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Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014089
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date December 9, 2019
Study Start Date  ICMJE December 21, 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample [ Time Frame: Through 13 months of study participation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
Official Title  ICMJE 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
Brief Summary The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Zika Virus
Intervention  ICMJE
  • Biological: mRNA-1325
    Escalating dose levels
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: mRNA-1325
    Intervention: Biological: mRNA-1325
  • Placebo Comparator: Placebo
    0.9% sodium chloride
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014089
Other Study ID Numbers  ICMJE mRNA-1325-P101
HHSO100201600029C ( Other Grant/Funding Number: Biomedical Advanced Research & Development Authority (BARDA) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Biomedical Advanced Research and Development Authority
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP