Intradermal Influenza Vaccine With Topical Imiquimod in Elderly and Chronic Illness Patients

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and clinical efficacy (death, overall hospitalization, hospitalization for influenza or pneumonia) of ID QIV delivered via an intradermal device with imiquimod cream pretreatment with conventional intramuscular (IM) standard dose QIV and IM high-dose TIV

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Imiquimod; Vaccines

Criteria

Inclusion Criteria:

1. Recruited subjects include subjects ≥50 years or adult subjects ≥18 years with chronic illness attending GOPD or SOPD in HKWC.

2. All subjects/ next of kin give written informed consent.

3. Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

1. Inability to comprehend and to follow all required study procedures.

2. Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.

3. Have a known allergy to eggs or other components of the study vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients.

4. Have an active neoplastic disease or a history of active hematologic malignancy.

4. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.

6. Have known active human immunodeficiency virus (HIV) infection. 7. Received an agent on clinical trial (vaccine, drug, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.

8. Tympanic temperature ≥ 38°C within 3 days of intended study vaccination 9. Have a history of alcohol or drug abuse in the last 5 years. 10. Have a history of Guillain-Barré Syndrome. 11. Pregnant during the study period. 12. Have any condition that the investigator believes may interfere with successful completion of the study.