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

NCT ID: NCT03345043

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-11
• Study Completion Date: 2018-08-13

Brief Summary

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

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

VAL-339851

Group Type: EXPERIMENTAL

VAL-339851

Intervention Type: BIOLOGICAL

Escalating dose levels

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline

Interventions

VAL-339851

Escalating dose levels

Intervention Type: BIOLOGICAL

Placebo

Saline

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Miami Research Associates

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31079849 (View on PubMed)

Other Identifiers

VAL-339851-P101

Identifier Type: -

Identifier Source: org_study_id