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

NCT03076385 | Completed Phase 1 DMC

• 2 other identifiers: VAL-506440-P1012015-003452-48
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.

Conditions

Influenza

Keywords

VAL-506440; H10N8 antigen mRNA; Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples

  Through 13 months of study participation

• Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples

  Through 13 months of study participation

Study Arms (2)

VAL-506440

EXPERIMENTAL

Biological: VAL-506440

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

VAL-506440 BIOLOGICAL

Escalating dose levels

VAL-506440

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Unknown Facility

Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 31079849 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 10, 2017
• Study Start: December 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)