- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03382405
Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
January 13, 2021 updated by: ModernaTX, Inc.
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
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Hollywood, Florida, United States, 33024
- Research Centers of America
-
-
Idaho
-
Meridian, Idaho, United States, 83642
- Advanced Clinical Research
-
-
Illinois
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Peoria, Illinois, United States, 61614
- Optimal Research
-
-
Kansas
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Lenexa, Kansas, United States, 66219
- Johnson County Clinical Trials
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- Male subjects must agree to practice adequate contraception for 30 days prior to the first vaccination and through 3 months following the 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
- A history of seizure disorder for which anticonvulsants are currently prescribed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Saline
|
Experimental: mRNA-1647
|
Escalating dose levels
|
Experimental: mRNA-1443
|
Escalating dose levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of solicited AEs (local and systemic reactogenicity events)
Time Frame: 7 days following each dose administration
|
7 days following each dose administration
|
Frequency of unsolicited adverse events
Time Frame: 29 days following each dose administration
|
29 days following each dose administration
|
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
|
one year following the last dose administration
|
Frequency of clinical laboratory adverse events
Time Frame: 1 month following the last dose administration
|
1 month following the last dose administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 months following the last dose administration
|
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
|
6 months following the last dose administration
|
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
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6 months following the last dose administration
|
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
|
6 months following the last dose administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2017
Primary Completion (Actual)
October 28, 2020
Study Completion (Actual)
October 28, 2020
Study Registration Dates
First Submitted
December 6, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Actual)
January 15, 2021
Last Update Submitted That Met QC Criteria
January 13, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mRNA-1647/mRNA-1443-P101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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