Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03325075
• Recruitment Status: Completed
• First Posted: October 30, 2017
• Last Update Posted: January 21, 2020
• Sponsor: ModernaTX, Inc.
• Collaborator: Defense Advanced Research Projects Agency
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: October 20, 2017
• First Posted Date: October 30, 2017
• Last Update Posted Date: January 21, 2020
• Actual Study Start Date: August 15, 2017
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2017)

• Types of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [ Time Frame: Through 13 months of study participation ]
• Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [ Time Frame: Through 13 months of study participation ]
• Severity of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [ Time Frame: Through 13 months of study participation ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 24, 2017): Frequency of seroconversion to CHIKV measured by neutralization assay in comparison with baseline [ Time Frame: Through 13 months of study participation ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects
• Official Title: A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of VAL-181388 in Healthy Adults in a Non Endemic Chikungunya Region
• Brief Summary: This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Double Blind

Primary Purpose: Prevention

• Condition: Chikungunya Virus

Intervention

• Biological: VAL-181388
  Escalating dose levels
• Other: Placebo
  Saline

Study Arms

• Experimental: VAL-181388
  Intervention: Biological: VAL-181388
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 24, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 1, 2019
• Actual Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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, or c) of childbearing potential and agree to use an adequate contraception method
• Male subjects must use an acceptable method of birth control through 3 months after the final 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

Exclusion Criteria:

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
• Female of childbearing potential and has a positive pregnancy test at screening or on the day of vaccination
• Abnormal vital signs or screening safety laboratory test results including liver enzyme tests
• 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 CHIKV, dengue, Yellow Fever, tick-borne encephalitis, a history of confirmed or suspected CHIKV infection, or has lived in a CHIKV-endemic area greater than 1 year or cumulative stay of greater than 30 days in 5 years
• Prior administration of investigational agent using formulations similar to VAL-181388
• 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
• 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
• Daily or every other day administration of antipyretic or analgesic medication
• 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
• A history of active cancer (malignancy) in the last 10 years
• Donation of blood or blood products > 450 mL within 30 days of dosing
• Is an employee or first degree relative of the Sponsor, CRO, or study site personnel

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03325075
• Other Study ID Numbers: VAL-181388-P101; W911NF-13-1-0417 ( Other Grant/Funding Number: Defense Advanced Research Projects Agency (DARPA) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Defense Advanced Research Projects Agency
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: January 2020