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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085366
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6900 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 : January 29, 2023
Estimated Study Completion Date : July 29, 2025


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




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 end of study (up to Day 887) ]

Secondary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody [ Time Frame: Day 1, Months 3, 7, 12, 18, 24, and 30 ]


Information from the National Library of Medicine

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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: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active, has practiced adequate contraception 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).

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 Coronavirus disease 2019 (COVID-19) vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
  • COVID-19 vaccines (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.

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


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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Sponsors and Collaborators
ModernaTX, Inc.
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 )
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022

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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.:
Moderna
mRNA-1647
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