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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03392389
Collaborator
(none)
124
3
2
19.8
41.3
2.1

Study Details

Study Description

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
  • Biological: mRNA-1653
  • Other: Placebo
Phase 1

Study Design

Study Type:
Interventional
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 :
Dec 4, 2017
Actual Primary Completion Date :
Jul 29, 2019
Actual Study Completion Date :
Jul 29, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: mRNA-1653

Biological: mRNA-1653
Escalating dose levels

Placebo Comparator: Placebo

Other: Placebo
Saline

Outcome Measures

Primary Outcome Measures

  1. Frequency of solicited AEs (local and systemic reactogenicity events) [7 days following each dose administration]

  2. Frequency of unsolicited adverse events [28 days following each dose administration]

  3. Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs [one year following the last dose administration]

  4. Frequency of clinical laboratory adverse events [1 month following the last dose administration]

  5. Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies [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 [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 [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 [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 [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 [6 months and 1 year following the last dose administration]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meridian Clinical Research, LLC Omaha Nebraska United States 68134
2 Benchmark Research Austin Texas United States 78705
3 Benchmark Research Fort Worth Texas United States 76135

Sponsors and Collaborators

  • ModernaTX, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ModernaTX, Inc.
ClinicalTrials.gov Identifier:
NCT03392389
Other Study ID Numbers:
  • mRNA-1653-P101
First Posted:
Jan 8, 2018
Last Update Posted:
Feb 6, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ModernaTX, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2020