750 Participants Needed

EBV Vaccine for EBV Infection

JR
Overseen ByJessica R Durkee-Shock, M.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 immunosuppressive or cytotoxic medications within 30 days before the first vaccine dose, and you should not receive investigational products while on the study.

What data supports the effectiveness of the EBV gH/gL/gp42-ferritin nanoparticle vaccine and EBV gp350-ferritin vaccine treatment?

Research shows that a vaccine using similar components, like gp350 and gH/gL/gp42, can produce strong antibodies that block Epstein-Barr virus (EBV) infection in animal models. This suggests that the vaccine could potentially prevent EBV infections and related diseases in humans.12345

How is the EBV nanoparticle vaccine treatment different from other treatments for EBV infection?

The EBV nanoparticle vaccine is unique because it combines multiple viral proteins (gp350 and gH/gL/gp42) into a self-assembling nanoparticle, which helps the body produce strong antibodies to block the virus from entering cells. Unlike previous vaccines that focused only on gp350, this approach targets multiple proteins to enhance protection against EBV infection and related cancers.12456

What is the purpose of this trial?

Background:Epstein-Barr virus (EBV) is the primary cause of infectious mononucleosis, commonly known as mono. EBV infects more than 90% of the world s population. Mono can be serious, and it can lead to severe illnesses like cancer and autoimmune diseases. Researchers want to test vaccines that may help prevent EBV and associated diseases.Objective:To test two EBV vaccines: EBV gH/gL/gp42-ferritin and EBV gp350-ferritin.Eligibility:Healthy EBV-negative or EBV-positive people aged 18 to 29.Design:Participants will be screened. They will have a physical examination. They will give blood and saliva samples.They will receive 3 doses of the study vaccine as an injection in the shoulder muscle. They will get either one vaccine or a combination of both vaccines.Participants will get their first dose of the vaccine at visit 1, the second dose about 30 days later, and the final dose about 90 days after that.Participants will be given a memory aid so they can record any symptoms and side effects between visits. This can be done either on paper or online through a link that is emailed to them.There are 6 required in-person visits. There are also 2 optional visits. In between the in-person visits are 7 telehealth visits or phone calls. Each visit may take up to 4 hours.The study will last for about 17 months. Participants will have the option of staying in the study for an additional year.

Research Team

JR

Jessica R Durkee-Shock, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

Healthy adults, both with and without prior Epstein-Barr Virus (EBV) infection, are eligible for this trial. The study is designed to assess the safety of a new EBV vaccine given in three doses over four months.

Inclusion Criteria

Participants of reproductive potential who are sexually active with a partner who can impregnate them must use highly effective continuous contraception for at least 30 days prior to Day 0 and agree to continue use until 60 days after the last dose of vaccine
Able to provide informed consent
Laboratory criteria within 30 days or less prior to enrollment: Hemoglobin, white blood cell count, total lymphocyte count, platelet count, alanine aminotransferase, and serum IgG within specified ranges
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Exclusion Criteria

Pregnant, breastfeeding, or planning to become pregnant while participating through 60 days after the last dose of vaccine
Received blood products, investigational research agents, allergy treatment with antigen injections, or been a prior participant in an EBV vaccine clinical trial within specified time frames
Any medical, psychiatric, or social condition that, in the judgement of the investigator, is a contraindication to protocol participation or impairs the participant's ability to give informed consent
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Dose Escalation

Initial phase where 9 EBV-seropositive individuals receive varying doses of the vaccine to assess safety

1 month
3 visits (in-person)

Randomization

Participants receive 3 doses of the vaccine at 0, 1, and 4 months

4 months
6 visits (in-person), 7 telehealth visits or phone calls

Follow-up

Participants are monitored for safety and effectiveness after the last dose of the vaccine

12 months
2 optional visits (in-person)

Open-label Extension (optional)

Participants may opt into continuation of monitoring for an additional year

12 months

Treatment Details

Interventions

  • EBV gH/gL/gp42-ferritin nanoparticle vaccine
  • EBV gp350-ferritin vaccine
Trial Overview The trial tests two EBV vaccines combined with an adjuvant: one includes gH/gL/gp42-ferritin nanoparticle alone, while the other adds gp350-ferritin. Participants will receive vaccinations at the start, after one month, and after four months.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: RandomizationExperimental Treatment2 Interventions
In the randomization phase, twenty-four EBV-seropositive individuals will be randomized in a 1:1 ratio to receive either 3 doses of adjuvanted gH/gL/gp42-ferritin alone or adjuvanted gH/gL/gp42-ferritin + gp350-ferritin nanoparticle. An additional 30 EBV-seronegative individuals will be randomized in a 1:1 ratio to receive either 3 doses of adjuvanted gH/gL/gp42-ferritin alone or adjuvanted gH/gL/gp42 ferritin +gp350-ferritin. Administration of gHgLgp42 ferritin with or without EBV gp350-ferritin will be performed in an open-label fashion.
Group II: Dose escalationExperimental Treatment2 Interventions
In an initial dose escalation phase comprised of 9 EBV seropositive individuals, 3 individuals will receive 50 micrograms adjuvanted gH/gL/gp42 ferritin vaccine alone, then 3 individuals will receive adjuvanted 25 micrograms gH/gL/gp42-ferritin vaccine + 25 micrograms gp350-ferritin vaccine, then 3 individuals will receive adjuvanted 50 micrograms gH/gL/gp42-ferritin vaccine + 50 micrograms gp350-ferritin vaccine.

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Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Findings from Research

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

References

A bivalent Epstein-Barr virus vaccine induces neutralizing antibodies that block infection and confer immunity in humanized mice. [2022]
Immunization with a Self-Assembled Nanoparticle Vaccine Elicits Potent Neutralizing Antibody Responses against EBV Infection. [2021]
Epstein Barr Virus: Development of Vaccines and Immune Cell Therapy for EBV-Associated Diseases. [2021]
Vaccine Development for Epstein-Barr Virus. [2020]
Novel Epstein-Barr virus-like particles incorporating gH/gL-EBNA1 or gB-LMP2 induce high neutralizing antibody titers and EBV-specific T-cell responses in immunized mice. [2018]
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. [2020]
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