A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age

Официальное название

A Phase 1, Randomized, Open-label Study to Evaluate Safety, Reactogenicity, and Immunogenicity of an Epstein-Barr Virus Candidate Vaccine, mRNA-1189, Following Intradermal and Intramuscular Delivery in Healthy Adults 18 to 30 Years of Age

Обзор

The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.

Вмешательства

• Биопрепарат mRNA-1189
  Sterile liquid for injection

Первичные конечные точки

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Срок оценки: Up to Day 64 (7-day follow-up after vaccination)]
• Number of Participants with Unsolicited Adverse Events (AEs) [Срок оценки: Up to Day 85 (28-day follow-up after vaccination)]
• Number of Participants with Medically Attended Adverse Events (MAAEs) [Срок оценки: Day 1 up to Day 225]
• Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs) [Срок оценки: Day 1 to end of study (EOS) (Day 225)]

Вторичные конечные точки (3)

• Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb) [Срок оценки: Days 1 and 85]
• Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb [Срок оценки: Day 85]
• Number of Participants With Seroconversion of Antigen-Specific bAbs [Срок оценки: Day 85]

Критерии участия

Критерии включения

• Healthy as determined by medical evaluation including medical history and physical examination.
• Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.

Критерии исключения

• Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
• Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
• Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
• Received or plans to receive any nonstudy vaccine from 28 days prior to first dose/Day 1 up to 28 days after the second dose/Day 57.
• History of myocarditis, pericarditis, or myopericarditis prior to Day 1.
• Has previously received an investigational EBV vaccine.

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

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Австралия · 2 центра

• Nucleus Network — Melbourne
• Doherty Clinical Trials — Melbourne

Идентификаторы

NCT: NCT07478952 · mRNA-NEXT-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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