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A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

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ClinicalTrials.gov Identifier: NCT05085366
Recruitment Status : Active, not recruiting
First Posted : October 20, 2021
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension sub study is to extend the observation period of the main study and to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative females who complete mRNA-1647-P301 main study and to assess for CMV seroconversion in CMV-seronegative participants who did not seroconvert during mRNA-1647-P301 main study. No interventional vaccine will be administered in the extension study.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Biological: mRNA-1647 Biological: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7454 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer-blind
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Actual Study Start Date : October 26, 2021
Estimated Primary Completion Date : April 6, 2026
Estimated Study Completion Date : April 6, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1647
Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.
 Biological: mRNA-1647
Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)
Placebo Comparator: Placebo
Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.
 Biological: Placebo
0.9% sodium chloride (normal saline) injection


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647 [ Time Frame: Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection) ]
  2. Number of Participants With Solicited Adverse Reactions (ARs) [ Time Frame: Up to 176 days (7 days after each injection) ]
  3. Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to 197 days (28 days after each injection) ]
  4. Number of Participants With Medically-Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through 6 months after the last injection (up to 347 days) ]
  5. Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 887 ]
  6. Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) [ Time Frame: Month 30 up to Month 54 ]
  7. Geometric Mean Concentration (GMC) of Binding Antibody [ Time Frame: Month 30 up to Month 54 ]
  8. Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647 [ Time Frame: Day 887 up to Day 1607 ]

Secondary Outcome Measures :
  1. GMTs of Antigen-Specific nAb [ Time Frame: Day 1, Months 3, 7, 12, 18, 24, and 30 ]
  2. GMC of Antigen-Specific Binding Antibody [ Time Frame: Day 1, Months 3, 7, 12, 18, 24, and 30 ]
  3. Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths [ Time Frame: Day 887 through end of study (up to Day 1607) ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Participants aged ≥20 years, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child ≤5 years of age. Direct exposure is defined as either participant is the parent, or participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
  • CMV-seronegative Cohort is CMV-seronegative based on CMV testing at Screening.
  • CMV-seropositive Cohort is CMV-seropositive based on CMV testing at Screening.
  • Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/legally acceptable representative (LAR)(s), as applicable, understand and are willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30 month study period.
  • Female participants of child-bearing potential: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active with men, has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1) and agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257).

Extension substudy:

  • All consenting participants in mRNA-1647-P301 main study who were CMV-seronegative at baseline and did not seroconvert during the main study, received at least one study injection, and completed the final study visit in the main study.
  • Consenting participants in mRNA-1647-P301 main study who were CMV-seronegative at baseline, received all 3 study injections, and completed the final study visit in the main study.

Key Exclusion Criteria:

  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
  • Received or plans to receive any nonstudy vaccine <28 days prior to and after any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
  • Any COVID-19 primary vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
  • COVID-19 vaccines (including any booster dose, regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
  • Influenza vaccines may be administered > 14 days prior to or after any study injection.
  • Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥5 milligrams (mg)/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed. Stable immunomodulator regimens used for managing environmental allergies are allowed.
  • Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of first injection or plans to do so during the course of the study.
  • Previous receipt of an investigational CMV vaccine.
  • Receipt of systemic immunoglobulins or blood products <3 months prior to the day of first injection.
  • Participated in an interventional clinical study <28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
  • Participant has donated ≥450 milliliters (mL) of blood products <28 days prior to Screening.
  • Participant is a member of study team or is an immediate family member or household member of study personnel.

Extension substudy:

  • 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 study 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085366


Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05085366    
Other Study ID Numbers: mRNA-1647-P301
2020-006051-17 ( EudraCT Number )
2023-508820-37-00 ( Other Identifier: EU CTR Number )
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1647
Moderna
Cytomegalovirus
CMV
Cytomegalovirus Vaccine
Cytomegalovirus Infections
 Cytomegalovirus Congenital
Virus Diseases
Infection Viral
DNA Virus Infections
Messenger RNA
Additional relevant MeSH terms:
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Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases