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

Primary Purpose

Zika Virus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1325
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zika Virus focused on measuring mRNA-1325, Zika vaccine

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mRNA-1325

Placebo

Arm Description

0.9% sodium chloride

Outcomes

Primary Outcome Measures

Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI) and adverse events considered related to study drug

Secondary Outcome Measures

Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample

Full Information

First Posted
January 5, 2017
Last Updated
December 6, 2019
Sponsor
ModernaTX, Inc.
Collaborators
Biomedical Advanced Research and Development Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03014089
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2016 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
Collaborators
Biomedical Advanced Research and Development Authority

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus
Keywords
mRNA-1325, Zika vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1325
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride
Intervention Type
Biological
Intervention Name(s)
mRNA-1325
Intervention Description
Escalating dose levels
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Frequency of seroconversion to ZIKV measured by neutralization assay in comparison with baseline sample
Time Frame
Through 13 months of study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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