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A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05575492
Collaborator
(none)
770
Enrollment
61
Locations
5
Arms
31.7
Anticipated Duration (Months)
12.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition,mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.

Condition or Disease Intervention/Treatment Phase
  • Biological: mRNA-1647
  • Other: Placebo
 Phase 1/Phase 2

Detailed Description

The study will be conducted in 2 parts: Part A Dose-Ranging and Part B Safety Expansion.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
770 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Part A: Dose-escalating, non-randomized Part B: RandomizedPart A: Dose-escalating, non-randomized Part B: Randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part A of this study will be open-label and blinding is not applicable. Part B of the study will be observer-blinded.
Primary Purpose:
Prevention
Official Title:
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
Actual Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: mRNA-1647 Dose A

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level A by intramascular (IM) injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Biological: mRNA-1647
Sterile liquid for injection
Experimental: mRNA-1647 Dose B

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level B by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Biological: mRNA-1647
Sterile liquid for injection
Experimental: mRNA-1647 Dose C

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age and 16 to 25 years of age will receive mRNA-1647 at Dose Level C by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Biological: mRNA-1647
Sterile liquid for injection
Experimental: Dose Expansion: mRNA-1647

CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Biological: mRNA-1647
Sterile liquid for injection
Placebo Comparator: Dose Expansion: Placebo

Participants will receive placebo by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6.

Other: Placebo
0.9% sodium chloride injection (normal saline)

Outcome Measures

Primary Outcome Measures

  1. Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [Up to Day 176 (7 days after the last study injection)]

  2. Number of Unsolicited Adverse Events (AEs) [Up to Day 197 (28 days after the last study injection)]

  3. Number of Medically Attended Adverse Events (MAAEs) [Up to Day 347 (6 months after the last study injection)]

  4. Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation [Up to Day 527 (end of study)]

  5. Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs) [Up to Day 527 (end of study)]

    Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.

  6. Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs [Up to Day 527 (end of study)]

    Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection..

  7. Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies [Up to Day 527 (end of study)]

    Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection.

Secondary Outcome Measures

  1. GMT of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG [Up to Day 527 (end of study)]

    Serum antigen-specific binding antibody titers against vaccine antigens will be measured by enzyme-linked immunosorbent assay (ELISA) specific to the gB and pentamer proteins.

  2. Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG [Up to Day 527 (end of study)]

    Serum antigen-specific binding antibody titers against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.

  3. GMFR of Binding Anti-gB and Anti-pentamer Specific IgG [Up to Day 527 (end of study)]

    Serum antigen-specific binding antibody titers against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins.

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:

  • Is a female or male 9 to 15 years of age or is a female 16 to 25 years of age at the time of consent.

  • Is in good general health, in the opinion of the Investigator, and is capable of complying with study procedures.

  • For the CMV-seronegative cohorts: At the Screening visit, is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative.

  • For CMV-seropositive cohorts: At the Screening visit, is CMV IgG-positive and CMV IgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMV IgM-indeterminate. Participants with an isolated positive or indeterminate result for CMV IgM (that is, CMV IgG-negative and either CMV IgM-positive or CMV IgM-indeterminate) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV screening.

  • Has a body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards. If 16 to 25 years of age: Has a BMI of 15 to 35 kilograms (kg)/square meter (m^2)

  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 3 months following vaccine administration.

  • If applicable, sexually active male participants of reproductive potential must agree to consistently use a adequate contraception from the time of first study injection through 3 months after the participant's final study injection.

Key Exclusion Criteria:

  • Has a history of a diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.

  • Has received, or plans to receive, any nonstudy vaccine <28 days prior to or after any study injection.

  • Has elevated liver function tests, defined as aspartate aminotransferase , alanine aminotransferase, or elevated creatinine or reduced platelets, with a toxicity score of Grade ≥1 at Screening.

  • Has results of Screening laboratory test (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥1.

  • Is acutely ill or febrile (body temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) at the Screening Visit.

  • Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥10 mg/day prednisone equivalent).

  • Has received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of the first study injection (Day 1) or plans to do so during the course of the study.

  • Reports a history of myocarditis, pericarditis, or myopericarditis.

  • Has reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV 1 or 2 antibodies.

  • Has previously received an investigational CMV vaccine.

  • Has received systemic immunoglobulins or blood products <3 months prior to the day of the first study injection (Day 1).

  • Has donated ≥ 450 milliliter (mL) of blood products <28 days prior to the day of the first study injection (Day 1).

  • Has participated in an interventional clinical study <28 days prior to the day of the first study injection (Day 1) or plans to do so while enrolled in the study.

