Assessing immune responses in individuals with influenza infection
Evaluating Immune Imprinting in the Context of Influenza Virus Infections
This study is trying to see how people's immune systems react to the flu based on their past infections, by looking at samples from individuals who currently have the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06807840 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the cellular and humoral immune responses in individuals who have an active influenza infection. Researchers will longitudinally collect serum, peripheral blood mononuclear cells (PBMC), and respiratory samples from participants to characterize how prior influenza exposures influence immune responses. The study will enroll up to 50 participants each year, focusing on understanding the role of memory immune responses versus new immune responses elicited by influenza infections. The findings could provide insights into how previous infections shape immunity against newer viral strains.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who have tested positive for influenza within the University of Pennsylvania Health System.
Not a fit: Patients with known immunosuppression, pregnancy, or certain neoplastic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of immune responses to influenza, potentially leading to improved vaccine strategies.
How similar studies have performed: While this study builds on previous findings regarding immune responses to influenza vaccinations, the specific focus on active infections and their immune implications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Aged 18 years and older
4. Influenza positive test result performed within the University of Pennsylvania Health System
Exclusion Criteria:
1. Known latex allergy
2. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
3. Pregnancy due to the volume of blood collected in this study
4. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
5. Any neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy ("active" is defined as having received treatment within the past 5 years)
6. Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would interfere with the evaluation of immune responses
7. Intends to donate blood during the study period
8. A known human immunodeficiency virus, hepatitis B, or hepatitis C infection
9. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
10. Prolonged inpatient hospitalization that disrupts or interferes with study procedures.
11. Weigh less than 110lbs
Where this trial is running
Philadelphia, Pennsylvania
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Scott Hensley, PhD
- Email: hensley@pennmedicine.upenn.edu
- Phone: 215-573-3756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.