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Cancer Vaccine

mRNA-1647 for Cytomegalovirus

Phase 1

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 29, 85, 169, 197, and 347

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new vaccine for cytomegalovirus in healthy Japanese adults.

Eligible Conditions

Cytomegalovirus (CMV)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 29, 85, 169, 197, and 347

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 29, 85, 169, 197, and 347

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 29, 85, 169, 197, and 347 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With AEs of Special Interest (AESIs)

Number of Participants With Medically-Attended AEs (MAAEs)

Number of Participants With Serious AEs (SAEs)

+2 more

Secondary outcome measures

GMFR of Anti-gB and Anti-Pentamer Specific IgG

GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1647Experimental Treatment1 Intervention

CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule.

Group II: PlaceboPlacebo Group1 Intervention

CMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1647

2021

Completed Phase 2

~510

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

106 Previous Clinical Trials

61,376,977 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults of any age capable of participating in this experiment?

"Prospective participants must meet the specified age range of 18 to 40 years old as noted in the study's eligibility criteria."

Answered by AI

Is participation in this trial still feasible for prospective volunteers?

"According to the information available on clinicaltrials.gov, recruitment for this research study is ongoing and was first published on November 8th 2021 with last update happening July 10th 2022."

Answered by AI

What is the sample size of this research endeavor?

"Yes, according to clinicaltrials.gov, this medical study is still open for enrollment and has been accepting patients since November 8th 2021. As of July 10th 2022, the trial requires 28 participants from three different sites."

Answered by AI

Has the regulatory agency sanction given its approval to mRNA-1647?

"Taking into account the limited evidence surrounding mRNA-1647's safety and efficacy, this compound was given a score of 1."

Answered by AI

What are the eligibility criteria for participation in this research?

"This clinical trial will enrol 28 Japanese adults, aged 18-40, who are in good health and have a BMI between 18 to 35kg/m^2. Additionally, participants must meet the following criteria: CMV IgG negative/IgM negative for those seronegative or CMV IgG positive/IgM negative or IgG positive/IgM positive for those seropositive. Furthermore, they need to be born in Japan with both parents and 4 grandparents having been born there too without living outside of Japan longer than 10 years combined."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647

2021. "A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05105048.