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Cancer Vaccine
mRNA-1189 for EBV Infection
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
Do you consider the participant to be in stable health, including having an underlying condition that’s well-controlled?
Is the participant not pregnant or breastfeeding, or planning to be pregnant or breastfeeding during their trial participation?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 85, and 197
Awards & highlights
Study Summary
This trial is testing a vaccine for safety and how the body reacts to it.
Eligible Conditions
- Epstein-Barr Virus (EBV) Infection
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are in stable health, including having an underlying condition that’s well-controlled.
Select...
If you are a woman, you cannot be pregnant or breastfeeding during their trial participation.
Select...
You must be between 12 and 17 years old to participate.
Select...
Can you commit to visiting the study site around 15 in-person clinic visits and 10 phone calls over 19 months?
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 85, and 197
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 85, and 197
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vaccines
Number of Participants with Laboratory Abnormalities
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
+1 moreSecondary outcome measures
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
Trial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Group II: Part B: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Group III: Part B: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Group IV: Part B: mRNA-1189 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Group V: Part A: mRNA-1189 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Group VI: Part A: mRNA-1189 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Group VII: Part A: mRNA-1189 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Group VIII: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Group IX: Part B: PlaceboPlacebo Group1 Intervention
Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
107 Previous Clinical Trials
61,377,703 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be between 12 and 17 years old to participate.If you are a woman, you cannot be pregnant or breastfeeding during their trial participation.You are in stable health, including having an underlying condition that’s well-controlled.Can you commit to visiting the study site around 15 in-person clinic visits and 10 phone calls over 19 months?
Research Study Groups:
This trial has the following groups:- Group 1: Part A: mRNA-1189 Dose Level 2
- Group 2: Part A: mRNA-1189 Dose Level 3
- Group 3: Part A: mRNA-1189 Dose Level 4
- Group 4: Part A: Placebo
- Group 5: Part B: mRNA-1189 Dose Level 1
- Group 6: Part B: mRNA-1189 Dose Level 2
- Group 7: Part B: mRNA-1189 Dose Level 3
- Group 8: Part B: mRNA-1189 Dose Level 4
- Group 9: Part B: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
EBV Infection Patient Testimony for trial: Trial Name: NCT05164094 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
California
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS
Fomat Medical Research
Smart Cures Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
What questions have other patients asked about this trial?
How much is compensation? How much do you pay for it?
PatientReceived no prior treatments
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.
PatientReceived no prior treatments
I had mononucleosis in the past.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Lynn Health Science Institute: < 48 hours
- Fomat Medical Research: < 48 hours
Typically responds via
Email
Phone Call
Average response time
- < 2 Days
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