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

• ClinicalTrials.gov Identifier: NCT03382405
• Recruitment Status: Completed
• First Posted: December 22, 2017
• Last Update Posted: January 15, 2021
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 181 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
• Actual Primary Completion Date: October 28, 2020
• Actual Study Completion Date: October 28, 2020

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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
• Male subjects must agree to practice adequate contraception for 30 days prior to the first vaccination and through 3 months following the 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
• A history of seizure disorder for which anticonvulsants are currently prescribed

Contacts and Locations

Locations

United States, Florida

Research Centers of America

Hollywood, Florida, United States, 33024

United States, Idaho

Advanced Clinical Research

Meridian, Idaho, United States, 83642

United States, Illinois

Optimal Research

Peoria, Illinois, United States, 61614

United States, Kansas

Johnson County Clinical Trials

Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

ModernaTX, Inc.

More Information

• Responsible Party: ModernaTX, Inc.
• ClinicalTrials.gov Identifier: NCT03382405
• Other Study ID Numbers: mRNA-1647/mRNA-1443-P101
• First Posted: December 22, 2017
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

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 ModernaTX, Inc.:

cytomegalovirus vaccine; mRNA-1647; mRNA-1443; Moderna

Additional relevant MeSH terms:

Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections