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Safety, Tolerability, and Immunogenicity of VAL-506440 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: NCT03076385
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Influenza Biological: VAL-506440 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects
Study Start Date : December 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: VAL-506440 Biological: VAL-506440
Escalating dose levels

Placebo Comparator: Placebo Other: Placebo



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 hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples [ Time Frame: Through 13 months of study participation ]
  2. Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples [ 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 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion

  • Agrees to comply with the study procedures and provides written informed consent
  • 18 to 64 years of age
  • Body mass index between 18 and 30 kg/m2
  • Negative urine pregnancy test at the Screening visit and the day of each vaccination.
  • Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination
  • In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination

Exclusion

  • Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
  • Administration of an investigational product within 45 days
  • Women who are pregnant or breastfeeding, or plan to become pregnant during the study
  • Prior administration of investigational agent using formulations similar to VAL-506440
  • History of a serious reaction to prior influenza vaccinations
  • History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
  • Administration of any live attenuated vaccines within 4 weeks before enrollment, inactive vaccines within 2 weeks before enrollment, or plans to any vaccine within the vaccination period
  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination
  • Any chronic administration of immunosuppressant or other immune-modifying drugs within 6 months prior to administration of study vaccine
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • Any acute disease at the time of enrollment
  • Any bleeding risk or thromboembolic event or any related medical history
  • Regular alcohol consumption > 3 units/day, or current user of any illicit drugs, or has a history of drug/alcohol abuse with 1 year of screening or has a positive urine drug/alcohol test at screening
  • Persons employed in a capacity that involves handling poultry or wild birds
  • Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies within 4 weeks before administration of the first vaccination, throughout the study
  • Had major surgery or donation of blood or blood products within 4 weeks of dosing
  • Current smoking of more than 10 cigarettes (or equivalent amount of tobacco) per day, and within 3 months prior to Screening
  • Subject is an employee of the Sponsor or CRO involved in the study.
  • Vulnerable subjects (e.g., a subject kept in detention).
  • 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 vaccine or interpretation of the study results
  • History of autoimmune disease
  • Inadequate Liver Function as defined by AST, ALT, GGT, alkaline phosphatase and bilirubin > 1.5xULN
  • Known allergy or history of anaphylaxis or other serious adverse reactions to any of the constituents of the study vaccine

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): NCT03076385


Locations
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Germany
Berlin, Germany
Sponsors and Collaborators
ModernaTX, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT03076385     History of Changes
Other Study ID Numbers: VAL-506440-P101
2015-003452-48 ( EudraCT Number )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ModernaTX, Inc.:
VAL-506440
H10N8 antigen mRNA
Influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases