About the study
This study seeks patients who are thought to have normal immune systems but who have been diagnosed with a viral infection that is unusually severe, prolonged, or persistent. This study will evaluate the participants' immune systems to determine why the infection developed.
If a problem is found that is linked to a particular gene, we may ask if a blood relative(s) would like to participate by submitting their blood for testing. We can determine if a change in a gene is present in other family members.
What does the study involve?
Participants will either be seen as outpatients in our clinic or will be admitted to the National Institutes of Health (NIH) Clinical Center. The number of clinic visits or length of hospital stay will depend on the participant's severity of illness. The study team will take a health history and perform a physical exam. The main research procedures are intermittent blood draws, and in some cases a skin biopsy and/or a swab of the inside of the mouth to study the immune response to the virus that caused the infection. If the participant is not able to come to the Clinical Center, blood samples can be sent in for testing.
We are not studying any particular treatment for viral infections; however, if participants are able to come to the Clinical Center, they will receive treatment with the best available standard of care therapy at no charge.
All study participants will have follow-up visits so we can keep track of their infections. Study participants may be compensated for time and travel.
Where is the study taking place?
The study is being conducted on the NIH campus in Bethesda, Maryland, which is accessible by car and public transportation. Study visits take place on the 11th floor of the NIH Clinical Center during morning and afternoon hours.
Who can participate?
- Children or adults without known immunocompromise and with a definitively diagnosed severe virus infection, including infection caused by herpesviruses (HSV-1, HSV-2, CMV, EBV, VZV, HHV-6, HHV-7, HHV-8), human papillomavirus (e.g., severe recalcitrant warts), adenovirus, polyomavirus (such as JC virus and BK virus), or influenza virus.
- Children or adults with well-documented prior, severe, persistent, or treatment-refractory viral infection(s) who have clinically recovered from the viral infection.
- Children and adults from the groups listed above who are willing to allow storage of blood and tissue samples for future analyses.
To learn more about this study, please visit ClinicalTrials.gov.