Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Aims and hypotheses to be tested:

Primary objective

• To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders.

Secondary objectives

• To determine the IIV non-responder rate in healthy Hong Kong children.

• To investigate the association between HLA molecules and IIV non-responsiveness.

Hypotheses

• We hypothesize that among IIV non-responder children, the seroconversion rate after ID IIV with topical imiquimod will be significantly higher than a second IM IIV dose.

• We hypothesize that the IIV non-responder rate is approximately 5-10% in the paediatric population.

• We hypothesize that certain HLA alleles are associated with IIV non-responders.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Age 8-18 years old

• Subjects receiving IIV influenza vaccination through the Seasonal Influenza Vaccination School Outreach Programme.

Exclusion Criteria:

• Age <8 years old to avoid the need for second dose vaccine in case the subjects have never had influenza vaccines before

• Age >18 years old

• Received any forms of influenza vaccines, including the intranasal live-attenuated influenza vaccines or inactivated vaccines, in the past six months

• Underlying chronic illnesses, including immunodeficiencies or autoimmune diseases

• Using immunosuppressive reagents, such as long-term corticosteroids, and other steroid-sparing reagents 6 months prior to the recruitment

• Received intravenous immunoglobulin or other blood products 3 months prior to the recruitment

• Had upper respiratory tract infection symptoms within two weeks before the vaccination, including fever, cough, sore throat, and coryza

• Previous allergic reactions to imiquimod, influenza vaccines, and their excipients.