mRNA-1647 for Cytomegalovirus Infections

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cytomegalovirus Infections+2 More
mRNA-1647 - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of a new CMV vaccine in healthy adults, aged 18-40. It will test for safety and how well the vaccine works.

Eligible Conditions
  • Cytomegalovirus Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504

Day 504
Change from Baseline in Associated GMR of Anti-gB Specific IgG and Anti-Pentamer Specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Change from Baseline in GMR of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Change from Baseline in GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Change from Baseline in GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Change from Baseline in GMT of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Change from Baseline in GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Day 504
Change from Baseline in Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Day 504
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection
Day 504
Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Day 175
Frequency of Solicited Local and Systemic Adverse Reactions (ARs)
Day 196
Frequency of Unsolicited Adverse Events (AEs)
Month 6
Frequency of Medically-Attended Adverse Events (MAAEs)
Year 1
Frequency of Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

mRNA-1647 High Dose
1 of 4
mRNA-1647 Medium Dose
1 of 4
mRNA-1647 Low Dose
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

315 Total Participants · 4 Treatment Groups

Primary Treatment: mRNA-1647 · Has Placebo Group · Phase 2

mRNA-1647 High Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
mRNA-1647 Medium Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
mRNA-1647 Low Dose
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1647
2017
Completed Phase 1
~190

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 29, day 56, day 84, day 168, day 196, day 336, and day 504

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
65 Previous Clinical Trials
50,288,882 Total Patients Enrolled
4 Trials studying Cytomegalovirus Infections
7,400 Patients Enrolled for Cytomegalovirus Infections

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Part 1: We are looking for a male or female 18-40 years of age
You understand and agree to comply with the trial procedures and provide written informed consent.
According to the Investigator, the subject is in good general health and is capable of complying with trial procedures.
A person's body mass index (BMI) is between 18 and 35 kilograms/meter (kg/m^2) if they are considered healthy.
Women who want to participate in the study must have their fertility evaluated to make sure they are not pregnant, and if they are not pregnant, they must use contraception for the duration of the study
Men who receive the HPV vaccine must agree to use contraception from the time of the first dose until 3 months after the last dose.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.