Clinical trial NCT01737580: Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists
Official title: Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza Vaccination in Seniors
Keywords: influenza, human
influenza vaccines
older adults
immune response
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The application of the TLR7/8 (Toll Like Receptor) agonist gel (immune response helper) resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors 65-75 years of age.


Eligibility criteria: Inclusion Criteria:

* written informed consent provided by the subject, who can be male or female
* subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations and able to converse with study personnel including by personal telephone
* male or female age 65-75 years at visit 1
* in generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (clinical frailty score 1-5) and able to attend clinic appointments
* receipt of influenza vaccination for the 2012-2013 influenza season

Exclusion Criteria:

* receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of visit 1 or planned administration of any non-study vaccines between visits 1 and 2
* systemic hypersensitivity to influenza vaccine, hen's eggs or other vaccine constituent e.g. neomycin sulphate, kanamycin, formalin
* severe reaction to any previous influenza vaccine or vaccine component
* bleeding disorder, including anticoagulant therapy or thrombocytopenia, that contraindicates IM (intramuscular) injection or blood collection (does not include daily low dose ASA (acetylsalicylic acid), Plavix, and certain other mild anticoagulants with minimal bleeding risk)
* incapacity to provide fully informed consent or be attentive to follow-up observations, resulting from cognitive impairment, abuse of alcohol, or drug addiction
* lack of telephone access, inadequate fluency in English, uncertain availability during the 4 week study participation
* immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months of visit 1
* receipt of blood or blood products within 3 months of visit 1
* unstable medical conditions, as indicated by a requirement for hospitalization or a substantial medication change to stabilize said condition within 3 months.
* personal frailty, determined by Clinical Frailty score of 6-7 (moderately frail or severely frail)or failure on the TUG test (Timed Up and Go time greater than 10 seconds) or inability to walk 1/4 mile, based on self report
* history of Guillain-Barre Syndrome
* psoriasis
* recent or current febrile illness with oral temperature greater or equal to 38.0 degrees centigrade or other moderate to severe illness within the previous 48 hours (may vaccinate once condition has resolved)

Primary outcomes:
measure: Reactogenicity of the vaccine regimens
timeFrame: Day 0 - Day 28
measure: HAI (hemagglutination inhibition)titres
timeFrame: Day 28 post vaccination
measure: Granzyme B levels and Interferon gamma to interleukin 10 ratios
timeFrame: Day 0 and Day 28 post vaccination
Secondary outcomes:
measure: Change in Microneutralization titres
timeFrame: Day 0 and Day 28 post vaccination
measure: baseline Granzyme B Activity
timeFrame: Day 0 and Day 28 post vaccination
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jan P Dutz, MD
role: PRINCIPAL_INVESTIGATOR
References: