Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists

NCT ID: NCT01737580

Last Updated: 2013-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Influenza Vaccination in Seniors

Keywords

influenza, human; influenza vaccines; older adults; immune response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intanza+resiquimod gel

Intanza 15mcg intradermal injection + resiquimod gel applied to the vaccination site immediately post vaccination.

Group Type: ACTIVE_COMPARATOR

resiquimod

Intervention Type: DRUG

Intanza + placebo gel

Intanza 15mcg intradermal injection + placebo gel applied to the vaccination site immediately post vaccination.

Group Type: PLACEBO_COMPARATOR

placebo gel

Intervention Type: DRUG

Interventions

resiquimod

Intervention Type: DRUG

placebo gel

Intervention Type: DRUG

Other Intervention Names

R-848

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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan P Dutz, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H12-02574

Identifier Type: -

Identifier Source: org_study_id