Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult Subjects

• ClinicalTrials.gov Identifier: NCT03345043
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Last Update Posted: January 11, 2021
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: November 14, 2017
• First Posted Date: November 17, 2017
• Last Update Posted Date: January 11, 2021
• Actual Study Start Date: May 11, 2016
• Actual Primary Completion Date: August 13, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 14, 2017)

• Frequency of solicited AEs (local and systemic reactogenicity events) [ Time Frame: 7 days following each dose administration ]
• Frequency of unsolicited adverse events [ Time Frame: 21 days following each dose administration ]
• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 14, 2017)

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

• 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-339851 in Healthy Adult Subjects
• 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
• Brief Summary: This clinical study will assess the safety, tolerability and immunogenicity of VAL-339851 in healthy subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Double blind

Primary Purpose: Prevention

• Condition: Influenza

Intervention

• Biological: VAL-339851
  Escalating dose levels
• Other: Placebo
  Saline

Study Arms

• Experimental: VAL-339851
  Intervention: Biological: VAL-339851
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: Feldman RA, Fuhr R, Smolenov I, Mick Ribeiro A, Panther L, Watson M, Senn JJ, Smith M, Almarsson Ӧ, Pujar HS, Laska ME, Thompson J, Zaks T, Ciaramella G. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in healthy adults in phase 1 randomized clinical trials. Vaccine. 2019 May 31;37(25):3326-3334. doi: 10.1016/j.vaccine.2019.04.074. Epub 2019 May 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 14, 2017): 156
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 13, 2018
• Actual Primary Completion Date: August 13, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

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: NCT03345043
• Other Study ID Numbers: VAL-339851-P101
• 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

• Plan to Share IPD: No

• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: January 2021