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AzTrials

Influenza Viral InfectionsPhase 3NCT02103023

Intradermal Influenza Vaccine in the Young

A Phase 3 study testing Imiquimod ointment, Aqueous cream and Intradermal influenza vaccine in people with Influenza Viral Infections, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Influenza poses a heavy burden to our health service. The WHO estimates that seasonal influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Influenza Viral Infections
What is being tested?
Imiquimod ointment, Aqueous cream and Intradermal influenza vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteChina
Study dates
Mar 2014to Nov 2014
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 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • All adult patients at the age of 18-30 years and given 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

  • Clinically significant immune-related diseases or significant recent co-morbidities
  • Inability to comprehend and to follow all required study procedures
  • History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
  • Have received trivalent influenza vaccine within the same year
  • 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.
Show all 19Show fewer
  • Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
  • Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control measures during the first 3 weeks after vaccination.
  • Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
  • Have an active neoplastic disease or a history of any hematologic malignancy.
  • Have long-term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed).
  • 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), Hepatitis C infection or autoimmune hepatitis and cirrhosis.
  • Received an experimental agent (vaccine, drug, biologic, 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.
  • History of progressive or severe neurological disorders Have received any licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination (only exception being unadjuvanted seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations).
  • Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination
  • Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule
  • Have a history of alcohol or drug abuse in the last 5 years.
  • Have a history of Guillain-Barré Syndrome. Have any condition that the investigator believes may interfere with successful completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong, Hong Kong

Other trials in China

About this study

Official title: Intradermal Trivalent Influenza Vaccine in Young Adults, a Double-blind Randomized Controlled Trial

Influenza poses a heavy burden to our health service. The WHO estimates that seasonal influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity. Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza virus in mouse model. The objective of this prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal influenza vaccination in healthy young adults.

Read the detailed description

Influenza poses a heavy burden to our health service. Seasonal, zoonotic and pandemic influenza are constant global threats. The WHO estimates that seasonal influenza causes 250,000-500,000 deaths worldwide each year, with an even higher mortality during the pandemic periods. Moreover zoonotic influenza such as the avian-origin H5N1 and more recently the H7N9 influenza are associated with a much higher mortality than seasonal influenza. Vaccine immunogenicity among elderly individuals is also suboptimal due to immunosenescence. Various strategies including intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity.

Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza virus in both mouse model. The objective of this prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal influenza vaccination. Our a priori hypothesis is that imiquimod pretreatment would expedite and augment the immunogenicity of influenza vaccination.

Being tested
Imiquimod ointment, Aqueous cream, Intradermal influenza vaccine, Intramuscular influenza vaccine

What participants receive

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

  • Imiquimod ointmentDrug

    Also called Aldara

    5% 250mg imiquimod ointment

  • Aqueous creamDrug

    Also called Aqueous cream BP

    aqueous cream

  • Intradermal influenza vaccineBiological

    intradermal trivalent influenza vaccine (Intanza15)

  • Intramuscular influenza vaccineBiological

    intramuscular trivalent influenza vaccine (Vaxigrip)

Study groups in NCT02103023
Study groupRoleWhat they receive
ID TIV + imiquimodExperimentalimiquimod ointment followed by intradermal influenza vaccine
Receives: Drug: Imiquimod ointment; Biological: Intradermal influenza vaccine
ID sham + imiquimodSham comparatorimiquimod ointment followed by sham intradermal influenza vaccine
Receives: Drug: Imiquimod ointment
IM TIV + aqActive comparatoraqueous cream followed by intramuscular influenza vaccine
Receives: Drug: Aqueous cream; Biological: Intramuscular influenza vaccine
ID TIV + aqActive comparatoraqueous cream followed by intradermal influenza vaccine
Receives: Drug: Aqueous cream; Biological: Intradermal influenza vaccine

What is being measured

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

  1. Seroconversion rate

    Hemagglutination inhibition assay

    Measured: Day 7

Secondary outcomes (8)

  1. Seroprotection rate

    Hemagglutination inhibition assay

    Measured: Day 7

  2. GMT fold increase

    Hemagglutination inhibition assay

    Measured: Day 7

  3. GMT

    Microneutralization antibody assay

    Measured: Day 7

  4. Seroconversion rate

    Hemagglutination inhibition assay

    Measured: Day 21

  5. Seroprotection rate

    Hemagglutination inhibition assay

    Measured: Day 21

  6. GMT fold increase

    Hemagglutination inhibition assay

    Measured: Day 21

  7. GMT

    Microneutralization antibody assay

    Measured: Day 21

  8. Adverse events

    Solicited local and systemic adverse reactions monitored from time of vaccination till day 7.

    Measured: Day 7

Timeline

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

  1. First posted3 Apr 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02103023
Sponsor's protocol ID
UW 14-016
Status last verified
Dec 2014
First submitted
28 Mar 2014
Last updated
5 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Hung IF, Zhang AJ, To KK, Chan JF, Li P, Wong TL, Zhang R, Chan TC, Chan BC, Wai HH, Chan LW, Fong HP, Hui RK, Kong KL, Leung AC, Ngan AH, Tsang LW, Yeung AP, Yiu GC, Yung W, Lau JY, Chen H, Chan KH, Yuen KY. Topical imiquimod before intradermal trivalent influenza vaccine for protection against heterologous non-vaccine and antigenically drifted viruses: a single-centre, double-blind, randomised, controlled phase 2b/3 trial. Lancet Infect Dis. 2016 Feb;16(2):209-18. doi: 10.1016/S1473-3099(15)00354-0. Epub 2015 Nov 9.

    PubMed 26559482

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Imiquimod ointment, Aqueous cream and Intradermal influenza vaccine in people with Influenza Viral Infections, run by The University of Hong Kong at 1 site in China.

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 19 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: finished, as of the sponsor's last update on 5 Dec 2014. 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 China. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (time frame: Day 7). 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 NCT02103023, which also lists 1 linked publication.

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 5 Dec 2014.

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