HealthyPhase 1NCT06655324
A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).
A Phase 1 study testing V350A and V350B in people with Healthy, run by Merck Sharp & Dohme LLC at 9 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V350A and V350B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Dec 2024to 17 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 6 recruiting
- Recruiting
Remington-Davis, Inc. ( Site 0017)
Columbus, Ohio, 43215
Study Coordinator, 614-487-2560
- Completed
California Clinical Trials Medical Group managed by PAREXEL ( Site 0011)
Glendale, California, 91206
- Recruiting
Alliance for Multispecialty Research, LLC ( Site 0008)
Kansas City, Missouri, 64114
Study Coordinator, 816-943-0770
- Active, not recruiting
Alliance for Multispecialty Research, LLC ( Site 0009)
Knoxville, Tennessee, 37909
- Recruiting
Velocity Clinical Research Lincoln ( Site 0004)
Lincoln, Nebraska, 68510
Study Coordinator, 308-365-8900
- Recruiting
Lynn Health Science Institute ( Site 0010)
Oklahoma City, Oklahoma, 73106
Study Coordinator, 405-602-3939
- Recruiting
Velocity Clinical Research, Omaha ( Site 0005)
Omaha, Nebraska, 68134
Study Coordinator, 402-933-6500
- Active, not recruiting
QPS-MRA, LLC ( Site 0012)
South Miami, Florida, 33143
- Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0016)
Springfield, Missouri, 65802
Study Coordinator, 417-831-2048
About this study
Official title: 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.
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.
- Conditions
- Healthy
- Being tested
- V350A, V350B, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V350ABiological
Vaccination administered via intramuscular injection
V350BBiological
Vaccination administered via intramuscular injection
PlaceboBiological
Vaccination administered via intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| V350A | Experimental | Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6. Receives: Biological: V350A |
| V350B | Experimental | Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6. Receives: Biological: V350B |
| Placebo | Placebo comparator | Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Injection Site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be recorded on a vaccination report card (VRC).
Measured: Up to approximately 6 months
Number of Participants with Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be recorded on a VRC.
Measured: Up to approximately 6 months
Number of Participants with Immediate AEs Following Vaccinations
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be observed following vaccination for immediate AEs.
Measured: Up to approximately 6 months
Number of Participants with Unsolicited AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be recorded on a VRC.
Measured: Up to approximately 7 months
Number of Participants with Serious AEs
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
Measured: Up to approximately 18 months
Number of Participants with Medically Attended Adverse Events (MAAEs)
A MAAE is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs.
Measured: Up to approximately 18 months
Number of Participants with Events of Clinical Interest (ECIs)
ECIs are selected serious and nonserious AEs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
Measured: Up to approximately 18 months
Secondary outcomes (2)
Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens
The GMT of EBV antigen antibody titers will be measured with a multiplex ligand binding assay (LBA).
Measured: Up to approximately 18 months
Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens
The GMFR of EBV antigen antibody titers will be measured with a multiplex LBA.
Measured: Baseline and up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start5 Dec 2024
- Primary completion17 Jul 2028 (estimated)
- Study completion17 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655324
- Sponsor's protocol ID
- V350-001
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06655324
- Acronym / sponsor ID
- V350-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 17 Jul 2028 (estimated)
- Study completion
- 17 Jul 2028 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V350A | Experimental | Biological: V350AParticipants will receive V350A vaccinations on Day 1, Month 2, and Month 6. |
| V350B | Experimental | Biological: V350BParticipants will receive V350B vaccinations on Day 1, Month 2, and Month 6. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo vaccinations on Day 1, Month 2, and Month 6. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V350AVaccination administered via intramuscular injection | Biological | V350A |
| V350BVaccination administered via intramuscular injection | Biological | V350B |
| PlaceboVaccination administered via intramuscular injection | Biological | Placebo |
Primary outcome
Number of Participants with Solicited Injection Site Adverse Events (AEs)
Time frame: Up to approximately 6 months
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be recorded on a vaccination report card (VRC).
Number of Participants with Solicited Systemic AEs
Time frame: Up to approximately 6 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be recorded on a VRC.
Number of Participants with Immediate AEs Following Vaccinations
Time frame: Up to approximately 6 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be observed following vaccination for immediate AEs.
Number of Participants with Unsolicited AEs
Time frame: Up to approximately 7 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be recorded on a VRC.
Number of Participants with Serious AEs
Time frame: Up to approximately 18 months
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Up to approximately 18 months
A MAAE is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs.
Number of Participants with Events of Clinical Interest (ECIs)
Time frame: Up to approximately 18 months
ECIs are selected serious and nonserious AEs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
2 secondary outcomes
Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens
Time frame: Up to approximately 18 months
Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens
Time frame: Baseline and up to approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V350A and V350B in people with Healthy, run by Merck Sharp & Dohme LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Injection Site Adverse Events (AEs) (time frame: Up to approximately 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.