An observational study to learn more about infectious mono is enrolling near you
You or your teenager may be eligible to join
Infectious mononucleosis (commonly called “mono”) is a viral infection caused by the Epstein-Barr virus (EBV). This observational study aims to learn more about how EBV infection develops, and how it affects people from different age groups. We are looking for high school and university volunteers.
People who take part will receive compensation in the form of an electronic gift card for their travel and study related expenses.
About the CIRCLE-EBV StudyWhat is the CIRCLE-EBV Study?
The CIRCLE-EBV Study is an observational study that aims to understand how infection by the Epstein-Barr virus (EBV) develops. It also aims to learn more about how this viral infection affects people from different age groups.
In the CIRCLE-EBV Study, we will collect information through blood and saliva samples, health questionnaires, and regular study visits. No treatments or vaccines are being tested in this study. It is hoped that your or your teenager’s participation in this study will provide valuable data that could help develop vaccines and treatments against EBV in the future.
About EBV
Epstein-Barr virus (EBV) is a very common virus that infects most people at some point in their lives. EBV is spread through saliva, and it is possible to catch it from activities like sharing eating utensils and food, and kissing. Most cases of EBV infection do not cause symptoms. However, in adolescents and young adults, it can cause an illness called infectious mononucleosis (also known as "mono"). EBV is the most common cause of mono.
About mono
Symptoms of infectious mononucleosis, or mono, can range from mild to serious, and appear 4–8 weeks after exposure to EBV. Someone who has mono may have symptoms such as:
- Fatigue
- Sore throat
- Stomach pain or discomfort
- Headache
- Nausea
- Rash
- Fever or feeling hot (38°C/100.4°F or higher)
- Body aches (joint and/or muscle aches)
- Cough
- Excessive sleeping
- Swollen and/or painful lymph nodes
Healthcare providers can confirm if someone has mono with blood tests. Antibiotics and antivirals don’t work on mono. Most people who get mono from EBV only get it once, and mono often goes away after 2–4 weeks.
CIRCLE-EBV Study quick facts
Eligible participants will need to attend study visits regularly for as long as they are in the study. Study participation will last up to 4 years for high school students and up to 6 years for university students.
Several tests and assessments will be performed to monitor a participant’s health. These will include:
Questionnaires and interviews about their lives, their health, and the health of their families
Questionnaires about any symptoms related to mono
Physical examinations
Measurements of vital signs (blood pressure, heart rate, breathing rate, and temperature, etc.)
Blood tests
Saliva tests
What to expect in the CIRCLE-EBV Study
Study periods
1
Screening period
Up to 2 weeks
Potential participants will have a blood test to see if they have had EBV in the past. They will also answer some questions about themselves and their family. If blood tests show that potential participants have not had EBV in the past, they will attend an enrollment visit and subsequently join the regular follow-up study period.
2
Regular follow-up period
Participants will:
- complete periodic study visits
- report any possible symptoms of mono they experience.
Additional follow-up visits will be needed if the participant is infected with EBV during the study.
We will keep a close eye on you or your teenager’s health and any symptoms of mono you/they may have.
What are clinical studies?
Clinical studies can help us learn about medications, treatments, diseases, and health conditions.
Some studies look at whether a potential new, investigational medication or treatment can work, or how safe it is. These are called interventional studies.
Other studies may look at how a medication or treatment works in the real world, after being approved for use. Or they might collect information about specific diseases or medical conditions. These studies are usually called observational studies, or non-interventional studies.
What are observational studies?
Observational studies are a type of research study. They help identify patterns, such as how social or health backgrounds affect each participant’s health over time. Taking part in an observational study does not impact participants’ existing medical care. This means any potential drugs, tests, or procedures will not change due to participation in this study.
In this study, we will not be testing any treatments or vaccines. Instead, we will collect information through blood and saliva samples, health questionnaires, and regular study visits. We hope that participation in this study will help us collect valuable information that may help develop vaccines or treatments against EBV in the future.
What is it like to be in an observational study?
If someone joins an observational study, they would:
- keep doing any usual activities
- continue their usual healthcare, and
- answer some questions about their health and daily activities, or undergo study tests and assessments.
Why are observational studies important?
Observational studies are important because they may help us better understand how diseases, medications, or treatments affect people in a real-life setting.
By combining the findings from different observational studies, healthcare professionals may be able to recommend the best practices for patients.
Why should someone consider taking part in an observational study?
By sharing their experiences, participants can potentially make a meaningful impact and help shape the future of healthcare in their community.
What happens after a decision is made to take part in the study?
If you would like to know whether you or your teenager might be able to take part in the study, please contact a participating research study center in your area. Please note: during the screening process, the study team will check additional criteria to make sure someone can join the study.
Is there a cost to take part?
There is no cost to participate in this study. Participants may receive compensation for study-related travel and expenses.
How can someone make an informed decision?
Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study. If the potential study participant is under the age of consent, a legally authorized representative (LAR) or parent/guardian will provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.
The success of studies – including observational studies – depends on people who are willing to participate. Together with the research team, each participant may help advance medical research, potentially benefiting others and future generations.
If you or your teenager are considering joining an observational study, consider these points to make an informed decision:
- Time commitment: Know how long the study lasts and how long each visit takes (including travel to get there). It is important to try to complete the entire study because early dropouts can affect the results.
- Understanding the study: Make sure you or your teenager understand the purpose of the study, what is expected of participants, and the potential benefits and risks involved.
- Why am I considering enrolling: Think about why you or your teenager want to join the study. Having a clear reason can help participants stay committed.
As a study participant, how can I access the Health Research Space (HRS) portal?
To access HRS, please visit https://circleebv.ihp.iqvia.com and use your participant login details to sign in.