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Cancer Vaccine

mRNA EBV Vaccine 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 85, and 197
Awards & highlights

Study Summary

This trial tests a new vaccine to find out if it is safe and how it affects people 18-55.

Who is the study for?
This trial is for healthy adults aged 18-55 who either have been exposed to EBV (Part A) or not (Part B). Participants must be in good health, able to follow the study plan, and if female and able to become pregnant, they must use effective birth control. People with recent fevers, unstable chronic illnesses, drug/alcohol abuse history, or those on certain immune-altering drugs can't join.Check my eligibility
What is being tested?
The study tests the safety of an Epstein-Barr Virus vaccine called mRNA-1195 in two forms (mRNA-1195.1 and mRNA-1195.2), comparing it against another candidate vaccine mRNA-1189 and a placebo. The goal is to see how participants' bodies react to these vaccines.See study design
What are the potential side effects?
Possible side effects may include typical reactions at the injection site like pain or swelling, feverish symptoms shortly after vaccination, fatigue, headache or muscle pains which are common responses indicating that the body is building protection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 85, and 197
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 85, and 197 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 Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AEs of Special Interest (AESIs)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Secondary outcome measures
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or 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

15Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part B: mRNA-1195.1 or mRNA-1195.2 Middle DoseExperimental Treatment2 Interventions
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.
Group II: Part B: mRNA-1195.1 or mRNA-1195.2 Low DoseExperimental Treatment2 Interventions
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.
Group III: Part B: mRNA-1195.1 or mRNA-1195.2 High DoseExperimental Treatment2 Interventions
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
Group IV: Part A: mRNA-1195.2 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
Group V: Part A: mRNA-1195.2 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
Group VI: Part A: mRNA-1195.2 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
Group VII: Part A: mRNA-1195.2 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
Group VIII: Part A: mRNA-1195.1 Dose Level 4Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
Group IX: Part A: mRNA-1195.1 Dose Level 3Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
Group X: Part A: mRNA-1195.1 Dose Level 2Experimental Treatment1 Intervention
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
Group XI: Part A: mRNA-1195.1 Dose Level 1Experimental Treatment1 Intervention
Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
Group XII: Part A: mRNA-1189Active Control1 Intervention
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Group XIII: Part B: mRNA-1189Active Control1 Intervention
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Group XIV: Part A: PlaceboPlacebo Group1 Intervention
Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.
Group XV: Part B: PlaceboPlacebo Group1 Intervention
Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Find a Location

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
61,377,771 Total Patients Enrolled

Media Library

mRNA-1195 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05831111 — Phase 1
EBV Infection Research Study Groups: Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose, Part A: mRNA-1189, Part A: Placebo, Part A: mRNA-1195.2 Dose Level 1, Part B: mRNA-1195.1 or mRNA-1195.2 High Dose, Part A: mRNA-1195.1 Dose Level 4, Part A: mRNA-1195.1 Dose Level 1, Part B: mRNA-1189, Part B: Placebo, Part A: mRNA-1195.2 Dose Level 2, Part A: mRNA-1195.2 Dose Level 4, Part A: mRNA-1195.1 Dose Level 3, Part A: mRNA-1195.2 Dose Level 3, Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose, Part A: mRNA-1195.1 Dose Level 2
EBV Infection Clinical Trial 2023: mRNA-1195 Highlights & Side Effects. Trial Name: NCT05831111 — Phase 1
mRNA-1195 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05831111 — Phase 1
EBV Infection Patient Testimony for trial: Trial Name: NCT05831111 — Phase 1

Frequently Asked Questions

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

How pervasive is this experiment in Canadian medical facilities?

"Noble Clinical Research in Tucson, Arizona, Marvel Clinical Research in Huntington Beach, California and Longmonth Medical Research Network in Longmont, Colorado are three of the 33 clinical trial sites offering this study."

Answered by AI

What types of participants are required for this research?

"Eligible candidates for this medical trial are those between 18 and 55 years of age with a confirmed case of ebv infection. Approximately 500 patients will be admitted into the study."

Answered by AI

What can be said about the security of Part A: mRNA-1195.1 Dose Level 1 for human use?

"Our internal assessment of the safety profile for Part A: mRNA-1195.1 Dose Level 1 yielded a rating of 1 due to this being an initial Phase I trial and only having minimal evidence in regards to both efficacy and security."

Answered by AI

Is eligibility limited to those under 65 years of age for this experiment?

"This medical trial has a fairly restrictive inclusion criteria, limited to those aged 18-55. There are alternative clinical studies available for children and seniors respectively; 18 trials specifically target the former while 27 of them focus on individuals over 65 years old."

Answered by AI

Are there still vacancies available to enroll in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is still seeking to enroll patients, with the first posting dating back to April 5th 2023 and a recent edit on April 14th 2023. 500 individuals are needed across 30 medical sites."

Answered by AI

What is the aggregate figure of subjects taking part in this experiment?

"Affirmative. According to the information published on clinicaltrials.gov, this research endeavour is presently seeking volunteers; it was first advertised on April 5th 2023 and updated most recently on April 14th 2023. The study requires 500 individuals from 30 different sites for enrolment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Suncoast Research Group, LLC
Las Vegas Clinical Trials, LLC
DM Clinical Research - Philadelphia

Why did patients apply to this trial?

I have ongoing issues with EBV,. Saw info online and was interested in being on the Epstein Barr vaccine trial.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults
2023. "A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05831111.
All > Ebv > Tucson
~225 spots leftby Feb 2026
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