Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults

Moderna

Status and phase: Completed; Phase 2

Conditions: Cytomegalovirus Infection

Treatments: Other: Placebo; Biological: mRNA-1647

Study type: Interventional

Funder types: Industry

Identifiers

NCT04232280

mRNA-1647-P202

Details and patient eligibility

About

This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.

Full description

mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity of 3 dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A planned interim analysis of safety and immunogenicity through Month 3 (1 month after the second dose) of Part 1 of the study informed the selection of the middle dose level for further development. Part 2 of the study is designed to further evaluate the safety and immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of CMV-seronegative and CMV-seropositive female population, which includes the target population for the pivotal Phase 3 efficacy trial.

Enrollment: 315 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2)
• Understands and agrees to comply with the trial procedures and provides written informed consent
• According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures
• Body mass index (BMI) 18-35 kilograms/meter (kg/m^2)
• Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding.
• Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after the last vaccination.

Exclusion criteria

• Acutely ill or febrile on the day of the first vaccination
• Prior receipt of any CMV vaccine
• Abnormal screening safety laboratory test results
• Diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures
• Has received or plans to receive a vaccine ≤28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered >14 days before or after any study vaccination. COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations.
• Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
• Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
• Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only)
• Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit
• Participated in an interventional clinical trial within 28 days prior to the day of enrollment
• Is an immediate family member or household member of trial personnel

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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315 participants in 4 patient groups, including a placebo group

mRNA-1647 Dose Level A

Experimental group

Description:

Participants will receive mRNA-1647 vaccine at Dose Level A by intramuscular (IM) injection on Day 1, Day 56, and Day 168.

Treatment:

Biological: mRNA-1647

mRNA-1647 Dose Level B

Experimental group

Description:

Participants will receive mRNA-1647 vaccine at Dose Level B by IM injection on Day 1, Day 56, and Day 168.

Treatment:

Biological: mRNA-1647

mRNA-1647 Dose Level C

Experimental group

Description:

Participants will receive mRNA-1647 vaccine at Dose Level C by IM injection on Day 1, Day 56, and Day 168.

Treatment:

Biological: mRNA-1647

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.

Treatment:

Other: Placebo