Note: Other inclusion and exclusion criteria may apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paradigm Clinical Research Institute Inc - ClinEdge - PPDS La Mesa California United States 91942-3189
2 Velocity Clinical Research - San Diego - PPDS La Mesa California United States 91942
3 Tekton Research - Fort Collins - Platinum - PPDS Fort Collins Colorado United States 80525-5752
4 Meridian Clinical Research, LLC - Washington - Platinum - PPDS Washington District of Columbia United States 20016
5 Prohealth Research Center Doral Florida United States 33166-6613
6 Clinical Neuroscience Solutions Inc (Jacksonville-Belfort Rd) Jacksonville Florida United States 32256-6040
7 Clinical Neurosciences Solutions Inc. (Orlando-East South St) Orlando Florida United States 32801-2987
8 Palm Harbor Dermatology Tampa Florida United States 33609-2230
9 Santos Research Center Tampa Florida United States 33615-3219
10 Children's Healthcare of Atlanta Atlanta Georgia United States 30322-1014
11 Tekton Research - Georgia - Platinum - PPDS Chamblee Georgia United States 30341
12 IACT Health - Roswell - IACT - HyperCore - PPDS Columbus Georgia United States 31904-8946
13 iResearch Atlanta - CenExel - PPDS Decatur Georgia United States 30030-3438
14 Clinical Research Prime - ClinEdge - PPDS Idaho Falls Idaho United States 83404-5305
15 Tulane Medical Center New Orleans Louisiana United States 70112-2632
16 University of Maryland School of Medicine Baltimore Maryland United States 21201-1509
17 The Pediatric Centre of Frederick Frederick Maryland United States 21702
18 Wayne State University Detroit Michigan United States 48201
19 Alliance for Multispecialty Research - Kansas City Kansas City Missouri United States 64114-4859
20 Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS Lincoln Nebraska United States 68510
21 Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS Norfolk Nebraska United States 68701-7701
22 Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS Omaha Nebraska United States 68134-3664
23 Adekunle Adeoti LLC East Orange New Jersey United States 07018-2012
24 Albuquerque Clinical Trials Inc - Clinedge - PPDS Albuquerque New Mexico United States 87102-2619
25 MedPharmics, LLC. - Albuquerque - Platinum - PPDS Albuquerque New Mexico United States 87102-3644
26 Rochester Clinical Research, Inc Rochester New York United States 14609-3173
27 Stony Brook University Medical Center Stony Brook New York United States 11794-0001
28 Child Healthcare Associates - East Syracuse Syracuse New York United States 13210-2306
29 OnSite Clinical Solutions, LLC - ClinEdge - PPDS Charlotte North Carolina United States 28277-4859
30 Lucas Research - Morehead City - HyperCore - PPDS Morehead City North Carolina United States 28557-3126
31 Lynn Institute of Norman - ERN - PPDS Norman Oklahoma United States 73072-3251
32 Velocity Clinical Research - Medford - PPDS Medford Oregon United States 97504-7738
33 Coastal Carolina Research Center - PPDS North Charleston South Carolina United States 29405
34 Meharry Medical College Nashville Tennessee United States 37208
35 Tekton Research - Beaumont - Platinum - PPDS Beaumont Texas United States 77706-3061
36 3rd Coast Research Associates Corpus Christi Texas United States 78414-4106
37 BRCR Global Texas Edinburg Texas United States 78539
38 Baylor College of Medicine Houston Texas United States 77030-3411
39 Biopharma Informatic, LLC Houston Texas United States 77043-2737
40 West Houston Clinical Research - Hunt - PPDS Houston Texas United States 77055-1626
41 Victoria Clinical Research Group Port Lavaca Texas United States 77979
42 Tekton Research - Texas - Platinum - PPDS San Antonio Texas United States 78229
43 JBR Clinical Research - CenExel JBR - PPDS Salt Lake City Utah United States 84107-4536
44 Alliance for Multispecialty Research, LLC - Norfolk Norfolk Virginia United States 23502-3932
45 MultiCare Institute for Research and Innovation Spokane Washington United States 99204-2803
46 University Of Wisconsin - Madison Madison Wisconsin United States 53792-0001
47 M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary Calgary Canada
48 Medicentres Canada Incorporated Edmonton Canada
49 Canadian Center for Vaccinology Halifax Canada
50 Hamilton Medical Research Group Hamilton Canada
51 Centre Hospitalier Universitaire Sainte-Justine Montreal Canada
52 CARe Clinic Red Deer Canada
53 Bluewater Clinical Research Group Sarnia Canada
54 Queen Elizabeth Hospital Birmingham United Kingdom
55 Addenbrooke's Hospital Cambridge United Kingdom
56 Noah's Ark Children's Hospital for Wales Cardiff United Kingdom
57 Lakeside Healthcare Corby United Kingdom
58 St. George Hospital London United Kingdom
59 Manchester Royal Infirmary - PPDS Manchester United Kingdom
60 Sheffield Children's Hospital Sheffield United Kingdom
61 Southampton General Hospital Southampton United Kingdom

Sponsors and Collaborators

  • ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ModernaTX, Inc.
ClinicalTrials.gov Identifier:
NCT05575492
Other Study ID Numbers:
  • mRNA-1647-P104
  • 2022-001545-20
First Posted:
Oct 12, 2022
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
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 Vaccine
CMV
Moderna

Study Results

No Results Posted as of Jan 13, 2023