EBV Vaccine for EBV Infection

Overseen By Jessica R Durkee-Shock, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, Cytotoxic, Blood products, others

Disqualifiers: Pregnancy, Obesity, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and immune response of a new vaccine against the Epstein-Barr virus (EBV), which causes mono and is linked to some cancers. The vaccine may prevent long-term fatigue and severe complications in affected individuals. Healthy adults aged 18-29, with no major health issues and willing to follow study procedures for about 18 months, are ideal candidates. Participants will receive three doses of the EBV gp350-Ferritin Nanoparticle Vaccine, with follow-ups to monitor health and any side effects. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance 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, you cannot have taken certain medications like systemic immunosuppressive drugs or live vaccines shortly before the trial starts.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the EBV gp350-Ferritin Nanoparticle Vaccine underwent testing in early studies to assess its safety. In these studies, healthy adults received three doses of the vaccine, and researchers observed its tolerability. Participants were monitored for any side effects or health issues. So far, results have been promising, with no major safety concerns reported. This suggests the vaccine might be well-tolerated, but further studies are needed to confirm these findings. Early trials primarily focus on safety, so prospective participants should be aware that this vaccine is still under careful evaluation for any risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Epstein-Barr virus (EBV) infections, which primarily focus on managing symptoms or complications, the EBV gp350-Ferritin Nanoparticle Vaccine offers a proactive approach by aiming to prevent EBV infection altogether. This vaccine is unique because it uses a nanoparticle delivery system to present the gp350 protein from the virus, potentially enhancing the immune response and offering long-term protection. Researchers are excited about this treatment because it targets the virus directly, potentially reducing the risk of EBV-related diseases in the future.

What evidence suggests that this vaccine might be an effective treatment for EBV infection?

Research has shown that the EBV gp350-Ferritin Nanoparticle Vaccine, administered to participants in this trial, could help prevent Epstein-Barr virus (EBV) infections. Studies have found that this vaccine boosts the immune system, enabling the body to recognize and combat the virus. The vaccine employs tiny particles to enhance this immune response, increasing its effectiveness. Early results suggest it might reduce the risk of issues associated with EBV, such as persistent fatigue and certain cancers. Although more information is needed, the vaccine's design and initial findings are promising for future EBV prevention. ^{1 3 4 6 7}

Who Is on the Research Team?

Jessica R Durkee-Shock, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

Healthy adults aged 18-29 can join this trial to test a new EBV vaccine. They must be in good health, not planning to receive other live vaccines around the study period, and willing to use effective contraception. People with severe reactions to vaccines, certain chronic diseases like uncontrolled asthma or diabetes, or those on immunosuppressive drugs cannot participate.

Inclusion Criteria

My partner uses effective birth control or has had surgery to prevent pregnancy.

I use hormonal birth control and a barrier method during sex.

I am using or agree to use effective birth control during and 60 days after the vaccine study.

Exclusion Criteria

My asthma has been severe, needing emergency care or steroids in the last 2 years.

My cancer is active or likely to come back during the study.

I haven't taken strong immune system medications or cancer drugs in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Vaccination

Participants receive 3 doses of the EBV gp350-Ferritin nanoparticle vaccine at 0, 1, and 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and immune response, including local and systemic reactogenicity, adverse events, and antibody response

12 months

4 visits (in-person), 6 telephone calls

Long-term Follow-up (optional)

Participants have the option to be followed for an additional year to monitor long-term safety and immune response

12 months

1 visit (in-person or telephone)

What Are the Treatments Tested in This Trial?

Interventions

• EBV gp350-Ferritin Nanoparticle Vaccine

Trial Overview The trial is testing the safety and immune response of an Epstein-Barr Virus (EBV) gp350-Ferritin nanoparticle vaccine with Matrix-M1 adjuvant in healthy young adults. Participants will get three doses of the vaccine over several months and have follow-ups for about 18 months.

How Is the Trial Designed?

Group I: EBV gp_350 Ferritin Vaccination Experimental Treatment 2 Interventions

Adult participants with or without prior EBV infection will receive 3 doses of vaccine

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

In a study of asymptomatic infants in Kisumu, Kenya, researchers found that coinfection with both EBV-1 and EBV-2 was common, which affected the antibody response, particularly resulting in lower levels of anti-gp350 IgA antibodies.

The lower levels of anti-gp350 IgA in coinfected infants suggest that these antibodies are crucial for preventing secondary infections, highlighting the need for an EBV vaccine that addresses both strains to effectively protect populations at high risk for Burkitt lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the Epstein-Barr Virus gp350 IgA Antibody Response Are Associated With Increased Risk for Coinfection With a Second Strain of Epstein-Barr Virus. Smith, NA., Baresel, PC., Jackson, CL., et al.[2020]

Current research suggests that while a monomeric EBV gp350 vaccine reduced the incidence of infectious mononucleosis in a phase 2 trial, newer formulations like multimeric forms and nanoparticles may enhance its effectiveness.

Developing a comprehensive EBV vaccine that includes various viral proteins could potentially reduce the risk of infectious mononucleosis and associated complications, as well as EBV-related malignancies such as Hodgkin lymphoma and multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine Development for Epstein-Barr Virus. Cohen, JI.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04645147

Safety and Immunogenicity of an Epstein-Barr Virus (EBV) ... Phase 1 study to evaluate the safety and immunogenicity of a 3-dose vaccination regimen of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine. Based on data ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031204/

A Liposome-Based Nanoparticle Vaccine Induces Effective ... Conclusions: Altogether these data demonstrated that the liposome displaying promoted the immunogenicity of antigens, and the Lipo-gp350D123 ...

3. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1530364/full

A self-assembled nanoparticle vaccine elicits effective ... Conclusion: These data indicate that the L350–ferritin nanoparticle vaccine candidate has considerable potential application in preventing EBV ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06908096

NCT06908096 | Epstein-Barr Virus (EBV) gH/gL/gp42- ... This is a phase 1 study to evaluate the safety of a 3-dose vaccination regimen of an adjuvanted EBV gH/gL/gp42-ferritin nanoparticle vaccine with or without ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4757492/

Rational Design of an Epstein-Barr Virus Vaccine Targeting ... Structurally designed EBV vaccine candidates based on self-assembling nanoparticles elicit potent and durable virus-neutralizing antibodies that ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04645147/safety-and-immunogenicity-of-an-epstein-barr-virus-ebv-gp350-ferritin-nanoparticle-vaccine-in-healthy-adults-with-or-without-ebv-infection

Safety and Immunogenicity of an Epstein-Barr Virus (EBV) ... Phase 1 study to evaluate the safety and immunogenicity of a 3-dose vaccination regimen of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1074761325000354

Structural basis for complement receptor engagement and ... An EBV gp350-ferritin nanoparticle is one candidate vaccine with promising pre-clinical data in mice and NHPs, and has advanced to clinical ...