den første vaccination
  • Forudgående modtagelse af enhver CMV-vaccine
  • Unormale resultater af screeningssikkerhedslaboratorietest
  • Diagnose eller tilstand, der efter Investigators vurdering er klinisk ustabil eller kan påvirke deltagernes sikkerhed, vurdering af sikkerhedsendepunkter, vurdering af immunrespons eller overholdelse af forsøgsprocedurer
  • Har modtaget eller planlægger at modtage en vaccine ≤28 dage før den første vaccination eller planlægger at modtage en ikke-undersøgelsesvaccine inden for 28 dage før eller efter enhver undersøgelsesvaccination, bortset fra enhver godkendt influenzavaccine, som kan administreres >14 dage før eller efter enhver undersøgelsesvaccination. COVID-19-vacciner (uanset producent) kan administreres >7 dage, men helst >14 dage før eller efter enhver undersøgelsesvaccination, med den hensigt at prioritere COVID-19-vaccination frem for alle andre overvejelser.
  • Forudgående modtagelse af kroniske systemiske immunsuppressiva eller immunmodificerende lægemidler
  • Modtagelse af intravenøse immunoglobuliner eller plasmaprodukter inden for 3 måneder før dagen for den første undersøgelsesvaccination
  • Tidligere modtagelse af medicin i lipid nanopartikel (LNP) formulering (kun del 1 deltagere)
  • Har doneret ≥450 milliliter (ml) blodprodukter inden for 28 dage efter screeningsbesøget
  • Deltog i et interventionelt klinisk forsøg inden for 28 dage før tilmeldingsdagen
  • Er et nært familiemedlem eller husstandsmedlem af forsøgspersonale

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Deltagerne vil modtage placebo, der matcher mRNA-1647-vaccinedosis ved IM-injektion på dag 1, dag 56 og dag 168.
Andet: Placebo
0,9% natriumchlorid (normalt saltvand) injektion
Eksperimentel: mRNA-1647 Dosisniveau A
Deltagerne vil modtage mRNA-1647-vaccine på dosisniveau A ved intramuskulær (IM) injektion på dag 1, dag 56 og dag 168.
Biologisk: mRNA-1647
Lyofiliseret produkt, der rekonstitueres med saltvand og derefter fortyndes med et specielt fortyndingsmiddel for at nå den ønskede koncentration
Eksperimentel: mRNA-1647 Dosisniveau B
Deltagerne vil modtage mRNA-1647-vaccine på dosisniveau B ved IM-injektion på dag 1, dag 56 og dag 168.
Biologisk: mRNA-1647
Lyofiliseret produkt, der rekonstitueres med saltvand og derefter fortyndes med et specielt fortyndingsmiddel for at nå den ønskede koncentration
Eksperimentel: mRNA-1647 Dosisniveau C
Deltagerne vil modtage mRNA-1647-vaccine på dosisniveau C ved IM-injektion på dag 1, dag 56 og dag 168.
Biologisk: mRNA-1647
Lyofiliseret produkt, der rekonstitueres med saltvand og derefter fortyndes med et specielt fortyndingsmiddel for at nå den ønskede koncentration

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Tidsramme: Up to Day 175 (7 days following last dose administration)
Solicited ARs were selected signs and symptoms occurring after vaccination administration during a specified post-vaccination follow-up period. The occurrence and intensity of the selected signs and symptoms was actively solicited from the participant during a specified post-vaccination follow-up period (day of vaccination and 6 subsequent days), using a predefined checklist in the electronic diary. The following local ARs were solicited: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the vaccination arm. The following systemic ARs were solicited: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, fever, and chills. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to Day 175 (7 days following last dose administration)
Number of Participants With Unsolicited Adverse Events (AEs)
Tidsramme: Up to Day 196 (28 days following last dose administration)
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Up to Day 196 (28 days following last dose administration)
Number of Participants With Medically Attended Adverse Events (MAAEs)
Tidsramme: Up to Day 336 (6 months following last dose administration)
An MAAE is an AE that lead to a visit to a healthcare practitioner (HCP). This would include visits to study clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up), and visits to HCPs external to the clinical site (for example, urgent care, primary care physician). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Up to Day 336 (6 months following last dose administration)
Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: Up to Day 504 (1 year following last dose administration)
An SAE was defined as any untoward medical occurrence that, in the view of either the Investigator or the Sponsor, resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Up to Day 504 (1 year following last dose administration)
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Tidsramme: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity (AMI) analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Geometric Mean Ratio (GMR) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Tidsramme: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) Over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Tidsramme: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z * the lower limit of quantification (LLOQ) for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
GMT of Anti-Glycoprotein B (gB)-Specific Immunoglobulin G (IgG) and Anti-Pentamer-specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Tidsramme: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-pentameric gH/gL/UL128/UL130/UL131A glycoprotein complex (Pentamer)-specific IgG binding was measured with ELISA. The GMT measures the level of inhibition of anti-gB-specific IgG (anti-gB) and anti-Pentamer-specific IgG (anti-Pentamer) against cytomegalovirus. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Anti-gB-specific IgG and Anti-Pentamer-specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Tidsramme: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Number Analyzed = participants who were evaluable at specified timepoints.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Tidsramme: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Tidsramme: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection in the CMV-Seropositive and CMV-Seronegative Groups
Tidsramme: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z * the LLOQ for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Tidsramme: Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Tidsramme: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504

Samarbejdspartnere og efterforskere

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

Sponsor

ModernaTX, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

9. januar 2020

Primær færdiggørelse (Faktiske)

4. januar 2023

Studieafslutning (Faktiske)

4. januar 2023

Datoer for studieregistrering

Først indsendt

9. januar 2020

Først indsendt, der opfyldte QC-kriterier

14. januar 2020

Først opslået (Faktiske)

18. januar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • mRNA-1647-P202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 Cytomegalovirus infektion

Kliniske forsøg med mRNA-1647

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