EBV Vaccine for Healthy Adults

Recruiting at 7 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants

Disqualifiers: Infectious mononucleosis, Immunosuppressive conditions, others

Compensation: Varies

Number of Visits: 3

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new vaccines, V350A and V350B, to determine their safety for healthy adults. The Epstein-Barr virus (EBV) can cause mono and is linked to certain cancers and multiple sclerosis, making prevention important. Participants will receive either V350A, V350B, or a placebo at set intervals to compare results. This trial suits healthy adults who have not recently had mono and are not on immunosuppressive treatments. As a Phase 1 trial, participants will be among the first to receive these new vaccines, aiding researchers in understanding their effects in people.

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.

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

Research has shown that the EBV vaccine, containing the gp350 protein, is safe for healthy adults. Studies have found that this vaccine helps the body produce antibodies to combat the Epstein-Barr virus. Some individuals reported mild side effects, such as soreness at the injection site or a slight fever, after receiving the vaccine. Serious side effects were rare and monitored for up to 210 days post-vaccination. Both V350A and V350B vaccines are administered in three doses, with ongoing research focusing primarily on their safety. Overall, evidence supports the safety of these vaccines in healthy adults. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the EBV vaccines, V350A and V350B, because they represent a proactive approach to preventing Epstein-Barr Virus (EBV) infections, unlike current treatments that primarily focus on managing symptoms. These vaccines aim to stimulate the immune system to recognize and fight EBV before infection can take hold. Most existing EBV management strategies do not prevent the virus itself but rather treat its symptoms or complications. V350A and V350B could potentially offer long-term protection, reducing the incidence of EBV-related diseases. This preventive strategy, if successful, marks a significant advancement in the fight against EBV.

What evidence suggests that this trial's vaccines could be effective for preventing EBV-related diseases?

Research has shown that a similar vaccine, the gp350 vaccine, has been promising in reducing cases of infectious mononucleosis in adults who haven't had EBV before. This suggests that a vaccine against EBV can help lower the risk of this illness. In this trial, participants will receive either the V350A or V350B vaccine, which aim to prevent EBV infection by targeting two types of cells that EBV usually infects: B cells and epithelial cells. This approach could be more effective than earlier vaccines. Early results indicate that this strategy might help prevent diseases related to EBV, but more research is needed to confirm its effectiveness in people. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• V350A
• V350B

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/297408/a-study-to-evaluate-safety-tolerability-and-immunogenicity-of-v350a-and-v350b-in-healthy-participants-v350-001/

A Study to Evaluate Safety, Tolerability, and ... The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults. Eligibility. Inclusion Criteria:.

2. withpower.com withpower.com/trial/ebv-vaccine-for-healthy-adults-55fe1

EBV Vaccine for Healthy Adults 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 ...

3. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06655324/

A Study to Evaluate Safety, Tolerability, and Immunogenicity of ... The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults. View full trial information on Clinicaltrials.

4. trial.medpath.com trial.medpath.com/news/cc0c1b3eb1e56ba2/opko-health-s-modex-therapeutics-announces-epstein

ModeX Therapeutics' Epstein-Barr Virus Vaccine Enters ... This multi-targeted approach aims to inhibit EBV infection in both B cells and epithelial cells, contrasting with earlier vaccine candidates ...

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

Recent Progress in the Vaccine Development Against ... It might suggest that the EBV vaccine effectively reduced the infection but did not prevent it. The negative data from the adult group might be due to previous ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04645147

NCT04645147 | Safety and Immunogenicity of an Epstein- ... Unsolicited adverse events up to 30 days after each vaccination; Serious adverse events through Day 210; Change in log10 antibody response to EBV from baseline ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4072744/

Progress, Prospects, and Problems in Epstein-Barr Virus ... After the vaccine was shown to be safe in 11 adults and 6 children who were latently infected by EBV, 19 EBV-naïve children 1 to 3 years of age ...