Clinical trial NCT04975893: A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Cytomegalovirus Infection
Keywords: Moderna
mRNA-1647
Cytomegalovirus
CMV
Cytomegalovirus Vaccine
Cytomegalovirus Infections
Cytomegalovirus Congenital
Virus Diseases
Infection Viral
DNA Virus Infections
Messenger RNA
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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-P202.
* 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.

Exclusion Criteria:

Primary Extension Phase:

* Receipt of any CMV vaccine other than mRNA-1647.
* 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-P202.

For Observational Group:

- Participants from the placebo or mRNA-1647 medium dose groups in study mRNA-1647-P202.

Note: Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)
timeFrame: Up to 3 years
measure: BP: GMTs of Antigen-Specific nAb and bAb
timeFrame: BP Month 0, BP Month 1, BP Month 3, BP Month 6, and BP Month 12
measure: BP: Number of Participants with Solicited Adverse Reactions (ARs)
timeFrame: Up to BP Day 7 (7 days after BP vaccination)
measure: BP: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to BP Day 28 (28 days after BP vaccination)
measure: BP: Number of Participants with Medically-Attended AEs (MAAEs)
timeFrame: Up to BP Month 6 (6 months after BP vaccination)
measure: BP: Number of Participants with Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
timeFrame: Up to BP Month 12
Secondary outcomes:
measure: Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation
timeFrame: Up to 3 years
measure: Primary Extension Phase: Number of Participants With SAEs
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Optimal Research, LLC
state: Illinois
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc.
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispeciality Research, LLC
state: Kentucky
city: Austin
country: United States
facility: Tekton Research Inc
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research (Victoria)
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
Study officials:
References: