- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014089
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
December 6, 2019 updated by: ModernaTX, Inc.
A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of mRNA 1325 Zika Vaccine in Healthy Adults in a Non-endemic Zika Region
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
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
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California
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San Diego, California, United States, 92108
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Florida
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Melbourne, Florida, United States, 32934
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Illinois
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Peoria, Illinois, United States, 61614
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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
16 years to 47 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion
- 18 to 49 years of age
- Body mass index between 18 and 35 kg/m2
- In good health as determined by medical history
- Female subjects must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically sterile
- Women of childbearing potential must agree to be heterosexually inactive or agree to consistently use any of the following methods of contraception from at least 21 days prior to enrollment and through 3 months after the final vaccination
- Male subjects must use an acceptable method of birth control throughout the entire study and agree to refrain from donation of sperm from the time of first vaccination until 3 months following the last vaccination
- Agrees to comply with the study procedures and provides written informed consent
- Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study, to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
Exclusion
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- A history of active cancer (malignancy) in the last 10 years
- Female of childbearing potential and has a positive pregnancy test at screening or on the day of vaccination
- Administration of an investigational product within 60 days, or 5 half-lives, whichever is longer
- Administration of any live attenuated vaccines within 4 weeks before enrollment or inactive vaccines within 2 weeks before enrollment, or plans to receive any vaccine during the active vaccination period
- Prior administration of a vaccine for Zika or dengue vaccine, a history of confirmed Zika or dengue infection, or has lived in or visited any Zika-endemic area greater than 4 weeks in duration
- Prior administration of investigational agent using formulations similar to mRNA-1325
- A history of hypersensitivity or serious reactions to previous vaccinations
- Any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination
- A history of inflammatory arthritis
- Any neurologic disorder
- A history of febrile disease with arthritis or arthralgia within 2 weeks of dose administration.
- Prior administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study drug or plans to receive such products at any time during the study
- Any chronic administration of an immunosuppressant or other immune modifying drug
- Any acute illness at the time of enrollment
- Any significant disorder of coagulation requiring ongoing or intermittent treatment
- A history of idiopathic urticaria
- A history of alcohol abuse or drug addiction
- A positive test result for drugs of abuse
- The subject has any abnormality or permanent body art (eg, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
- 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
- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
- Donation of blood or blood products > 450 mL within 30 days of dosing.
- Abnormal vital signs or screening safety laboratory test results including liver enzyme tests
- Is an employee or first degree relative of the Sponsor, CRO, or study site personnel
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
0.9% sodium chloride
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Experimental: mRNA-1325
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Escalating dose levels
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI) and adverse events considered related to study drug
Time Frame: Through 13 months of study participation
|
Through 13 months of study participation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample
Time Frame: Through 13 months of study participation
|
Through 13 months of study participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
December 21, 2016
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
January 5, 2017
First Submitted That Met QC Criteria
January 5, 2017
First Posted (Estimate)
January 9, 2017
Study Record Updates
Last Update Posted (Actual)
December 9, 2019
Last Update Submitted That Met QC Criteria
December 6, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mRNA-1325-P101
- HHSO100201600029C (Other Grant/Funding Number: BARDA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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