Epstein-Barr VirusPhase 1NCT07478952
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age
A Phase 1 study testing mRNA-1189 in people with Epstein-Barr Virus, run by ModernaTX, Inc. at 2 sites in Australia.
Trial summary
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Epstein-Barr Virus
- What is being tested?
- mRNA-1189
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustralia
- Study dates
- 17 Mar 2026to 15 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by medical evaluation including medical history and physical examination.
- Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.
Who cannot join
- Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
- Received or plans to receive any nonstudy vaccine from 28 days prior to first dose/Day 1 up to 28 days after the second dose/Day 57.
- History of myocarditis, pericarditis, or myopericarditis prior to Day 1.
- Has previously received an investigational EBV vaccine.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Nucleus Network
Melbourne, Victoria, VIC 3004
- Not yet recruiting
Doherty Clinical Trials
Melbourne, Victoria, VIC 3149
About this study
Official title: A Phase 1, Randomized, Open-label Study to Evaluate Safety, Reactogenicity, and Immunogenicity of an Epstein-Barr Virus Candidate Vaccine, mRNA-1189, Following Intradermal and Intramuscular Delivery in Healthy Adults 18 to 30 Years of Age
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
- Conditions
- Epstein-Barr Virus
- Being tested
- mRNA-1189
- Keywords
- Epstein-Barr Virus (EBV)
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1189Biological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1189 Dose Level 1 (ID) | Experimental | Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. Receives: Biological: mRNA-1189 |
| mRNA-1189 Dose Level 2 (ID) | Experimental | Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. Receives: Biological: mRNA-1189 |
| mRNA-1189 Dose Level 1 (IM) | Experimental | Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. Receives: Biological: mRNA-1189 |
| mRNA-1189 Dose Level 2 (IM) | Experimental | Participants will receive 2 IM injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. Receives: Biological: mRNA-1189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to Day 64 (7-day follow-up after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to Day 85 (28-day follow-up after vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Measured: Day 1 up to Day 225
Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
Measured: Day 1 to end of study (EOS) (Day 225)
Secondary outcomes (3)
Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)
Measured: Days 1 and 85
Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb
Measured: Day 85
Number of Participants With Seroconversion of Antigen-Specific bAbs
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start17 Mar 2026
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr VirusStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478952
- Sponsor's protocol ID
- mRNA-NEXT-001
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label Study to Evaluate Safety, Reactogenicity, and Immunogenicity of an Epstein-Barr Virus Candidate Vaccine, mRNA-1189, Following Intradermal and Intramuscular Delivery in Healthy Adults 18 to 30 Years of Age
- ClinicalTrials.gov ID
- NCT07478952
- Acronym / sponsor ID
- mRNA-NEXT-001
- Conditions
- Epstein-Barr Virus
- Keywords
- Epstein-Barr Virus (EBV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mRNA-1189 Dose Level 1 (ID) | Experimental | Biological: mRNA-1189Participants will receive 2 intradermal (ID) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. |
| mRNA-1189 Dose Level 2 (ID) | Experimental | Biological: mRNA-1189Participants will receive 2 ID injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. |
| mRNA-1189 Dose Level 1 (IM) | Experimental | Biological: mRNA-1189Participants will receive 2 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1 and 57. |
| mRNA-1189 Dose Level 2 (IM) | Experimental | Biological: mRNA-1189Participants will receive 2 IM injections of mRNA-1189 at Dose Level 2 on Days 1 and 57. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy as determined by medical evaluation including medical history and physical examination.
- Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding.
Key exclusion criteria (8 listed)
- Have undergone surgical procedures within 7 days prior to Day 1 or Day 57 or are scheduled to undergo a surgical procedure within 28 days after study intervention administration.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- Received corticosteroids at ≥10 milligrams per day (mg/day) of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses, within 180 days prior to Day 1 or plans to do so during the study.
- Received or plans to receive any nonstudy vaccine from 28 days prior to first dose/Day 1 up to 28 days after the second dose/Day 57.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1189Sterile liquid for injection | Biological | mRNA-1189 Dose Level 1 (ID), mRNA-1189 Dose Level 1 (IM), mRNA-1189 Dose Level 2 (ID), mRNA-1189 Dose Level 2 (IM) |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 64 (7-day follow-up after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 85 (28-day follow-up after vaccination)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 up to Day 225
Number of Participants With Serious Adverse Events (SAEs), Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)
Time frame: Day 1 to end of study (EOS) (Day 225)
3 secondary outcomes
Geometric Mean Titer of Antigen-Specific Binding Antibody (bAb)
Time frame: Days 1 and 85
Geometric Mean Fold Rise (GMFR) of Antigen-Specific bAb
Time frame: Day 85
Number of Participants With Seroconversion of Antigen-Specific bAbs
Time frame: Day 85
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1189 in people with Epstein-Barr Virus, run by ModernaTX, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCare Team (1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Up to Day 64 (7-day follow-up after vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.