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

NCT03345043 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VAL-339851-P101
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

VAL-339851; H7N9 antigen mRNA; Influenza vaccine; Moderna

Outcome Measures

Primary Outcomes (3)

• Frequency of solicited AEs (local and systemic reactogenicity events)

  7 days following each dose administration

• Frequency of unsolicited adverse events

  21 days following each dose administration

• 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 Outcomes (2)

• Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample

  One year after last dose administration

• Seroconversion rates in comparison to baseline samples

  One year after last dose administration

Study Arms (2)

VAL-339851

EXPERIMENTAL

Biological: VAL-339851

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

VAL-339851 BIOLOGICAL

Escalating dose levels

VAL-339851

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 49 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 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Miami Research Associates

Miami, Florida, 33143, United States

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: May 11, 2016
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)