Influenza Vaccination in SeniorsPhase 1NCT01737580
Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists
A Phase 1 study testing resiquimod in people with Influenza Vaccination in Seniors, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination in Seniors
- What is being tested?
- resiquimod
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jun 2013
- Phase
- Phase 1
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
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
- Being tested
- resiquimod, placebo gel
- Keywords
- influenza, human, influenza vaccines, older adults, immune response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resiquimodDrug
Also called R-848
placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Intanza+resiquimod gel | Active comparator | Intanza 15mcg intradermal injection + resiquimod gel applied to the vaccination site immediately post vaccination. Receives: Drug: resiquimod |
| Intanza + placebo gel | Placebo comparator | Intanza 15mcg intradermal injection + placebo gel applied to the vaccination site immediately post vaccination. Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity of the vaccine regimens
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
Measured: Day 0 - Day 28
HAI (hemagglutination inhibition)titres
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.
Measured: Day 28 post vaccination
Granzyme B levels and Interferon gamma to interleukin 10 ratios
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
Measured: Day 0 and Day 28 post vaccination
Secondary outcomes (2)
Change in Microneutralization titres
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.
Measured: Day 0 and Day 28 post vaccination
baseline Granzyme B Activity
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.
Measured: Day 0 and Day 28 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Vaccination in SeniorsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan P Dutz, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737580
- Sponsor's protocol ID
- H12-02574
- Status last verified
- Aug 2013
- First submitted
- 21 Nov 2012
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists
- ClinicalTrials.gov ID
- NCT01737580
- Acronym / sponsor ID
- H12-02574
- Conditions
- Influenza Vaccination in Seniors
- Keywords
- influenza, human, influenza vaccines, older adults, immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intanza+resiquimod gel | Active comparator | Drug: resiquimodIntanza 15mcg intradermal injection + resiquimod gel applied to the vaccination site immediately post vaccination. |
| Intanza + placebo gel | Placebo comparator | Drug: placebo gelIntanza 15mcg intradermal injection + placebo gel applied to the vaccination site immediately post vaccination. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resiquimodAlso: R-848 | Drug | Intanza+resiquimod gel |
| placebo gel | Drug | Intanza + placebo gel |
Primary outcome
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
2 secondary outcomes
Change in Microneutralization titres
Time frame: Day 0 and Day 28 post vaccination
baseline Granzyme B Activity
Time frame: Day 0 and Day 28 post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan P Dutz, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing resiquimod in people with Influenza Vaccination in Seniors, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 13 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 28 Aug 2013. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Reactogenicity of the vaccine regimens (time frame: Day 0 - Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2013.