EBV Vaccine for Healthy Adults

Recruiting at 6 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants

Disqualifiers: Infectious mononucleosis, Immunosuppressive conditions, others

Trial Summary

What is the purpose of this trial?

Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapy, you may not be eligible to participate.

What data supports the effectiveness of the EBV vaccine treatment for healthy adults?

The EBV vaccine, which includes the gp350 protein, has shown to be safe and can trigger an immune response in healthy adults, producing antibodies that target the virus. In a phase 2 trial, a similar vaccine reduced the occurrence of infectious mononucleosis, a disease caused by EBV, although it did not prevent the virus itself from infecting people. ^{1 2 3 4 5}

How does the EBV vaccine V350A, V350B differ from other treatments for Epstein-Barr virus?

The EBV vaccine V350A, V350B is unique because it uses a recombinant subunit of the gp350 protein from the Epstein-Barr virus to stimulate an immune response, which is different from other treatments that may not target this specific protein. This vaccine aims to prevent infectious mononucleosis and potentially reduce the risk of EBV-associated cancers, whereas no other standard vaccines are currently available for these conditions. ^{1 2 3 6 7}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy adults with a BMI between 18 and 35. Participants should not have had infectious mononucleosis in the past year or any condition that weakens the immune system, nor should they be on immunosuppressive therapy.

Inclusion Criteria

Is in good health before randomization

My BMI is between 18 and 35.

Exclusion Criteria

I have a condition or take medication that weakens my immune system.

I have had mono in the last year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive V350A, V350B, or placebo vaccinations on Day 1, Month 2, and Month 6

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• V350A (Virus Therapy)
• V350B (Virus Therapy)

Trial Overview The study is testing two new vaccines, V350A and V350B, against a placebo to prevent diseases related to Epstein Barr virus (EBV), which can cause mononucleosis and is linked to certain cancers and multiple sclerosis.

Participant Groups

Group I: V350B Experimental Treatment 1 Intervention

Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.

Group II: V350A Experimental Treatment 1 Intervention

Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

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]

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]

A candidate vaccine containing the EBV glycoprotein gp350 has shown promise in protecting cottontop tamarins from EBV lymphoma, indicating potential efficacy in preventing EBV-related malignancies.

In a phase 2 trial with humans, the gp350 vaccine reduced the incidence of infectious mononucleosis in EBV seronegative adults, although it did not prevent EBV infection itself, highlighting challenges in developing effective vaccines against EBV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need and challenges for development of an Epstein-Barr virus vaccine. Cohen, JI., Mocarski, ES., Raab-Traub, N., et al.[2021]

A phase 2 trial of an Epstein-Barr virus (EBV) gp350 vaccine showed it could reduce the rate of infectious mononucleosis (IM), but it did not prevent the actual virus infection.

There is potential for therapeutic vaccines targeting EBV-associated malignancies, as infusing EBV-specific T cells has shown effectiveness in reducing diseases like Hodgkin lymphoma and nasopharyngeal carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epstein-barr virus vaccines. Cohen, JI.[2022]

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]

The recombinant EBV subunit vaccine (gp350/AS04) demonstrated a significant efficacy rate of 78.0% in preventing infectious mononucleosis among 181 healthy young adults, although it did not prevent asymptomatic EBV infections.

The vaccine was well-tolerated, with no safety concerns reported, and resulted in a high seroconversion rate of 98.7% for anti-gp350 antibodies, which persisted for over 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults. Sokal, EM., Hoppenbrouwers, K., Vandermeulen, C., et al.[2022]

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]

References

1. Netherlands 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. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Vaccine Development for Epstein-Barr Virus. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The need and challenges for development of an Epstein-Barr virus vaccine. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Epstein-barr virus vaccines. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A cohort study among university students: identification of risk factors for Epstein-Barr virus seroconversion and infectious mononucleosis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults. [2022]

7. United States 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. [2020]