mRNA EBV Vaccine for EBV Infection

Not currently recruiting at 50 trial locations

Overseen By Moderna WeCare Team

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Acute illness, Chronic illness, Myocarditis, others

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and body response to a new mRNA vaccine designed to protect against the Epstein-Barr Virus (EBV), which can cause infectious mononucleosis and other illnesses. Different groups in the trial will receive either the mRNA vaccine (mRNA-1195) at various doses or a placebo (a harmless, non-active substance). The trial seeks healthy participants who have been diagnosed with EBV or have never been infected. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or immune-modifying drugs, you may not be eligible. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

An earlier study tested a vaccine similar to mRNA-1195 on 148 healthy adults. The vaccine proved safe, with most participants tolerating it well. Reports of serious side effects were rare. Most reactions were mild, such as soreness at the injection site or a slight fever, which are common with many vaccines. This suggests that mRNA-1195 might also be well-tolerated. However, as this is an early-stage trial, further research is necessary to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about mRNA-1195 for Epstein-Barr Virus (EBV) infection because it uses a groundbreaking mRNA technology to stimulate the immune system. Unlike traditional vaccines, which often use weakened or inactive viruses, mRNA vaccines offer a safer and more precise approach by teaching cells to produce viral proteins, prompting an immune response without exposure to the virus itself. This innovative method could lead to a stronger and more targeted defense against EBV, a virus linked to several diseases. Plus, mRNA vaccines can be developed and updated more rapidly than conventional vaccines, making them a promising tool for tackling viral infections.

What evidence suggests that this trial's treatments could be effective for EBV infection?

Research has shown that the mRNA-1195 vaccine, which participants in this trial may receive, may help prevent Epstein-Barr virus (EBV) infections. In earlier studies, 70% of participants developed protective antibodies after receiving the vaccine. It also reduced the risk of infectious mononucleosis, an illness caused by EBV, by 78%. These results suggest that mRNA-1195 could effectively protect against illnesses related to EBV. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

For Part A: Positive EBV serostatus at Screening

For Part B: Negative EBV serostatus at Screening

Is in good general health and can comply with study procedures

Exclusion Criteria

Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1

My chronic illness is stable and hasn't required new treatments in the last 2 months.

Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive 3 IM injections of either mRNA-1189, mRNA-1195.1, or mRNA-1195.2 at various dose levels on Days 1, 57, and 169

24 weeks

3 visits (in-person)

Treatment Part B

Participants receive 3 IM injections of mRNA-1195 at low, middle, or high dose levels on Days 1, 57, and 169

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1195

Trial Overview 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.

How Is the Trial Designed?

Group I: Part B: mRNA-1195 Middle Dose Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of mRNA-1195 (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 Low Dose Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of mRNA-1195 (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 High Dose Experimental Treatment 1 Intervention

Participants will receive 3 IM injections of mRNA-1195 (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 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 4 Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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-1189 Active Control 1 Intervention

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Group XIII: Part A: Placebo Placebo Group 1 Intervention

Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.

Group XIV: Part B: Placebo Placebo Group 1 Intervention

Participants will receive 3 IM injections of study drug-matching placebo on Days 1, 57, and 169.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

In a study of 510 university students, penetrative sexual intercourse was identified as a significant risk factor for acquiring Epstein-Barr virus (EBV), with 46% of initially EBV-seronegative students seroconverting over three years, and 25% of those developing infectious mononucleosis (IM).

EBV type 1 was found to be more likely associated with IM compared to silent seroconversion, suggesting that a vaccine targeting EBV could potentially prevent IM by reducing viral load rather than requiring complete immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cohort study among university students: identification of risk factors for Epstein-Barr virus seroconversion and infectious mononucleosis. Crawford, DH., Macsween, KF., Higgins, CD., et al.[2022]

A study involving 1217 females with suspected adverse events after HPV vaccination found that EBV infection around the time of vaccination is not a significant risk factor for these events, as only a small number had recent EBV infections.

The higher rates of EBV testing among those reporting adverse events suggest that the symptoms attributed to the vaccine may actually be due to other factors, rather than a direct link to the HPV vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are unexplained adverse health events following HPV vaccination associated with infectious mononucleosis? - A Danish nationwide matched case-control study. Krogsgaard, LW., Helmuth, IG., Bech, BH., et al.[2021]

The recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine was tested in 148 healthy adult volunteers and demonstrated a good safety profile, with most side effects being mild and acceptable, although one serious adverse event was reported.

The vaccine formulations were effective in generating immune responses, specifically inducing gp350-specific antibodies, including neutralizing antibodies, indicating potential efficacy in protecting against EBV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults. Moutschen, M., Léonard, P., Sokal, EM., et al.[2007]

Citations

1. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1195-P201

A Clinical Trial of an Epstein-Barr Virus (EBV) Vaccine for ... The Horizon Trial will evaluate the safety and effectiveness of an investigational vaccine aimed at preventing Epstein-Barr virus (EBV) in adults 18–55 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05831111

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine ... The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants. Detailed Description. There will be 2 sequential ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10634406/

Epstein-Barr virus and autoimmunity: effective preventive ... Although it induced neutralizing antibodies in 70% of participants and reduced the incidence of infectious mononucleosis by 78%, it failed to effectively ...

4. connect.trialscope.com connect.trialscope.com/studies/311311d9-49e2-4cb3-8662-d0ed72a01e29

A clinical trial of an investigational Epstein-Barr virus (EBV ... The purpose of the Horizon Trial is to evaluate the safety and effectiveness of an investigational vaccine, called mRNA-1195, aimed at preventing EBV in adults ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12300508/

Recent Progress in the Vaccine Development Against ... More importantly, the vaccine showed significant efficacy against infectious mononucleosis caused by the EBV infection, with a protective efficacy of 78% (95% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05831111

NCT05831111 | A Study of an Epstein-Barr Virus (EBV) ... The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.

7. withpower.com withpower.com/trial/phase-1-epstein-barr-virus-infections-3-2023-6556b

mRNA EBV Vaccine for EBV Infection · Info for Participants The recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine was tested in 148 healthy adult volunteers and demonstrated a good safety profile, with most side ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2950329925000554

Epstein-Barr virus mRNA vaccine synergizes with NK cells ... Combined administration of mRNA vaccine and NK cells synergistically improved therapeutic efficacy by durably suppressing or eradicating NPC tumors in ...