Uno studio per valutare l'effetto di CD388 sull'immunogenicità del vaccino Fluzone® HD
Uno studio di Fase 1, in doppio cieco, randomizzato per valutare la sicurezza e l'immunogenicità del vaccino antinfluenzale Fluzone® ad alta dose quando somministrato in concomitanza con CD388, un nuovo coniugato antivirale a lunga durata d'azione per la prevenzione dell'influenza
Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021). Researchers are looking for other ways to prevent severe illness from the influenza virus.
The goals of this study are to learn if:
- MK-1406 (formerly CD388) is safe to take with Fluzone®
- MK-1406 affects the immune response to Fluzone®
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is a Phase 1, double-blind, randomized trial to evaluate the immunogenicity of Fluzone® HD influenza vaccine when concomitantly administered with either MK-1406 or placebo, in healthy participants. This study will also evaluate the safety and tolerability of MK-1406 when administered with Fluzone® High-Dose (HD) compared to Fluzone® HD with placebo.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Toll Free Number
- Numero di telefono: 1-888-577-8839
- Email: Trialsites@msd.com
Luoghi di studio
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California
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Glendale, California, Stati Uniti, 91206
- Reclutamento
- Parexel ( Site 0001)
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Contatto:
- Study Coordinator
- Numero di telefono: 888-228-7425
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Maryland
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Baltimore, Maryland, Stati Uniti, 21225
- Reclutamento
- Parexel ( Site 0002)
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Contatto:
- Study Coordinator
- Numero di telefono: 410-350-3200
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Be ≥18 to ≤49 years of age
- Be deemed healthy by the Investigator
- Have not received any seasonal influenza vaccine and have not had a diagnosed or suspected influenza infection within 12 months prior to Day 1 of the trial
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Had an active malignancy within 5 years prior to screening, except basal cell or squamous cell skin cancer. Any history of breast cancer or melanoma is exclusionary.
- Has previously been diagnosed with Guillain-Barre Syndrome following a previous influenza vaccination.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Fluzone® High-Dose (HD) plus MK-1406
Participants will receive open-label Fluzone® HD influenza vaccine by intramuscular (IM) injection plus MK-1406 by subcutaneous (SC) injection on Day 1. |
Fluzone® HD injectable suspension administered by intramuscular (IM) injection
Altri nomi:
MK-1406 liquid for injection administered subcutaneously
Altri nomi:
|
|
Comparatore placebo: Fluzone® HD plus Placebo
Participants will receive open-label Fluzone® HD influenza vaccine by IM injection plus placebo by SC injection on Day 1. |
Fluzone® HD injectable suspension administered by intramuscular (IM) injection
Altri nomi:
MK-1406 matched liquid for SC injection |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Geometric Mean of Hemagglutinin Inhibition (HAI) Titers Against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® High-Dose (HD) and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
Lasso di tempo: Predose (Day 1), Day 15 and Day 29
|
Geometric mean of HAI titers at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. HAI testing will be performed using validated methods in accordance with applicable Good Clinical Laboratory Practice (GCLP) and laboratory Standard Operating Procedures (SOPs). Geometric Mean Titers (GMTs) will be summarized by treatment group and influenza strain. |
Predose (Day 1), Day 15 and Day 29
|
|
Percentage of Participants with Seroconversion Rates against the Influenza Strains Contained in the Vaccine Among Participants Receiving Concomitant Fluzone® HD and MK-1406 Compared to Participants Who Receive Fluzone® HD and Placebo
Lasso di tempo: Predose (Day 1), Day 15 and Day 29
|
Seroconversion is defined as a 4-fold increase in influenza titer as measured by HAI assay at each visit compared to baseline. Seroconversion rates at 2-weeks and 4-weeks post-trial intervention against the influenza virus strains contained in the vaccine among participants receiving concomitant Fluzone® HD influenza vaccine and MK-1406 compared to participants who receive Fluzone® HD and placebo will be determined. Seroconversion rates will be summarized by treatment group and influenza strain. |
Predose (Day 1), Day 15 and Day 29
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of participants with ≥1 Adverse Event (AE)
Lasso di tempo: Up to approximately Day 29
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
Up to approximately Day 29
|
|
Percentage of Participants Who Discontinued from the Study Due to an Adverse Event
Lasso di tempo: Up to approximately Day 29
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued the study because of an AE (as defined above) will be assessed. |
Up to approximately Day 29
|
|
Percentage of Participants with a Solicited Injection-site Adverse Event
Lasso di tempo: Up to approximately Day 8 post-dose
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. |
Up to approximately Day 8 post-dose
|
|
Percentage of Participants with a Solicited Systemic Adverse Event
Lasso di tempo: Up to approximately Day 29
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
Up to approximately Day 29
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1406-007
- CD388.SQ.1.08 (Altro identificatore: Cidara)
- MK-1406-007 (Altro identificatore: MSD)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
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