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Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy 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: NCT03325075
Recruitment Status : Active, not recruiting
First Posted : October 30, 2017
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Defense Advanced Research Projects Agency
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy subjects.

Condition or disease Intervention/treatment Phase
Chikungunya Virus Biological: VAL-181388 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Prevention
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
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Experimental: VAL-181388 Biological: VAL-181388
Escalating dose levels

Placebo Comparator: Placebo Other: Placebo
Saline




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325075


Locations
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United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
ModernaTX, Inc.
Defense Advanced Research Projects Agency

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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT03325075     History of Changes
Other Study ID Numbers: VAL-181388-P101
W911NF-13-1-0417 ( Other Grant/Funding Number: Defense Advanced Research Projects Agency (DARPA) )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
VAL-181388
Chikungunya vaccine
Additional relevant MeSH terms:
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Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases