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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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05085366
Collaborator
(none)
6,900
Enrollment
129
Locations
2
Arms
45.1
Anticipated Duration (Months)
53.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: mRNA-1647
  • Biological: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 26, 2021
Anticipated Primary Completion Date :
Jan 29, 2023
Anticipated Study Completion Date :
Jul 29, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647 [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) [Up to 176 days (7 days after each injection)]

  3. Number of Participants With Unsolicited Adverse Events (AEs) [Up to 197 days (28 days after each injection)]

  4. Number of Participants With Medically-Attended Adverse Events (MAAEs) [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) [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 [Day 1, Months 3, 7, 12, 18, 24, and 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:

  • Participants aged ≥20 years, has or anticipates having direct exposure (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.

  • Has a body mass index of 15-35 kilograms (kg)/square meter (m^2), inclusive.

  • 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:

  • Female participant is of non-childbearing potential.

  • 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 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.

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MedPharmics, LLC Phoenix Arizona United States 85015-1105
2 Hope Clinical Research, LLC - Hunt Phoenix Arizona United States 85018
3 Hope Research Institute LLC Tempe Arizona United States 85284
4 Noble Clinical Research Tucson Arizona United States 86704
5 Baptist Health Center for Clinical Research Little Rock Arkansas United States 72205-6355
6 Preferred Research Partners Little Rock Arkansas United States 72211
7 Velocity Clinical Research - Banning Banning California United States 92220
8 Velocity Clinical Research - Chula Vista Chula Vista California United States 91911-6617
9 Paradigm Clinical Research Institute, Inc. La Mesa California United States 91942-3189
10 Paradigm Clinical Research Center La Mesa California United States 91942
11 Velocity Clinical Research - San Diego La Mesa California United States 91942
12 Paradigm Clinical Research Institute, Inc. - ClinEdge Redding California United States 96001-0172
13 Bayview Research Group Valley Village California United States 91607
14 Clinical Research Consultants LLC Milford Connecticut United States 06460-4647
15 Precision Clinical Research, LLC Coral Springs Florida United States 33065
16 Universal Axon Clinical Research Doral Florida United States 33166
17 Velocity Clinical Research, New Smyrna Beach Edgewater Florida United States 32132-2720
18 Indago Research and Health Center Hialeah Florida United States 33012-4174
19 Miami Clinical Research Miami Florida United States 33155
20 CVS HealthHub - Atlanta S Atlanta Georgia United States 30311
21 CVS HealthHub - Atlanta Atlanta Georgia United States 30329
22 Tekton Research - Georgia - Platinum Chamblee Georgia United States 30341
23 IACT Health Columbus Georgia United States 31904
24 CVS HealthHub - Dacula Dacula Georgia United States 30019
25 IResearch Atlanta LLC Decatur Georgia United States 30030
26 CVS HealthHub - Kennesaw Kennesaw Georgia United States 30152
27 CVS HealthHub - Mcdonough McDonough Georgia United States 30253
28 CVS HealthHub - Newman Newnan Georgia United States 30265
29 Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS Sandy Springs Georgia United States 30328
30 CVS HealthHub - Savannah Savannah Georgia United States 31405
31 Optimal Research Peoria Illinois United States 61614
32 Johnson Country Clin-Trials Lenexa Kansas United States 66219
