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InfluenzaPhase 3NCT04143451

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

A Phase 3 study testing Vaxigrip tetra, Fluzone high-dose and Aldara 5% Topical Cream in people with Influenza, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
Vaxigrip tetra, Fluzone high-dose and Aldara 5% Topical Cream
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
1 siteHong Kong
Study dates
23 Oct 2019to 31 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Ivan FN Hung, MD FRCP contact

22554049

ivanhung@hku.hk

Kelvin To, MD FRCPath contact

22553111

kelvinto@hku.hk

Hong Kong1 site, 1 recruiting

  • University of Hong Kong, Queen Mary Hospital

    Hong Kong

    Ivan FN Hung, MD FRCP, 852 22554049, ivanfn@gmail.com

    Kelvin To, MD FRCPath

    Recruiting

Other trials in Hong Kong

About this study

Official title: Intradermal Quadrivalent Influenza Vaccine With Topical Imiquimod in Elderly & Chronic Ill Subjects, a Double-Blind Randomized Controlled Trial

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

Read the detailed description

This is a prospective; double-blind randomized controlled study performed in the HKWC. Recruited subjects include subjects ≥50 years and adult subjects ≥18 years with chronic illness. Eligible subjects will be randomly allocated (3:3:2) into one of the three groups in the first year. Group IQ: topical 5% 250mg imiquimod ointment followed by intradermal QIV, Group IM: topical aqueous-cream followed by IM QIV and Group HD: topical aqueous-cream followed by intramuscular high-dose TIV. Hemagglutination inhibition and neutralization antibody titres will be assayed. We plan to recruit 4000 subjects, 1500 subjects in each of the IQ and IM group (500 subjects in each subgroup with 3 subgroups) and 1000 subjects for the HD group (500 subjects in each subgroup with 2 subgroups).

In the following year, the IQ and IM groups will be further randomized equally into three subgroups: IQ1, IQ2 and IQ3; IM1, IM2 and IM3; and two subgroups for HD group: HD1 and HD2. Subjects randomized to IQ1, IM1 will receive the QIV with the same topical treatment, delivery mode and vaccine as the first year and HD1 will receive the TIV with the same topical treatment, delivery mode and vaccine as the first year. Subgroup IQ2 and IM2 will be vaccinated as follow: IQ2 will receive topical aqueous-cream followed by IM QIV, IM2 will receive topical imiquimod ointment followed by ID QIV. Subgroup IQ3, IM3, HD2 will receive normal saline as the vaccine for that year, but delivered by the same mode and topical treatment. In the third year, subgroups IQ1, IQ2, IM1, IM2 and HD1 will receive the same topical treatment, delivery mode and vaccine as the second year. Subgroup IQ3, IM3 and HD2 will receive the same topical treatment, delivery mode and vaccine as the first year.

Conditions
Influenza
Being tested
Vaxigrip tetra, Fluzone high-dose, Aldara 5% Topical Cream, Aqueous cream BP
Keywords
influenza, intradermal, imiquimod, high-dose, vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaxigrip tetraBiological

    quadrivalent influenza vaccine

  • Fluzone high-doseBiological

    high-dose trivalent influenza vaccine

  • Aldara 5% Topical CreamDrug

    imiquimod cream

  • Aqueous cream BPDrug

    inactive aqueous cream

Study groups in NCT04143451
Study groupRoleWhat they receive
IQActive comparatorYear 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.
Receives: Biological: Vaxigrip tetra; Drug: Aldara 5% Topical Cream
IMActive comparatorYear 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.
Receives: Biological: Vaxigrip tetra; Drug: Aqueous cream BP
HDActive comparatorYear 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.
Receives: Biological: Fluzone high-dose; Drug: Aqueous cream BP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    death rate

    Measured: 3 years

  2. Overall hospitalisation

    hospitalisation rate for all diagnosis

    Measured: 3 years

  3. Hospitalisation for influenza

    hospitalisation rate with microbiological confirmation of influenza

    Measured: 3 years

  4. Hospitalisation for pneumonia

    hospitalisation rate with a clinical diagnosis of pneumonia

    Measured: 3 years

Secondary outcomes (3)

  1. immediate adverse events

    immediate adverse events

    Measured: 5 minutes post vaccination

  2. adverse events

    Local: redness, swelling, induration, pain and ecchymosis. Redness, swelling, and induration will be graded based on size: Grade 1, under 20mm; Grade 2, 20-50mm. Pain will be graded as follows: Grade 1, pain on touch, Grade 2, pain when arm is moved Systemic: fever, headache, malaise, myalgia, arthralgia and severe adverse events.

    Measured: 7 days post vaccination

  3. immunogenicity

    GMT, seroconversion rate, seroprotection rate and GMT fold increase by HI and MN assays on day, 21, 6 months and 1 year

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start23 Oct 2019
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Double blind randomised controlled trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143451
Sponsor's protocol ID
UW 17-372
Status last verified
Apr 2021
First submitted
18 Oct 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vaxigrip tetra, Fluzone high-dose and Aldara 5% Topical Cream in people with Influenza, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ivan FN Hung, MD FRCP (22554049, ivanhung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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