A Phase 2, Non-Randomized, Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus mRNA-1647 Vaccine Including a Booster Dose in a Subset of Participants Who Completed Study mRNA-1647-P202
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 7
- 主要终点
- BP: Number of Participants with Solicited Adverse Reactions (ARs)
研究概览
简要总结
The main purpose of the extension phase of this study is to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative and CMV-seropositive adults who completed Study mRNA-1647-P202 (NCT04232280). For participants in the optional booster phase (BP), the main purpose is to evaluate the long-term immunogenicity and safety of the mRNA-1647 vaccine in both participants receiving a booster dose (BD) and those not receiving a BD, and to additionally evaluate the reactogenicity in participants receiving a BD.
详细描述
The study aims to explore the long-term potential differences in immunogenicity and key safety parameters following mRNA-1647 administration, participants who completed study mRNA-1647-P202, who are CMV-seronegative and who did not seroconvert due to primary CMV infection during the study will be enrolled. Study mRNA-1647-P202 participants who were CMV-seropositive at baseline, randomized to receive mRNA-1647 injection, and completed their final study visit will also be enrolled.
No study treatment will be administered during the primary extension phase of this study. Eligible participants enrolling in the primary extension phase who completed Study mRNA-1647-P202 may have received mRNA-1647 (either low dose, medium dose, or high dose) or placebo in CMV-seronegative participants and mRNA-1647 (either low dose, medium dose, or high dose) in CMV-seropositive participants.
In the optional BP, consenting and eligible participants will receive a single BD of the mRNA-1647 vaccine (medium dose). In the Observational Group of the optional BP, consenting and eligible participants will not receive study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Extension Phase:
- •Male and female participants who were CMV-seronegative at the Study mRNA-1647-P202 Screening visit, completed the final Study mRNA-1647-P202 visit, and remained CMV-seronegative at Screening for Study mRNA-1647-P202-EXT.
- •Male and female participants who were CMV-seropositive at the Study mRNA-1647-P202 Screening visit, were randomized to receive mRNA-1647 injection (and not placebo), and completed the final visit in Study mRNA-1647-P
- •Understands and agrees to comply with the trial procedures and provides written informed consent.
- •According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures.
- •Optional Booster Phase:
- •For BD Recipients:
- •- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 medium dose injection (and not placebo or other dose levels) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to receive a BD in the optional BP.
- •For Observational Group:
- •- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 low dose or high dose injection (and not placebo or mRNA-1647 medium dose injection) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to enroll in the observational group.
排除标准
- •Primary Extension Phase:
- •Receipt of any CMV vaccine other than mRNA-
- •Diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- •Optional Booster Phase:
- •For BD Recipients:
- •- Participants from the placebo, mRNA-1647 low dose, or mRNA-1647 medium dose groups in Study mRNA-1647-P
- •For Observational Group:
- •- Participants from the placebo or mRNA-1647 medium dose groups in study mRNA-1647-P
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Primary Extension Phase
CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202.
干预措施: mRNA-1647 (Biological)
Optional Booster Phase - BD Recipients
Participants who opted to enroll into the optional Booster Phase will receive a single mRNA-1647 vaccine dose.
干预措施: mRNA-1647 (Other)
Optional Booster Phase - Observational Group
Participants who opted to enroll into the Observational Group will be followed in the optional BP until BP Month 12.
干预措施: mRNA-1647 (Biological)
结局指标
主要结局
BP: Number of Participants with Solicited Adverse Reactions (ARs)
时间窗: Up to BP Day 7 (7 days after BP vaccination)
BP: Number of Participants with Medically-Attended AEs (MAAEs)
时间窗: Up to BP Month 6 (6 months after BP vaccination)
BP: Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to BP Day 28 (28 days after BP vaccination)
Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)
时间窗: Up to 3 years
BP: GMTs of Antigen-Specific nAb and bAb
时间窗: BP Month 0, BP Month 1, BP Month 3, BP Month 6, and BP Month 12
BP: Number of Participants with Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
时间窗: Up to BP Month 12
次要结局
- Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation(Up to 3 years)
- Primary Extension Phase: Number of Participants With SAEs(Up to 3 years)