Understanding immune responses to influenza vaccination in healthy adults
Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults
This study is testing how well the flu vaccine works in healthy adults of different ages to see if their immune responses vary based on when they were born.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (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 | NCT05108818 on ClinicalTrials.gov |
What this trial studies
This study assesses the cellular and humoral immune responses elicited by seasonal influenza vaccination in healthy adults. It aims to enroll up to 100 participants of varying birth years to explore how age-specific differences influence immune responses. The researchers hypothesize that individuals born in different years will exhibit distinct antibody and cellular responses to the vaccine due to prior exposures to influenza viruses. The study will measure these immune responses before and after vaccination to gain insights into vaccine effectiveness across different age groups.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 years and older who can provide informed consent and comply with study procedures.
Not a fit: Patients with known allergies to vaccine components, a history of severe reactions to influenza vaccines, or immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how to optimize influenza vaccination strategies based on age and prior virus exposure.
How similar studies have performed: Other studies have indicated that prior influenza virus exposure can influence immune responses, suggesting that this approach may yield valuable insights.
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 all study visits
3. Aged 18 years and older
4. In good health based on self-reported medical conditions via an online survey
Exclusion Criteria:
1. Known allergic reactions to components of the study vaccine
2. Known latex allergy
3. History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
4. History of GBS within 6 weeks of receipt of a previous influenza vaccine
5. 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
6. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
7. Active 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)
8. Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids
9. Administration of an influenza vaccine within 2 months prior to enrollment
10. Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses
11. Participation in a study that involves an experimental agent or having received an experimental agent (other than a COVID-19 vaccine) within 1 month prior to enrollment or expecting to receive another experimental agent during the study period
12. Intends to donate blood during the study period
13. 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
14. Pregnancy
15. Known human immunodeficiency virus, hepatitis B, or hepatitis C infection
16. Any condition that the principal investigator believes may interfere with successful completion of the study
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — 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.