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Trial record 14 of 50 for:    Recruiting, Not yet recruiting, Available Studies | "Cytomegalovirus Infections"

Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03382405
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Moderna Therapeutics

Brief Summary:
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Biological: mRNA-1647 Biological: mRNA-1443 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel 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 Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mRNA-1647 Biological: mRNA-1647
Escalating dose levels

Experimental: mRNA-1443 Biological: mRNA-1443
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: 29 days following each dose administration ]
  3. Frequency of medically-attended AEs, adverse events of special interest (AESI), and serious adverse events (SAE) [ 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 ]

Secondary Outcome Measures :
  1. Titers of anti-CMV neutralizing antibodies against epithelial cell infection measured by neutralization assay in comparison with baseline sample [ Time Frame: 6 months following the last dose administration ]
  2. Titers of anti-CMV neutralizing antibodies against fibroblast cell infection measured by neutralization assay in comparison with baseline sample [ Time Frame: 6 months following the last dose administration ]
  3. Titers of vaccine antigen-specific IgG antibodies as measured by ELISA assay in comparison with baseline sample [ Time Frame: 6 months following the last dose administration ]
  4. Frequencies of vaccine antigen-specific CD4 and CD8 T cells secreting interferon gamma as determined by ELISPOT [ Time Frame: 6 months following the last dose administration ]


Information from the National Library of Medicine

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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
  • Dose-escalation phase only, is seropositive for CMV at the Screening visit
  • 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): NCT03382405


Contacts
Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com

Locations
United States, Illinois
Optimal Research Recruiting
Peoria, Illinois, United States, 61614
Contact    309-672-1910      
United States, Kansas
Johnson County Clinical Trials Recruiting
Lenexa, Kansas, United States, 66219
Contact    913-825-4400      
United States, Maryland
Optimal Research ), tel: Not yet recruiting
Rockville, Maryland, United States, 20850
Contact    301-309-8610      
Sponsors and Collaborators
Moderna Therapeutics

Responsible Party: Moderna Therapeutics
ClinicalTrials.gov Identifier: NCT03382405     History of Changes
Other Study ID Numbers: mRNA-1647/mRNA-1443-P101
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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 Moderna Therapeutics:
cytomegalovirus vaccine
mRNA-1647
mRNA-1443

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs