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History of Changes for Study: NCT03382405
Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
Latest version (submitted January 13, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 18, 2017 None (earliest Version on record)
2 January 31, 2019 Contacts/Locations, Study Status, Eligibility and Study Design
3 March 25, 2019 Contacts/Locations and Study Status
4 August 27, 2019 Recruitment Status, Study Status, Contacts/Locations, Study Design and Conditions
5 January 13, 2021 Recruitment Status and Study Status
Comparison Format:

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Study NCT03382405
Submitted Date:  December 18, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: mRNA-1647/mRNA-1443-P101
Brief Title: Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
Official Title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2017
Overall Status: Recruiting
Study Start: November 13, 2017
Primary Completion: February 2020 [Anticipated]
Study Completion: June 2020 [Anticipated]
First Submitted: December 6, 2017
First Submitted that
Met QC Criteria:
December 18, 2017
First Posted: December 22, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
December 18, 2017
Last Update Posted: December 22, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
Detailed Description:
Open or close this module Conditions
Conditions: Cytomegalovirus Infection
Keywords: cytomegalovirus vaccine
mRNA-1647
mRNA-1443
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 209 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: mRNA-1647 Biological: mRNA-1647
Escalating dose levels
Experimental: mRNA-1443 Biological: mRNA-1443
Escalating dose levels
Placebo Comparator: Placebo
Placebo
Saline
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Frequency of solicited AEs (local and systemic reactogenicity events)
[ Time Frame: 7 days following each dose administration ]

2. Frequency of unsolicited adverse events
[ Time Frame: 29 days following each dose administration ]

3. Frequency of medically-attended AEs, adverse events of special interest (AESI), and serious adverse events (SAE)
[ Time Frame: one year following the last dose administration ]

4. Frequency of clinical laboratory adverse events
[ Time Frame: 1 month following the last dose administration ]

Secondary Outcome Measures:
1. Titers of anti-CMV neutralizing antibodies against epithelial cell infection measured by neutralization assay in comparison with baseline sample
[ Time Frame: 6 months following the last dose administration ]

2. Titers of anti-CMV neutralizing antibodies against fibroblast cell infection measured by neutralization assay in comparison with baseline sample
[ Time Frame: 6 months following the last dose administration ]

3. Titers of vaccine antigen-specific IgG antibodies as measured by ELISA assay in comparison with baseline sample
[ Time Frame: 6 months following the last dose administration ]

4. Frequencies of vaccine antigen-specific CD4 and CD8 T cells secreting interferon gamma as determined by ELISPOT
[ Time Frame: 6 months following the last dose administration ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 49 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Agrees to comply with the study procedures and provides written informed consent
  • 18 to 49 years of age
  • Body mass index between 18 and 35 kg/m2
  • In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
  • Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential
  • Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 30 days prior to enrollment and through 3 months following last vaccination
  • Willing to comply with the requirements of the protocol (eg, complete Diary Cards, return for follow-up visits, be available for safety phone calls)

Exclusion Criteria:

  • Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
  • A history of malignancy in the last 10 years
  • If female and of childbearing potential, is pregnant or lactating, has not adhered to an adequate contraception method from at least 30 days before study entry, or does not plan to do so for at least 3 months after the last vaccination.
  • Abnormal screening safety laboratory test results including liver enzyme tests
  • Administration of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine or has plans for administration during the study period
  • Prior administration of investigational agent using lipid nanoparticle formulations
  • A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
  • A positive test result for drugs of abuse
  • Chronic administration of potentially hepatotoxic drugs or have other medical conditions that affect the liver (eg, alcohol abuse)
  • A history of idiopathic urticaria
  • Plans for administration or has been administered a vaccine within the period from 30 days before through 30 days after each study vaccination, with the exception of any licensed influenza vaccine administered ≥15 days before or after any study vaccination
  • Any chronic administration of an immunosuppressant or other immune modifying drug
  • Prior administration of immunoglobulins and/or any blood products within the 3 months before the first study vaccine or has plans for administration during the study period
  • Any known or suspected immune-mediated disease or immunosuppressive condition as determined by medical history and/or physical examination
  • A history of hypersensitivity or serious reactions to previous vaccinations
  • Any bleeding disorder considered a contraindication to IM injection or blood draw
  • Any acute illness or fever at screening
  • Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study drug or interpretation of study results
  • Dose-escalation phase only, is seropositive for CMV at the Screening visit
  • Donation of blood or blood products > 450 mL within 30 days of dosing.
  • Is an immediate family member or household member of study personnel
Open or close this module Contacts/Locations
Central Contact Person: Moderna Clinical Trials
Telephone: 855-663-6762
Email: clinicaltrials@modernatx.com
Locations: United States, Illinois
Optimal Research
[Recruiting]
Peoria, Illinois, United States, 61614
Contact:Contact: 309-672-1910
United States, Kansas
Johnson County Clinical Trials
[Recruiting]
Lenexa, Kansas, United States, 66219
Contact:Contact: 913-825-4400
United States, Maryland
Optimal Research ), tel:
[Not yet recruiting]
Rockville, Maryland, United States, 20850
Contact:Contact: 301-309-8610
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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