InfluenzaNCT01232868
Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly
A study testing trivalent Influenza vaccine (TIV) in people with Influenza, run by Emory University at 1 site in United States.
Trial summary
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- trivalent Influenza vaccine (TIV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals aged 25-40 years, or ≥65 years old.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after trivalent Influenza vaccination.
Who cannot join
- Receipt of immune products:
- Receipt of blood products 3 months prior to study entry or expected receipt through 6 months after study entry
- Receipt of any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*
- Receipt of any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*
- Receipt of the 2010-2011 influenza vaccine
- Documented influenza infection during the 2010-2011 influenza season. Not excluded from the study, volunteers with prior upper respiratory infections during the 2010-2011 influenza illness.
Show all 21Show fewer
- Presence of co-morbidities or immunosuppressive states such as:
- Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, auto immune diseases, severe gastrointestinal diseases, and uncontrolled hypertension.
- Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; cancer; current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy [i.e. more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months*; receipt of high-dose inhaled steroids is also an exclusion criteria (nasal and topical steroids are allowed.)], congenital immunodeficiency, anatomical or functional asplenia.
- Pregnancy or breast feeding
- Conditions that could affect the safety of the volunteers such as:
- Severe reactions to prior vaccination with TIV, including anaphylaxis.
- History of Guillain Barré syndrome
- History of bleeding disorders
- Any allergy to any component of the vaccine including egg allergy.
- Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0C], regardless of the route) within 3 days prior to study entry *.
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
- Note:
- An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
- Subjects receiving > 10 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
About this study
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.
In this trial, the investigators will study the immunologic differences of an FDA approved licensed influenza vaccine between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65 will be enrolled in the study. Each participant in the study will be given one flu shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.
Read the detailed description
RATIONALE:Trivalent Influenza vaccine (TIV) is known to induce diminished functional antibody responses and lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in innate responses which translates into suboptimal Hemagglutination Inhibition Assay (HAI) titers. Therefore, early innate signatures of vaccination should correlate with, and predict the immunogenicity of TIV in the young and elderly.
STUDY DESIGN: Single center, open label study in which adult healthy volunteers with no contraindications to immunization will be vaccinated with TIV. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30, D180 post vaccination to study innate and/or adaptive immunity markers. Even though influenza vaccination is considered safe, volunteers will be asked to report any local or systemic adverse events (AEs) from Day 0 (vaccination) to Day 7 in memory aids. Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Volunteers will be also asked to report local and systemic AEs developing the day of a blood draw.
Additionally, only AEs considered related (unlikely, possibly, probably or definitely related) will be collected and reported in this study from Day 0 (vaccination) to Day 180. After Day 30 only related SAEs will be collected and reported.
- Conditions
- Influenza
- Being tested
- trivalent Influenza vaccine (TIV)
- Keywords
- Innate immunity, Adaptive immunity, Slu shot, Elderly
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent Influenza vaccine (TIV)Biological
Also called Fluzone
0.5 ml IM as a single dose in a prefilled syringe.
| Study group | Role | What they receive |
|---|---|---|
| Age 25-40 | Other | Trivalent Influenza vaccine given to age 25-40 Receives: Biological: trivalent Influenza vaccine (TIV) |
| Age ≥65 | Other | Trivalent Influenza vaccine given to age≥65 Receives: Biological: trivalent Influenza vaccine (TIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures
The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.
Measured: Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)
Secondary outcomes (1)
Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures
The secondary outcomes will identify the number of participants with a positive B cell response to the flu shot particulary looking for antibody responses, presence of plasmablasts, antibody repertoire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232868
- Sponsor's protocol ID
- IRB00046787
- Other IDs
- NIH, VAX-001
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2010
- Last updated
- 30 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly
- ClinicalTrials.gov ID
- NCT01232868
- Acronym / sponsor ID
- IRB00046787
- Conditions
- Influenza
- Keywords
- Innate immunity, Adaptive immunity, Slu shot, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 30 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.
In this trial, the investigators will study the immunologic differences of an FDA approved licensed influenza vaccine between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and forty four healthy volunteers above the age of 65 will be enrolled in the study. Each participant in the study will be given one flu shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.
Detailed description
RATIONALE:Trivalent Influenza vaccine (TIV) is known to induce diminished functional antibody responses and lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in innate responses which translates into suboptimal Hemagglutination Inhibition Assay (HAI) titers. Therefore, early innate signatures of vaccination should correlate with, and predict the immunogenicity of TIV in the young and elderly.
STUDY DESIGN: Single center, open label study in which adult healthy volunteers with no contraindications to immunization will be vaccinated with TIV. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30, D180 post vaccination to study innate and/or adaptive immunity markers. Even though influenza vaccination is considered safe, volunteers will be asked to report any local or systemic adverse events (AEs) from Day 0 (vaccination) to Day 7 in memory aids. Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Volunteers will be also asked to report local and systemic AEs developing the day of a blood draw.
Additionally, only AEs considered related (unlikely, possibly, probably or definitely related) will be collected and reported in this study from Day 0 (vaccination) to Day 180. After Day 30 only related SAEs will be collected and reported.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 25-40 | Other | Biological: trivalent Influenza vaccine (TIV)Trivalent Influenza vaccine given to age 25-40 |
| Age ≥65 | Other | Biological: trivalent Influenza vaccine (TIV)Trivalent Influenza vaccine given to age≥65 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals aged 25-40 years, or ≥65 years old.
- Able to understand and give informed consent.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after trivalent Influenza vaccination.
Key exclusion criteria (21 listed)
- Receipt of immune products:
- Documented influenza infection during the 2010-2011 influenza season. Not excluded from the study, volunteers with prior upper respiratory infections during the 2010-2011 influenza illness.
- Presence of co-morbidities or immunosuppressive states such as:
- Conditions that could affect the safety of the volunteers such as:
- Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0C], regardless of the route) within 3 days prior to study entry *.
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 |
|---|---|---|
| trivalent Influenza vaccine (TIV)Also: Fluzone0.5 ml IM as a single dose in a prefilled syringe. | Biological | Age 25-40, Age ≥65 |
Primary outcome
Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures
Time frame: Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)
The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.
1 secondary outcome
Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nadine Rouphael, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trivalent Influenza vaccine (TIV) in people with Influenza, run by Emory University at 1 site in United States.
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 3 inclusion and 21 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 30 Nov 2015. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures (time frame: Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)). 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 30 Nov 2015.