BENITIONSClinical Trial Intelligence

Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

第2相 完了 NCT04232280

対象疾患Cytomegalovirus Infection
第2相
スポンサーModernaTX, Inc.
ステータス完了
参加者数315 名
介入(薬剤)mRNA-1647
開始日2020年1月9日
完了日2023年1月4日
結果公開日2026年5月5日

概要

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
Seronegative mRNA-1647 (100 ug)59 Participants
Seronegative mRNA-1647 (150 ug)40 Participants
Seronegative Placebo12 Participants
Seropositive mRNA-1647 (50 ug)15 Participants
Seropositive mRNA-1647 (100 ug)33 Participants

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
Seronegative mRNA-1647 (100 ug)31 Participants
Seronegative mRNA-1647 (150 ug)18 Participants
Seronegative Placebo21 Participants
Seropositive mRNA-1647 (50 ug)10 Participants
Seropositive mRNA-1647 (100 ug)16 Participants

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
Seronegative mRNA-1647 (100 ug)24 Participants
Seronegative mRNA-1647 (150 ug)14 Participants
Seronegative Placebo19 Participants
Seropositive mRNA-1647 (50 ug)5 Participants
Seropositive mRNA-1647 (100 ug)11 Participants

BENITIONS で見る ClinicalTrials.gov の原文を見る

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