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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392389
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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.

Condition or disease Intervention/treatment Phase
Human Metapneumovirus and Human Parainfluenza Infection Biological: mRNA-1653 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus and Human Parainfluenza Virus Type 3 Vaccine, When Administered to Healthy Adults
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : July 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mRNA-1653 Biological: mRNA-1653
Escalating dose levels

Placebo Comparator: Placebo Other: Placebo
Saline




Primary Outcome Measures :
  1. Frequency of solicited AEs (local and systemic reactogenicity events) [ Time Frame: 7 days following each dose administration ]
  2. Frequency of unsolicited adverse events [ Time Frame: 28 days following each dose administration ]
  3. Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs [ Time Frame: one year following the last dose administration ]
  4. Frequency of clinical laboratory adverse events [ Time Frame: 1 month following the last dose administration ]
  5. Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies [ Time Frame: 1 month following the last dose administration ]
  6. Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination [ Time Frame: 1 month following the last dose administration ]
  7. Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline [ Time Frame: 1 month following the last dose administration ]

Secondary Outcome Measures :
  1. Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies [ Time Frame: 6 months and 1 year following the last dose administration ]
  2. Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination [ Time Frame: 6 months and 1 year following the last dose administration ]
  3. Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline [ Time Frame: 6 months and 1 year following the last dose administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392389


Locations
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United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research
Fort Worth, Texas, United States, 76135
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT03392389    
Other Study ID Numbers: mRNA-1653-P101
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1653
human metapneumovirus
human parainfluenza vaccine
Additional relevant MeSH terms:
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Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases