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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345043
• Other study ID #: VAL-339851-P101
• Status: Completed
• Phase: Phase 1
• Start date: May 11, 2016
• Est. completion date: August 13, 2018

Study information

• Verified date: January 2021
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• VAL-339851
Escalating dose levels

Other:
• Placebo
Saline

Locations

Country	Name	City	State
United States	Miami Research Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of solicited AEs (local and systemic reactogenicity events)		7 days following each dose administration
Primary	Frequency of unsolicited adverse events		21 days following each dose administration
Primary	Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness		One year after last dose administration
Secondary	Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample		One year after last dose administration
Secondary	Seroconversion rates in comparison to baseline samples		One year after last dose administration