Evaluating a new vaccine for Epstein Barr virus in healthy adults
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants.
This study is testing two new vaccines for the Epstein Barr virus in healthy adults to see if they are safe and effective at preventing related diseases.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 12 Years to 30 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 9 sites (Glendale, California and 8 other locations) |
| Trial ID | NCT06655324 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and immunogenicity of two new vaccine candidates, V350A and V350B, in healthy adult participants. The research focuses on understanding how well these vaccines can be tolerated and their potential effectiveness in preventing diseases associated with the Epstein Barr virus (EBV). Participants will be randomly assigned to receive either the vaccine or a placebo, and their health will be monitored throughout the study. The goal is to gather important data that could lead to new preventive measures against EBV-related diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 35.
Not a fit: Patients with a history of infectious mononucleosis or those with immunosuppressive conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new vaccine that helps prevent diseases linked to Epstein Barr virus.
How similar studies have performed: While this approach is novel in the context of EBV vaccines, similar vaccine studies have shown promise in other viral infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization. * Has a body mass index between 18 and 38 kg/m\^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m\^2, inclusive, for adolescents 12-17. Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a confirmed or suspected case of infectious mononucleosis within 12 months prior to enrollment. * Has any immunosuppressive medical condition or receive any immunosuppressive therapy.
Where this trial is running
Glendale, California and 8 other locations
- California Clinical Trials Medical Group managed by PAREXEL ( Site 0011) — Glendale, California, United States (Completed)
- QPS-MRA, LLC ( Site 0012) — Miami, Florida, United States (Active_not_recruiting)
- Alliance for Multispecialty Research, LLC ( Site 0008) — Kansas City, Missouri, United States (Recruiting)
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016) — Springfield, Missouri, United States (Recruiting)
- Velocity Clinical Research Lincoln ( Site 0004) — Lincoln, Nebraska, United States (Recruiting)
- Velocity Clinical Research, Omaha ( Site 0005) — Omaha, Nebraska, United States (Active_not_recruiting)
- Remington-Davis, Inc. ( Site 0017) — Columbus, Ohio, United States (Recruiting)
- Lynn Health Science Institute ( Site 0010) — Oklahoma City, Oklahoma, United States (Recruiting)
- Alliance for Multispecialty Research, LLC ( Site 0009) — Knoxville, Tennessee, United States (Active_not_recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.