mRNA-1647 Dose A for Cytomegalovirus (CMV)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cytomegalovirus (CMV)
mRNA-1647 - Biological
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition,mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cytomegalovirus (CMV)

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: Up to Day 176 (7 days after the last study injection)

Day 176
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Day 197
Number of Unsolicited Adverse Events (AEs)
Month 6
Number of Medically Attended Adverse Events (MAAEs)
Day 527
GMFR of Binding Anti-gB and Anti-pentamer Specific IgG
Immunoglobulin G
Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs
Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs)
Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG
Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies
Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation

Trial Safety

Safety Progress

1 of 3

Other trials for Cytomegalovirus (CMV)

Trial Design

5 Treatment Groups

mRNA-1647 Dose A
1 of 5
mRNA-1647 Dose C
1 of 5
mRNA-1647 Dose B
1 of 5
Dose Expansion: mRNA-1647
1 of 5
Dose Expansion: Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

770 Total Participants · 5 Treatment Groups

Primary Treatment: mRNA-1647 Dose A · Has Placebo Group · Phase 1 & 2

mRNA-1647 Dose A
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
mRNA-1647 Dose C
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
mRNA-1647 Dose B
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
Dose Expansion: mRNA-1647
Biological
Experimental Group · 1 Intervention: mRNA-1647 · Intervention Types: Biological
Dose Expansion: 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

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 176 (7 days after the last study injection)

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
65 Previous Clinical Trials
50,288,427 Total Patients Enrolled
1 Trials studying Cytomegalovirus (CMV)
300 Patients Enrolled for Cytomegalovirus (CMV)

Eligibility Criteria

Age < 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 9 to 15 years of age or are 16 to 25 years of age at the time of consent.
You are in good general health, in the opinion of the Investigator, and is capable of complying with study procedures.
You have a body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) Child Growth Standards.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 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.