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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05085366




Registration number
NCT05085366
Ethics application status
Date submitted
7/10/2021
Date registered
20/10/2021
Date last updated
24/04/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Scientific 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
Secondary ID [1] 0 0
2020-006051-17
Secondary ID [2] 0 0
mRNA-1647-P301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - mRNA-1647
Treatment: Other - Placebo

Experimental: mRNA-1647 - Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 1, Day 57, and Day 169.

Placebo comparator: Placebo - Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 1, Day 57, and Day 169.


Treatment: Other: mRNA-1647
Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)

Treatment: Other: Placebo
0.9% sodium chloride (normal saline) injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647
Timepoint [1] 0 0
Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)
Primary outcome [2] 0 0
Number of Participants With Solicited Adverse Reactions (ARs)
Timepoint [2] 0 0
Up to 176 days (7 days after each injection)
Primary outcome [3] 0 0
Number of Participants With Unsolicited Adverse Events (AEs)
Timepoint [3] 0 0
Up to 197 days (28 days after each injection)
Primary outcome [4] 0 0
Number of Participants With Medically-Attended Adverse Events (MAAEs)
Timepoint [4] 0 0
Day 1 through 6 months after the last injection (up to 347 days)
Primary outcome [5] 0 0
Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Day 1 through Day 887
Primary outcome [6] 0 0
Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb)
Timepoint [6] 0 0
Month 30 up to Month 54
Primary outcome [7] 0 0
Geometric Mean Concentration (GMC) of Binding Antibody
Timepoint [7] 0 0
Month 30 up to Month 54
Primary outcome [8] 0 0
Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647
Timepoint [8] 0 0
Day 887 up to Day 1607
Secondary outcome [1] 0 0
GMTs of Antigen-Specific nAb
Timepoint [1] 0 0
Day 1, Months 3, 7, 12, 18, 24, and 30
Secondary outcome [2] 0 0
GMC of Antigen-Specific Binding Antibody
Timepoint [2] 0 0
Day 1, Months 3, 7, 12, 18, 24, and 30
Secondary outcome [3] 0 0
Number of Participants with AEs leading to Study Discontinuation, SAEs and Deaths
Timepoint [3] 0 0
Day 887 through end of study (up to Day 1607)

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
16 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/04/2026
Actual
Sample size
Target
Accrual to date
Final
7454
Recruitment in Australia
Recruitment state(s)
ACT,NSW,North South WalesQLD,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research - Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [4] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [5] 0 0
Kanwal Medical Complex - Kanwal
Recruitment hospital [6] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [7] 0 0
Emeritus Research - Botany
Recruitment hospital [8] 0 0
University of the Sunshine Coast, Health Hub Morayfield - Morayfield
Recruitment hospital [9] 0 0
University of the Sunshine Coast - Sippy Downs
Recruitment hospital [10] 0 0
USC Southbank - Southbank
Recruitment hospital [11] 0 0
Emeritus Research - Camberwell
Recruitment hospital [12] 0 0
Barwon Health - Geelong
Recruitment hospital [13] 0 0
The University of Melbourne - Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Telethon Kids Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2100 - Brookvale
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2259 - Kanwal
Recruitment postcode(s) [6] 0 0
2291 - Merewether
Recruitment postcode(s) [7] 0 0
02019 - Botany
Recruitment postcode(s) [8] 0 0
4506 - Morayfield
Recruitment postcode(s) [9] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [10] 0 0
4101 - Southbank
Recruitment postcode(s) [11] 0 0
03124 - Camberwell
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3000 - Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Liège
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München
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Weinheim
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Israel
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Central District Of Israel
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Israel
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Haifa Hefa
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Israel
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Rishon Lezion
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Israel
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Tel Aviv District
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Israel
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Yerushalayim Al Quds
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Israel
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Kfar Saba
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Israel
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Petah-Tikva
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Israel
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Tel-Aviv
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Italy
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Genova
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Italy
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Monza
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyôgo
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Japan
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Kansai
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Spain
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Andalusia
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Spain
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Catalonia
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Spain
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Galicia
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Spain
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Madrird
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Spain
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Madrid
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United Kingdom
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Cleveland
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England
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Northamptonshire
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Northumberland
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South West England
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ModernaTX, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05085366
Trial related presentations / publications
Kadambari S, Evans C, Lyall H. Congenital Infections: Priorities and Possibilities for Resource-limited Settings. Pediatr Infect Dis J. 2023 Feb 1;42(2):e45-e47. doi: 10.1097/INF.0000000000003710. Epub 2022 Sep 12. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05085366