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History of Changes for Study: NCT03014089
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
Latest version (submitted December 6, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 5, 2017 None (earliest Version on record)
2 February 13, 2017 Study Status and Contacts/Locations
3 October 17, 2017 Contacts/Locations and Study Status
4 January 22, 2018 Recruitment Status, Study Status and Contacts/Locations
5 October 30, 2018 Study Status, Study Design and Study Identification
6 March 29, 2019 Study Status
7 April 24, 2019 Study Status
8 July 1, 2019 Recruitment Status, Study Status and Study Design
9 December 6, 2019 Study Status
Comparison Format:

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Study NCT03014089
Submitted Date:  October 30, 2018 (v5)

Open or close this module Study Identification
Unique Protocol ID: mRNA-1325-P101
Brief Title: Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
Official Title: 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
Secondary IDs: HHSO100201600029C [Other Grant/Funding Number: Biomedical Advanced Research & Development Authority (BARDA)]
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Active, not recruiting
Study Start: December 2016
Primary Completion: February 2019 [Anticipated]
Study Completion: February 2019 [Anticipated]
First Submitted: January 5, 2017
First Submitted that
Met QC Criteria:
January 5, 2017
First Posted: January 9, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 30, 2018
Last Update Posted: November 1, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators: Biomedical Advanced Research and Development Authority
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
Detailed Description:
Open or close this module Conditions
Conditions: Zika Virus
Keywords: mRNA-1325
Zika vaccine
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: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: mRNA-1325 Biological: mRNA-1325
Escalating dose levels
Placebo Comparator: Placebo
0.9% sodium chloride
Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

Secondary Outcome Measures:
1. Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample
[ Time Frame: Through 13 months of study participation ]

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

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
Open or close this module Contacts/Locations
Locations: United States, California
San Diego, California, United States, 92108
United States, Florida
Melbourne, Florida, United States, 32934
United States, Illinois
Peoria, Illinois, United States, 61614
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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