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

NCT04143451 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: UW 17-372
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Influenza

Keywords

influenza, intradermal, imiquimod, high-dose, vaccine

Outcome Measures

Primary Outcomes (4)

• Mortality

  death rate

  3 years

• Overall hospitalisation

  hospitalisation rate for all diagnosis

  3 years

• Hospitalisation for influenza

  hospitalisation rate with microbiological confirmation of influenza

  3 years

• Hospitalisation for pneumonia

  hospitalisation rate with a clinical diagnosis of pneumonia

  3 years

Secondary Outcomes (3)

• immediate adverse events

  5 minutes post vaccination

• adverse events

  7 days post vaccination

• immunogenicity

  at 21 days, 6 months and 1 year after each vaccination

Study Arms (3)

IQ

ACTIVE COMPARATOR

Year 1: a single dose ID QIV (15 µg of hemagglutinin per strain) with pre-treatment of the injected skin with imiquimod (Aldara) cream Year 2: randomised into 3 subgroups. Group IQ1: ID QIV (15 µg of hemagglutinin per strain) with pre-treatment of the injected skin with imiquimod (Aldara) cream Group IQ2: IM QIV (15 µg of hemagglutinin per strain with pre-treatment of the injected skin with aqueous cream. Group IQ3: ID normal saline vaccination with pre-treatment of the injected skin with imiquimod (Aldara) cream. Year 3: IQ1 and IQ2 same treatment as second year. IQ3 same as first year.

Biological: Vaxigrip tetra; Drug: Aldara 5% Topical Cream

IM

ACTIVE COMPARATOR

Year 1: a single dose IM QIV (15 µg of hemagglutinin per strain) with pre-treatment of the injected skin with aqueous cream Year 2: randomised into 3 subgroups. Group IM1: IM QIV (15 µg of hemagglutinin per strain with pre-treatment of the injected skin with aqueous cream. Group IM2: ID QIV (15 µg of hemagglutinin per strain) with pre-treatment of the injected skin with imiquimod (Aldara) cream. Group IM3: IM normal saline vaccination with aqueous cream pretreatment. Year 3: IM1 and IM2 same treatment as second year. IM3 same as first year.

Biological: Vaxigrip tetra; Drug: Aqueous cream BP

HD

ACTIVE COMPARATOR

Year 1: a single high-dose IM TIV (60 µg of hemagglutinin per strain) with pre-treatment of the injected skin with aqueous cream Year 2: Group HD1: IM QIV (60 µg of hemagglutinin per strain) with pre-treatment of the injected skin with aqueous cream. Group HD2: IM normal saline vaccination with aqueous cream pretreatment. Year 3: Group HD1 same treatment as second year. HD2 same as first year.

Biological: Fluzone high-dose; Drug: Aqueous cream BP

Interventions

Vaxigrip tetra BIOLOGICAL

quadrivalent influenza vaccine

IM; IQ

Fluzone high-dose BIOLOGICAL

high-dose trivalent influenza vaccine

HD

Aldara 5% Topical Cream DRUG

imiquimod cream

IQ

Aqueous cream BP DRUG

inactive aqueous cream

HD; IM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruited subjects include subjects ≥50 years or adult subjects ≥18 years with chronic illness attending GOPD or SOPD in HKWC.
• All subjects/ next of kin give written informed consent.
• 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.

You may not qualify if:

• Inability to comprehend and to follow all required study procedures.
• Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
• 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.
• Have an active neoplastic disease or a history of active hematologic malignancy.
• \. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
• \. 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.
• \. 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Fluzone High-Dose; Imiquimod

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ivan FN Hung, MD FRCP

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan FN Hung, MD FRCP

CONTACT

22554049; ivanhung@hku.hk

Kelvin To, MD FRCPath

CONTACT

22553111; kelvinto@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind randomization will be performed. Only the study nurse has knowledge of the type of topical treatment applied. Subjects and investigators remain blinded to the route and type of vaccination.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Double blind randomised controlled trial

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 29, 2019
• Study Start: October 23, 2019
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)