Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Фаза 2
Завершено
NCT04232280
| Заболевание | Cytomegalovirus Infection |
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| Фаза | Фаза 2 |
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| Спонсор | ModernaTX, Inc. |
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| Статус | Завершено |
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| Участники | 315 участн. |
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| Вмешательство | mRNA-1647 |
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| Дата начала | 9.01.2020 |
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| Дата завершения | 4.01.2023 |
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| Публикация результатов | 5.05.2026 |
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Кратко
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 175 (7 days following last dose administration) · Participants
| Seronegative mRNA-1647 (50 ug) | 33 Participants |
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| Seronegative mRNA-1647 (100 ug) | 59 Participants |
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| Seronegative mRNA-1647 (150 ug) | 40 Participants |
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| Seronegative Placebo | 12 Participants |
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| Seropositive mRNA-1647 (50 ug) | 15 Participants |
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| Seropositive mRNA-1647 (100 ug) | 33 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs)
Up to Day 196 (28 days following last dose administration) · Participants
| Seronegative mRNA-1647 (50 ug) | 16 Participants |
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| Seronegative mRNA-1647 (100 ug) | 31 Participants |
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| Seronegative mRNA-1647 (150 ug) | 18 Participants |
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| Seronegative Placebo | 21 Participants |
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| Seropositive mRNA-1647 (50 ug) | 10 Participants |
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| Seropositive mRNA-1647 (100 ug) | 16 Participants |
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Number of Participants With Medically Attended Adverse Events (MAAEs)
Up to Day 336 (6 months following last dose administration) · Participants
| Seronegative mRNA-1647 (50 ug) | 13 Participants |
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| Seronegative mRNA-1647 (100 ug) | 24 Participants |
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| Seronegative mRNA-1647 (150 ug) | 14 Participants |
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| Seronegative Placebo | 19 Participants |
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| Seropositive mRNA-1647 (50 ug) | 5 Participants |
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| Seropositive mRNA-1647 (100 ug) | 11 Participants |
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