33 Alliance for Multispecialty Research, LLC Newton Kansas United States 67114
34 Alliance for Multispecialty Research, LLC Lexington Kentucky United States 40509
35 MedPharmics Metairie Louisiana United States 70006-4151
36 Meridian Clinical Research-(Rockville Maryland) Rockville Maryland United States 20854-2957
37 ActivMed Practices & Research Inc Methuen Massachusetts United States 01844
38 Clinical Research Institute, Inc - CRN - PPDS Minneapolis Minnesota United States 55402-2750
39 University of Minnesota Clinical Research Unit Minneapolis Minnesota United States 55454
40 MedPharmics, LLC Gulfport Mississippi United States 39503
41 MediSync Clinical Research Hattiesburg Clinic Petal Mississippi United States 39465-2932
42 Meridian Clinical Research (Grand Island, Nebraska) Grand Island Nebraska United States 68803-4327
43 Meridian Clinical Research (Hastings, Nebraska) Hastings Nebraska United States 68901-2615
44 Meridian Clinical Research (Norfolk-Nebraska) Norfolk Nebraska United States 68701-2669
45 Quality Clinical Research Omaha Nebraska United States 68114-3755
46 Meridian Clinical Research-(Omaha Nebraska) Omaha Nebraska United States 68134
47 Med Clinic Research Partners, LLC Irvington New Jersey United States 07111
48 Albuquerque Clinical Trials Inc. Albuquerque New Mexico United States 87102-3644
49 MedPharmics, LLC. - Albuquerque Albuquerque New Mexico United States 87102
50 Meridian Clinical Research (Endwell-New York) - Platinum - PPDS Binghamton New York United States 13901-1046
51 Meridian Clinical Research, LLC Binghamton New York United States 13901-1046
52 Rochester Clinical Research, Inc Rochester New York United States 14609-3173
53 OnSite Clinical Solutions, LLC - ClinEdge Charlotte North Carolina United States 28277-4442
54 OnSite Clinical Solutions, LLC Charlotte North Carolina United States 28277
55 Carolina Institute for Clinical Research - M3 WR - ERN - PPDS Fayetteville North Carolina United States 28303
56 Lucas Research Morehead City North Carolina United States 28557
57 M3 Wake Research, Inc - M3 WR - ERN - PPDS Raleigh North Carolina United States 27612
58 Lillestol Research Fargo North Dakota United States 58104
59 CTI Clinical Research Center - ClinEdge - PPDS Cincinnati Ohio United States 45212
60 Meridian Cincinnati Cincinnati Ohio United States 45219-2975
61 ClinOhio Research Services Columbus Ohio United States 43213-4440
62 Aventiv Research Inc. Columbus Ohio United States 43213
63 PriMed Clinical Research - ClinEdge Dayton Ohio United States 45419
64 Senders Pediatrics South Euclid Ohio United States 44121
65 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
66 Tekton Research - Oklahoma - Platinum Yukon Oklahoma United States 73099
67 Coastal Carolina Research Center North Charleston South Carolina United States 29405
68 ARC Clinical Research at Wilson Parke Austin Texas United States 78726-4061
69 Premier Family Physicians - Austin - Hunt Austin Texas United States 78735
70 ARC Clinical Research at William Cannon Austin Texas United States 78745
71 Tekton Research, Inc. Austin Texas United States 78745
72 Tekton Research - Beaumont Beaumont Texas United States 77706-3061
73 Velocity Clinical Research - Austin Cedar Park Texas United States 78613-3936
74 Village Health Partners Frisco Medical Village Frisco Texas United States 75033
75 Vilo Research Group, L.L.C. Houston Texas United States 77017-2338
76 University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program League City Texas United States 77573-1427
77 Synergy Group US, LLC Missouri City Texas United States 77459-4756
78 Austin Regional Clinic ARC Clinical Research at Kelly Lane Pflugerville Texas United States 78660
79 Clinical Trials of Texas, Inc. - HyperCor San Antonio Texas United States 78229-3539
80 Diagnostics Research Group San Antonio Texas United States 78229
