Verified

mRNA-1189 for EBV Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alliance for Multispecialty Research LLC, East Wichita, Wichita, KSVerifiedEBV InfectionmRNA-1189 - Biological
Eligibility
18 - 30
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a vaccine for safety and how the body reacts to it.

Eligible Conditions
  • Epstein-Barr Virus (EBV) Infection

Treatment Effectiveness

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: Days 1, 85, and 197

Day 505
Vaccines
Day 1
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb
Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs
Up to Day 176
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Day 176
Number of Participants with Laboratory Abnormalities
Day 197
Number of Participants with Unsolicited Adverse Events (AEs)

Trial Safety

Trial Design

4 Treatment Groups

mRNA-1189 Dose Level 2
1 of 4
mRNA-1189 Dose Level 1
1 of 4
mRNA-1189 Dose Level 3
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

272 Total Participants · 4 Treatment Groups

Primary Treatment: mRNA-1189 · Has Placebo Group · Phase 1

mRNA-1189 Dose Level 2
Biological
Experimental Group · 1 Intervention: mRNA-1189 · Intervention Types: Biological
mRNA-1189 Dose Level 1
Biological
Experimental Group · 1 Intervention: mRNA-1189 · Intervention Types: Biological
mRNA-1189 Dose Level 3
Biological
Experimental Group · 1 Intervention: mRNA-1189 · Intervention Types: Biological
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 1, 85, and 197

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor
72 Previous Clinical Trials
50,290,748 Total Patients Enrolled

Eligibility Criteria

Age 18 - 30 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you are a woman, you cannot be pregnant or breastfeeding during the 18-month trial period.
You must be between 18 and 30 years old to participate.
You are healthy or have a medical condition that is being properly managed.
Can you commit to visiting the study site around 15 times over the next 18 months? You will be paid for your time and travel expenses related to the study.

Who else is applying?

What state do they live in?
Texas35.5%
California22.6%
Oklahoma6.5%
Other35.5%
How old are they?
18 - 65100.0%
What site did they apply to?
Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS9.1%
Fomat Medical Research13.6%
Smart Cures Clinical Research22.7%
Other54.5%
What portion of applicants met pre-screening criteria?
Did not meet criteria48.5%
Met criteria51.5%
Why did patients apply to this trial?
  • "I want money"
  • "An ad on Facebook"
  • "To see if I have EPV"
  • "I think vaccines are important"
  • "I had mononucleosis in the past."
How many prior treatments have patients received?
092.9%
27.1%
What questions have other patients asked about this trial?
  • "How much is compensation?"
  • "How much do you pay for it?"

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call50.0%
Email50.0%
Most responsive sites:
  1. Lynn Health Science Institute: < 48 hours
  2. Fomat Medical Research: < 48 hours

Frequently Asked Questions

Are seniors eligible to join this clinical experimentation?

"The inclusionary parameters for this medical study specify that applicants should be between the ages 18 to 30. There are 19 trials available for minors and 29 research opportunities specifically catered towards seniors." - Anonymous Online Contributor

Unverified Answer

How many venues are hosting this clinical exploration?

"Currently, recruitment for this trial is taking place at 34 sites throughout the United States. There are locations in Colton, Houston and Minneapolis as well as various other cities. To reduce travel demands associated with enrolment it may be beneficial to select a clinic near your area of residence." - Anonymous Online Contributor

Unverified Answer

Who is eligible to partake in this scientific investigation?

"This clinical trial seeks to recruit 272 individuals aged 18-30 that have Epstein Barr Virus. To qualify, participants must display good general health and a BMI of 18-35 kg/m^2 on the Day 0 screening visit." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned the use of mRNA-1189?

"The safety profile of mRNA-1189 was assigned a score of 1 due to the few preclinical and clinical studies available for this experimental medicinal product." - Anonymous Online Contributor

Unverified Answer

Is there still capacity for more participants in this research?

"According to clinicaltrials.gov, this trial is currently recruiting volunteers. Initially posted on December 28th 2021, the study was most recently updated on November 21st 2022." - Anonymous Online Contributor

Unverified Answer

Are there any limits to the amount of participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial is actively enrolling patients, with the original post made on December 28th 2021 and most recently modified on November 21st 2022. In total, 272 participants need to be recruited from 34 different locations for the study's completion." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.