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

Moderna

Status and phase

Completed

Phase 1

Conditions

Cytomegalovirus Infection

Treatments

Biological: mRNA-1647

Biological: mRNA-1443

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03382405

mRNA-1647/mRNA-1443-P101

Details and patient eligibility

About

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

Enrollment

181 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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