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Safety, Tolerability, and Immunogenicity of VAL-339851 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: NCT03345043
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.

Condition or disease Intervention/treatment Phase
Influenza Biological: VAL-339851 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VAL-339851 in Healthy Subjects
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: VAL-339851 Biological: VAL-339851
Escalating dose levels

Placebo Comparator: Placebo Other: Placebo
Saline




Primary Outcome Measures :
  1. Frequency of solicited AEs (local and systemic reactogenicity events) [ Time Frame: 7 days following each dose administration ]
  2. Frequency of unsolicited adverse events [ Time Frame: 21 days following each dose administration ]
  3. Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness [ Time Frame: One year after last dose administration ]

Secondary Outcome Measures :
  1. Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample [ Time Frame: One year after last dose administration ]
  2. Seroconversion rates in comparison to baseline samples [ Time Frame: One year after last dose administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Agrees to comply with the study procedures and provides written informed consent
  • 18 to 49 years of age
  • Body mass index between 18 and 35 kg/m2
  • Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential.
  • Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 3 weeks prior to enrollment and through the end of study visit
  • In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
  • 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
  • Administration of another investigational product within 60 days, or 5 half-lives, whichever is longer
  • Participation in an investigational study involving lipid nanoparticles
  • A history of hypersensitivity or serious reactions to previous influenza vaccinations
  • History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine
  • History of narcolepsy
  • Administration of any licensed (inactivated or live) vaccines within 4 weeks before enrollment or plans to receive any vaccine within 12 weeks of the last study drug administration; receipt of any other avian H7N9 influenza vaccine at any time prior to or during the study is exclusionary
  • 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 significant disorder of coagulation requiring ongoing or intermittent treatment
  • Active neoplastic disease or a history of any hematologic malignancy
  • History of alcohol abuse or drug addiction within 1 year before the planned day of dose administration
  • A positive test result for drugs of abuse or alcohol at screening or before the first dose administration
  • Persons employed in a capacity that involves handling poultry or wild birds.
  • 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 vaccine or interpretation of the study results
  • A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening
  • Donation of blood or blood products > 450 mL within 30 days of dosing

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): NCT03345043


Locations
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United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
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: NCT03345043    
Other Study ID Numbers: VAL-339851-P101
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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-339851
H7N9 antigen mRNA
Influenza vaccine
Moderna
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases