Um Estudo para Avaliar o Efeito do CD388 na Imunogenicidade da Vacina Fluzone® HD
Um Estudo de Fase 1, Duplamente Cego e Randomizado para Avaliar a Segurança e Imunogenicidade da Vacina Fluzone® de Alta Dose Contra a Gripe, quando Administrada Concomitantemente com o CD388, um Novo Conjugado Antiviral de Longa Duração para a Prevenção da Gripe
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®
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Toll Free Number
- Número de telefone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Locais de estudo
-
-
California
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Glendale, California, Estados Unidos, 91206
- Recrutamento
- Parexel ( Site 0001)
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Contato:
- Study Coordinator
- Número de telefone: 888-228-7425
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Maryland
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Baltimore, Maryland, Estados Unidos, 21225
- Recrutamento
- Parexel ( Site 0002)
-
Contato:
- Study Coordinator
- Número de telefone: 410-350-3200
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
Outros nomes:
MK-1406 liquid for injection administered subcutaneously
Outros nomes:
|
|
Comparador de 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
Outros nomes:
MK-1406 matched liquid for SC injection |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of participants with ≥1 Adverse Event (AE)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1406-007
- CD388.SQ.1.08 (Outro identificador: Cidara)
- MK-1406-007 (Outro identificador: MSD)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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