BridgeMD
New treatment option for EBV
Official title Epstein-Barr Virus (EBV) gH/gL/gp42-Ferritin Nanoparticle Vaccine With or Without gp350-Ferritin in Healthy Adults With or Without EBV Infection
ClinicalTrials.gov ID: NCT06908096
What this study is testing
What is EBV gp350-ferritin vaccine with ALFQ adjuvant?
EBV gp350-ferritin vaccine with ALFQ adjuvant is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for ebv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 17 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 29. Healthy volunteers may be eligible.
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- 18 to 29 years old.
- Able to provide informed consent.
- Willingness to allow storage of blood and saliva for future research.
- In good general health as evidenced by medical history, physical examination, and laboratory screening results.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant, breastfeeding, or planning to become pregnant while participating through 60 days after the last dose of vaccine.
- Participant has received any of the following:
- More than 10 days of systemic immunosuppressive medications (\>=10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days...
- Blood products, including immunoglobulin products, within 120 days prior to first dose of vaccine.
- Investigational research agents within 30 days prior to first dose or planning to receive investigational products while on study.
See the full eligibility criteria
Who can join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- 18 to 29 years old.
- Able to provide informed consent.
- Willingness to allow storage of blood and saliva for future research.
- In good general health as evidenced by medical history, physical examination, and laboratory screening results.
- Participant is willing to forgo receipt of a licensed, live vaccine in the 30 days preceding each dose of vaccine or in the 30 days following each dose of vaccine. Any FDA-approved inactivated, subunit, or...
- Participants of reproductive potential who are sexually active with a partner who can impregnate them: use of highly effective continuous contraception for at least 30 days prior to Day 0 and agreement to continue use...
- Intrauterine device (IUD) or equivalent.
- Hormonal contraceptive (eg, consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full how well it works prior to dosing). If the participant uses a...
- A stable, long-term monogamous relationship with a partner who does not pose any potential pregnancy risk, eg, has undergone a vasectomy at least 6 months prior to the first dose of vaccine or is of the same sex as the...
- A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy. Acceptable forms of contraception for participants who can impregnate a partner include one of the following:
- External condom plus spermicide, used during sexual intercourse, even if the partner uses a contraceptive pill, patch, or ring.
- A vasectomy completed at least 6 months before the first dose of vaccine.
- Continuously and completely abstaining from sexual intercourse with a partner of childbearing potential from the first dose of vaccine until 30 days after the last dose. Acceptable contraception for partners of...
- IUD or equivalent.
- Hormonal contraceptive (eg, pill, patch, ring, implant, or an injection used consistently and that has reached full effect prior to the first dose of vaccine).
- Hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy. Laboratory Criteria within 30 days or less prior to enrollment:
- Hemoglobin within institutional normal limits or if not, then assessed and deemed not clinically significant by PI or designee
- White blood cell count and differential either within institutional normal reference range or if not then assessed and deemed not clinically significant by PI or designee
- Total lymphocyte count (lymphocyte absolute) \> 800 cells/microL
- Platelet count equal to 125,000-500,000/microL
- Alanine aminotransferase \<1.25 x upper limit of normal (ULN)
- Serum IgG \>600 mg/dL
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant, breastfeeding, or planning to become pregnant while participating through 60 days after the last dose of vaccine.
- Participant has received any of the following:
- More than 10 days of systemic immunosuppressive medications (\>=10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days prior to first dose of vaccine or immunomodulating therapy within 180...
- Blood products, including immunoglobulin products, within 120 days prior to first dose of vaccine.
- Investigational research agents within 30 days prior to first dose or planning to receive investigational products while on study.
- Allergy treatment with antigen injections, unless on a maintenance schedule of shots no more frequently than once per month.
- Prior participant in an EBV vaccine clinical trial.
- Participant has any of the following:
- Febrile illness within 14 days of the first dose of vaccine.
- Body habitus such that it is difficult to confirm location of the deltoid muscle for safe intramuscular injection.
- History of serious reactions to vaccines.
- Hereditary, acquired, or idiopathic forms of angioedema.
- Idiopathic urticaria within the past year.
- Asthma that is not well-controlled or required emergent care, urgent care, hospitalization, or intubation during the past 2 years or that requires the use of oral or intravenous steroids.
- Diabetes mellitus type 1 or type 2, excluding a history of gestational diabetes.
- Clinically significant autoimmune disease or immunodeficiency.
- Hypertension that is not well-controlled.
- Thyroid disease that is not well-controlled.
- Bleeding disorder diagnosed by doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
- Significant bruising or bleeding difficulties with intramuscular injections or blood draws.
- Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure or malignancy that is likely to recur during the study period.
- Seizure disorder other than a history of 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the past 3 years.
- Asplenia, functional asplenia, or any condition resulting in absence or removal of the spleen.
- History of Guillain-Barre Syndrome.
- Alcohol or drug abuse or addiction.
- HIV infection.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 17 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 29 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.