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

• Sponsor: ModernaTX, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03345043
• Collaborator: (none)
• Enrollment: 156
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.1
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 11, 2016
• Actual Primary Completion Date: Aug 13, 2018
• Actual Study Completion Date: Aug 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VAL-339851	Biological: VAL-339851; Escalating dose levels
Placebo Comparator: Placebo	Other: Placebo; Saline

Outcome Measures

Primary Outcome Measures

1. Frequency of solicited AEs (local and systemic reactogenicity events) [7 days following each dose administration]

2. Frequency of unsolicited adverse events [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 [One year after last dose administration]

Secondary Outcome Measures

1. Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample [One year after last dose administration]

2. Seroconversion rates in comparison to baseline samples [One year after last dose administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Research Associates	Miami	Florida	United States	33143

Sponsors and Collaborators

• ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ModernaTX, Inc.
• ClinicalTrials.gov Identifier: NCT03345043
• Other Study ID Numbers: VAL-339851-P101
• First Posted: Nov 17, 2017
• Last Update Posted: Jan 11, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Influenza, Human

Study Results

No Results Posted as of Jan 11, 2021