81 DM Clinical Research Tomball Texas United States 77375
82 Crossroads Clinical Research (Victoria) Victoria Texas United States 77901
83 Tanner Clinic Layton Utah United States 84041
84 Foothill Family Clinic - South Clinic Salt Lake City Utah United States 84121
85 Velocity Clinical Research - Boise West Jordan Utah United States 84088
86 Health Research of Hampton Roads Inc. - ClinEdge Newport News Virginia United States 23606
87 York Clinical Research Norfolk Virginia United States 23510-2014
88 David Ramstad Associates Research - IACT - HyperCore - PPDS Suffolk Virginia United States 23435
89 Paratus Clinical Research Bruce Australian Capital Territory Australia 2617
90 Paratus Clinical Research - Western Sydney Blacktown New South Wales Australia 2148
91 Northern Beaches Clinical Research Brookvale New South Wales Australia 2100
92 Kanwal Medical Complex Kanwal New South Wales Australia 2259
93 The Kirby Institute Sydney New South Wales Australia 2052
94 University of the Sunshine Coast, Health Hub Morayfield Morayfield Queensland Australia 4506
95 University of the Sunshine Coast Sippy Downs Queensland Australia 4556
96 USC Southbank Southbank Queensland Australia 4101
97 Barwon Health Geelong Victoria Australia 3220
98 Royal Melbourne Hospital Parkville Victoria Australia 3050
99 Telethon Kids Institute Nedlands Western Australia Australia 6009
100 CHU de Liège Liège Belgium B-4000
101 Dr. Anil K. Gupta Medicine Professional Corporation Toronto Ontario Canada M9V 4B4
102 LMC Manna Research - Mirabel - HyperCore - PPDS Mirabel Quebec Canada J7J 2K8
103 LMC Manna Research - Montreal - HyperCore - PPDS Pointe-Claire Quebec Canada H9R 4S3
104 Diex Recherche - Québec - HyperCore Québec City Quebec Canada G1N 4V3
105 Diex Recherche - Joilette - HyperCore - PPDS Saint-Charles-Borromée Quebec Canada J6E 2B4
106 Diex Recherche - Sherbrooke - HyperCore Sherbrooke Quebec Canada J1L 0H8
107 Diex Recherche - Victoriaville - HyperCore Victoriaville Quebec Canada G6P 6P6
108 LMC Manna Research - Quebec - HyperCore - PPDS Levis Canada G6W OM5
109 CCBR Clinical Research Tallinn Harjumaa Estonia 10128
110 Al Mare Family Doctors Centre Tallinn Harjumaa Estonia 10617
111 Merelahe Family Doctors Centre Tallinn Harjumaa Estonia 10617
112 Vee Family Doctors Center Ltd Paide Järvamaa Estonia 72713
113 Clinical Research Centre Ltd. Tartu Tartumaa Estonia 50106
114 Tampereen Yliopisto Seinajoen Rokotusklinikka Seinäjoki Etelä-Pohjanmaa Finland 60100
115 Etelä Helsingin Rokotetutkimusklinikka Helsinki Etelä-Suomen Lään Finland 100
116 Kokkolan Rokotetutkimusklinikka Kokkola Keski-Pohjanmaa Finland 67100
117 Oulun Rokotetutkimusklinikka Oulu Oulun Lääni Finland 90220
118 Tampereen Rokotetutkimusklinikka Tampere Pirkanmaa Finland 33100
119 Porin Rokotetutkimusklinikka Pori Satakunta Finland 28100
120 Espoon rokotetutkimusklinikka Espoo Uusimaa Finland 2230
121 Itä Helsingin Rokotetutkimusklinikka Helsinki Uusimaa Finland 930
122 Järvenpään Rokotetutkimusklinikka Järvenpää Uusimaa Finland 4400
123 Turun Rokotetutkimusklinikka Turku Västra Finlands Län Finland 20520
124 C.H. Regional Reina Sofia Cordoba Andalusia Spain 14004
125 Instituto Hispalense de Pediatria Sevilla Andalusia Spain 41014
126 Hospital Clinic de Barcelona Barcelona Catalonia Spain 8036
127 CHUS - H. Clinico U. de Santiago Santiago de Compostela Galicia Spain 15706
128 Hospital Universitario La Paz. Madrid Spain 28046
129 William Harvey Clinical Research Centre London England United Kingdom EC1M 6BQ

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:
NCT05085366
Other Study ID Numbers:
  • mRNA-1647-P301
  • 2020-006051-17
First Posted:
Oct 20, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
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:
Infections
Cytomegalovirus Infections

Study Results

No Results Posted as of Jun 30, 2022