NCT02103023

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

March 28, 2014

Last Update Submit

December 3, 2014

Conditions

Influenza Viral Infections

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate

    Hemagglutination inhibition assay

    Day 7

Secondary Outcomes (8)

  • Seroprotection rate

    Day 7

  • GMT fold increase

    Day 7

  • GMT

    Day 7

  • Seroconversion rate

    Day 21

  • Seroprotection rate

    Day 21

  • +3 more secondary outcomes

Study Arms (4)

ID TIV + imiquimod

EXPERIMENTAL

imiquimod ointment followed by intradermal influenza vaccine

Drug: Imiquimod ointmentBiological: Intradermal influenza vaccine

ID sham + imiquimod

SHAM COMPARATOR

imiquimod ointment followed by sham intradermal influenza vaccine

Drug: Imiquimod ointment

IM TIV + aq

ACTIVE COMPARATOR

aqueous cream followed by intramuscular influenza vaccine

Drug: Aqueous creamBiological: Intramuscular influenza vaccine

ID TIV + aq

ACTIVE COMPARATOR

aqueous cream followed by intradermal influenza vaccine

Drug: Aqueous creamBiological: Intradermal influenza vaccine

Interventions

Imiquimod ointmentDRUG

5% 250mg imiquimod ointment

Also known as: Aldara
ID TIV + imiquimodID sham + imiquimod
Aqueous creamDRUG

aqueous cream

Also known as: Aqueous cream BP
ID TIV + aqIM TIV + aq
Intradermal influenza vaccineBIOLOGICAL

intradermal trivalent influenza vaccine (Intanza15)

ID TIV + aqID TIV + imiquimod
Intramuscular influenza vaccineBIOLOGICAL

intramuscular trivalent influenza vaccine (Vaxigrip)

IM TIV + aq

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (1)

  • 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.

    PMID: 26559482DERIVED

MeSH Terms

Interventions

Imiquimod

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kwok-Yung Yuen, MD FRCP

    The University of Hong Kong

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 3, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

CN(1)