Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists
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|ClinicalTrials.gov Identifier: NCT01737580|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : August 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Influenza Vaccination in Seniors||Drug: resiquimod Drug: placebo gel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists|
|Study Start Date :||April 2013|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Active Comparator: Intanza+resiquimod gel
Intanza 15mcg intradermal injection + resiquimod gel applied to the vaccination site immediately post vaccination.
Other Name: R-848
Placebo Comparator: Intanza + placebo gel
Intanza 15mcg intradermal injection + placebo gel applied to the vaccination site immediately post vaccination.
|Drug: placebo gel|
- Reactogenicity of the vaccine regimens [ Time Frame: Day 0 - Day 28 ]Reactogenicity of the vaccine regimens (Intanza+resiquimod gel; Intanza+placebo gel) will be collected from Day 0 (pre vaccination) to Day 7. The change from Day 0 to Day 7 will be measured. The following information will be collected and compared 1) local pain (none, mild, moderate, severe; 2) injection site redness, swelling, induration measured in millimeters; itchiness present or not 3) bruising; 4) fever-values greater than or equal to 38.0 will be considered fever; 5) general symptoms-shivering, sweating nausea, vomiting diarrhea will be measured for presence or absence; 6) general symptoms-myalgia (muscle aches), arthralgia (joint aches), malaise (feeling unwell), tiredness/fatigue, headache and sleep disturbance will be measured as mild, moderate or severe
- HAI (hemagglutination inhibition)titres [ Time Frame: Day 28 post vaccination ]The primary immunologic outcome will be the 28 day post vaccination immune (HAI, hemagglutination immune assay titer)responses to the 3 vaccine strains present in each vaccine, assessed by the EMEA/CHMP (European Medicines Evaluation/Committee on Human Medicinal Products) Agency criteria for evaluation on immune response to influenza vaccines in persons over 60 years of age. The measurements include seroconversion rate (CHMP threshold greater than 30%), geometric mean titre (GMT) fold-increase or ratio (threshold greater than 2) and seroprotection rate (threshold greater than 60%). Whether the CHMP threshold for each measurement is met or exceeded per strain will be noted between products as descriptive information.
- Granzyme B levels and Interferon gamma to interleukin 10 ratios [ Time Frame: Day 0 and Day 28 post vaccination ]The day 0 (pre vaccination) and day 28 Granzyme B levels and Interferon gamma to interleukin 10 ratios will be measured and the change in levels from Day 0 to Day 28 will be compared in the 2 groups: 1) Intanza+resiquimod gel; 2) Intanza+placebo gel
- Change in Microneutralization titres [ Time Frame: Day 0 and Day 28 post vaccination ]Microneutralization titers will be measured in serum for the 3 virus strains in the influenza vaccine and compared at Day 0 (pre vaccination) and Day 28.
- baseline Granzyme B Activity [ Time Frame: Day 0 and Day 28 post vaccination ]Differences between baseline Granzyme B activity in lysates of PBMC's (peripheral blood mononuclear cells) and Granzyme B levels,interferon gamma to interleukin-10 ratios and HAI (hemagglutination inhibition) titres will be compared.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737580
|Canada, British Columbia|
|University of British Columbia Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Jan P Dutz, MD||University of British Columbia|