Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects

Influenza Clinical Trial

Official title:

A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of H10N8 Antigen mRNA in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076385
• Other study ID #: VAL-506440-P101
• Secondary ID: 2015-003452-48
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: October 2018

Study information

• Verified date: April 2022
• 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-506440 in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion

• Agrees to comply with the study procedures and provides written informed consent

• 18 to 64 years of age

• Body mass index between 18 and 30 kg/m2

• Negative urine pregnancy test at the Screening visit and the day of each vaccination.

• Female subjects must either be of non-childbearing potential or use highly effective methods of contraception from at least 2 months before the Screening Visit through 3 weeks post last vaccination

• In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination

Exclusion

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care

• Administration of an investigational product within 45 days

• Women who are pregnant or breastfeeding, or plan to become pregnant during the study

• Prior administration of investigational agent using formulations similar to VAL-506440

• History of a serious reaction to prior influenza vaccinations

• History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine

• Administration of any live attenuated vaccines within 4 weeks before enrollment, inactive vaccines within 2 weeks before enrollment, or plans to any vaccine within the vaccination period

• 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 bleeding risk or thromboembolic event or any related medical history

• Regular alcohol consumption > 3 units/day, or current user of any illicit drugs, or has a history of drug/alcohol abuse with 1 year of screening or has a positive urine drug/alcohol test at screening

• Persons employed in a capacity that involves handling poultry or wild birds

• Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies within 4 weeks before administration of the first vaccination, throughout the study

• Had major surgery or donation of blood or blood products within 4 weeks of dosing

• Current smoking of more than 10 cigarettes (or equivalent amount of tobacco) per day, and within 3 months prior to Screening

• Subject is an employee of the Sponsor or CRO involved in the study.

• Vulnerable subjects (e.g., a subject kept in detention).

• 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

• History of autoimmune disease

• Inadequate Liver Function as defined by AST, ALT, GGT, alkaline phosphatase and bilirubin > 1.5xULN

• Known allergy or history of anaphylaxis or other serious adverse reactions to any of the constituents of the study vaccine

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• VAL-506440
Escalating dose levels

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug		Through 13 months of study participation
Secondary	Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples		Through 13 months of study participation
Secondary	Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples		Through 13 months of study participation