A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants

Официальное название

A Phase 1, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants 18 to 65 Years of Age

Обзор

The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1469

Вмешательства

• Биопрепарат mRNA-1469
  Sterile liquid for injection
• Биопрепарат Placebo
  Sterile liquid for injection

Первичные конечные точки

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Срок оценки: Up to Day 7 (the day of study intervention and 6 subsequent days)]
• Number of Participants with Unsolicited Adverse Events (AEs) [Срок оценки: Up to Day 28 (the day of study intervention and 27 subsequent days)]
• Number of Participants with Medically Attended Adverse Events (MAAEs) [Срок оценки: Up to Day 169 (6 months follow-up after injection)]
• Number of Participants with Serious Adverse Events (SAEs), Any AEs Leading to Discontinuation From Study Participation and/or Study Vaccination, and AEs of Special Interest (AESIs) [Срок оценки: Up to End of Study (EOS) (Day 337)]

Вторичные конечные точки (1)

• Geometric Mean of Bundibugyo Ebolavirus (BDBV)-Specific Binding Antibodies (bAbs) [Срок оценки: At Day 29 and Up to Day 337]

Критерии участия

Критерии включения

• In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• Body mass index within the range 18.5 to 39 kg/m2 (inclusive).
• Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.

Критерии исключения

• History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
• History of participation in a prior vaccine study for pathogens causing Ebola virus disease.
• History of confirmed or suspected filovirus exposure or infection or travel to an impacted area within 1 month prior to the Screening Visit (e.g. Ebola Zaire, Sudan, BDBV, and Marburg).
• Other conditions that in the Investigator's opinion could interfere with interpretation of study results or limit the participant's participation in the study.
• Acutely ill or febrile (temperature ≥38.0℃ \[100.4°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
• Abnormal screening clinical laboratory values >Grade 1 for total white blood cell count, hemoglobin, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, total bilirubin, or platelets.
• History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.

Note: Other inclusion and exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Канада · 3 центра

• Canadian Center for Vaccinology — Halifax
• Colchester Research Group — Truro
• Centricity Research Toronto LMC Multispecialty — Toronto

Идентификаторы

NCT: NCT07737717 · mRNA-1469-P101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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