Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults

NCT ID: NCT03392389

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2019-07-29

Brief Summary

This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy adults.

Conditions

Human Metapneumovirus and Human Parainfluenza Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

mRNA-1653

Group Type: EXPERIMENTAL

mRNA-1653

Intervention Type: BIOLOGICAL

Escalating dose levels

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Saline

Interventions

mRNA-1653

Escalating dose levels

Intervention Type: BIOLOGICAL

Placebo

Saline

Intervention Type: OTHER

Eligibility Criteria

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
• In good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed prior to initial study vaccination
• 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 30 days prior to enrollment and through 3 months following last vaccination
• Willing to comply with the requirements of the protocol (eg, complete Diary Cards, return for follow-up visits, be available for safety phone calls)

Exclusion Criteria

• Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
• A history of malignancy in the last 10 years
• If female and of childbearing potential, is pregnant or lactating, has not adhered to an adequate contraception method from at least 30 days before study entry, or does not plan to do so for at least 3 months after the last vaccination
• Abnormal screening safety laboratory test results including liver enzyme tests
• Administration of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine or has plans for administration during the study period
• Prior administration of investigational agent using lipid nanoparticle formulations
• A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
• A positive test result for drugs of abuse
• Chronic administration of potentially hepatotoxic drugs or have other medical conditions that affect the liver (eg, alcohol abuse)
• A history of idiopathic urticaria
• Plans for administration or has been administered a vaccine within the period from 30 days before through 30 days after each study vaccination, with the exception of any licensed influenza vaccine administered ≥15 days before or after any study vaccination
• Any chronic administration of an immunosuppressant or other immune modifying drug
• Prior administration of immunoglobulins and/or any blood products within the 3 months before the first study vaccine or has plans for administration during the study period
• Any known or suspected immune-mediated disease or immunosuppressive condition as determined by medical history and/or physical examination
• A history of hypersensitivity or serious reactions to previous vaccinations
• Any bleeding disorder considered a contraindication to IM injection or blood draw
• Any acute illness or fever at screening
• 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 study drug or interpretation of study results
• Donation of blood or blood products > 450 mL within 30 days of dosing.
• Is an immediate family member or household member of study personnel

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Benchmark Research

Austin, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

mRNA-1653-P101

Identifier Type: -

Identifier Source: org_study_id