Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jan 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine designed to protect against the Epstein-Barr virus (EBV), which is known to cause infectious mononucleosis (often called mono). Mono can lead to long-lasting fatigue and, in some cases, serious health complications. Currently, there are no approved vaccines or treatments for EBV, so this trial aims to see if this new vaccine is safe and effective for people who have never been infected with the virus.

To participate in this trial, you need to be a healthy person aged 18 to 25 years who has never had an EBV infection. Participants will receive two injections of either the vaccine or a placebo (which is just salt water) 30 days apart, and they won't know which one they received. Throughout the study, participants will keep track of any side effects and will have follow-up visits to monitor their health. The trial is not currently recruiting new participants, but if you're interested in participating in future studies, it could be an important opportunity to help advance research on EBV.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• To be eligible to participate in this study, an individual must meet all the following criteria:
• • Aged 18 to 25 years.
• • Able to provide informed consent.
• • Willing to allow samples and data to be stored for future secondary research.
• • Stated willingness to comply with all study procedures and availability for the duration of the active phase of the study (approximately 18 months).
• • In good general health as evidenced by medical history, physical examination, and laboratory screening results.
• • Willing to forgo receipt of a licensed, live vaccine in the 30 days before and 30 days after each dose of the study vaccine. Any FDA-approved or authorized inactivated and/or protein subunit, RNA, or DNA vaccine can be used \>=14 days before or \>=14 days after administration of the study vaccine.
• • 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 within institutional normal reference range, or if not, then deemed not clinically significant by PI or designee.
• • Total lymphocyte count (lymphocyte absolute) \>800 cells/microliters.
• • Platelet count of 125,000 to 500,000/microliters.
• • Alanine aminotransferase \<1.25 x upper limit of normal.
• * Participants who can get pregnant must agree to abstain from sexual activities that can result in pregnancy or use one of the following effective methods of contraception, starting 30 days before the first dose of study vaccine through 60 days after the third dose:
• • 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 efficacy before the first dose of study agent). If the participant uses a contraceptive pill, patch, or ring, then a barrier method (eg, internal/external condom, cervical cap, or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity.
• • A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy.
• • Barrier method (eg, internal/external condom, cervical cap, or diaphragm) plus spermicide used correctly during sexual intercourse.
• • A vasectomy in their monogamous sexual partner completed at least 6 months before the first dose of study vaccine.
• • Continuous abstinence.
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • Pregnant or breastfeeding, or planning to become pregnant while participating through 60 days after the third dose of study vaccine.
• * Has received any of the following:
• • More than 10 days of systemic glucocorticoids (\>=10 mg of prednisone or equivalent) within the 30 days prior to first dose of study agent.
• • More than 10 days of systemic immunosuppressive medications, cytotoxic medications, or immunomodulating therapy within 180 days prior to first dose of study agent.
• • Blood products, including immunoglobulins, within 120 days prior to first dose of study agent.
• • Any live attenuated vaccination within 30 days prior to first dose of study agent.
• • 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.
• * Has any of the following:
• • Febrile illness within 14 days of the first dose of study agent.
• • Body habitus such that identification of the deltoid muscle and/or administration of vaccine into the deltoid would be compromised or if body habitus would make study inclusion not in the best interest of the participant.
• • 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 that required emergency 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.
• • 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.
• • Active hepatitis B or C infection.
• • Documented EBV infection.
• • Prior enrollment in an EBV vaccine clinical trial.
• • 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.
• Co-enrollment guidelines:
• • Co-enrollment in other studies is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the PI or sponsor medical monitor (SMM). Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the PI or SMM.