InfluenzaPhase 4NCT00396305
Th1 Response to Influenza: Aging and Vaccine Efficacy
A Phase 4 study testing Trivalent Inactivated Influenza in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This research study is being done because influenza (flu) affects many people each year throughout the world. The elderly and those with chronic health problems are at greater risk for complications from the flu. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent Inactivated Influenza
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jan 2008
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females 21 to 40 years of age or between 60 and 89, or 90 years or older at the time of enrollment.
- Subjects must provide written informed consent prior to first study intervention.
- Subject is judged to be healthy on the basis of verbal history and physical examination.
- Subject is able to cooperate with the requirements of the study (must be able to complete the diary cards and will be available for 6 months after enrollment).
- Subject is mentally capable to give consent based on investigator judgment.
- Females of childbearing potential (all women under the age of 40) must agree to use medically approved contraception and must agree to continue using this method for at least three months after enrollment. Females of childbearing potential on hormonal contraception must be stable on hormonal contraception and must agree to use this method of contraception for at least three months after enrollment. Acceptable forms of medically approved contraception include the use of: oral contraceptives, injectable contraceptives (i.e., Depo-Provera), transdermal contraceptives or double barrier method.
- All females 40 years of age and under must have a negative urine pregnancy test prior to any vaccination in this trial. Please note that even those participants that have a history of tubal ligation or hysterectomy or are post menopausal (at least one year of no menses) must still have a negative urine pregnancy test prior to any vaccination in this trial.
- Physical examination must be normal, or abnormal findings must be judged not clinically significant for this patient population by the Physician Investigator.
Who cannot join
- Had physician-diagnosed influenza at any time during the past two years.
- Received an influenza vaccine 6 months preceding enrollment in the study.
- Received any other vaccine within 30 days before starting this study or plan to receive any vaccine during the 30 days after enrollment.
- Received immunoglobulin therapy or transfusion with blood or blood products within the previous three months.
- Have known chemical dependency liable to compromise immune function (e.g., alcoholism or illegal drug use not including nicotine or caffeine).
- Are allergic to eggs or egg products, contact lens solution, or have ever had a severe reaction to any vaccine.
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- Have a history of hypersensitivity (allergy) to thimerosal or formaldehyde.
- Have chronic respiratory illnesses (clinically significant and/or on systemic immunosuppressive medications e.g., asthma, COPD, emphysema).
- Have had symptoms of an active acute respiratory or other active infections or illnesses in the past 72 hours.
- Have a temperature greater than or equal to 100.4 degrees F (38 degrees C) at enrollment.
- Known or suspected diseases of the immune system (i.e., rheumatoid arthritis, lupus erythematosis, lymphoma, HIV, etc.).
- Have active neurologic disorders (i.e., encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy).
- Prior history of Guillain-Barré Syndrome.
- Have underlying unstable (require frequent physician office visits, have required a medication change in the past 3 months and/or require frequent medication dose changes) chronic disease such as cardiovascular disease (i.e., uncontrolled hypertension, congestive heart failure, recent heart attack (within past 6 months), cardiomyopathy; diabetes mellitus, liver disease (i.e., hepatitis, cirrhosis), functional or anatomic asplenia, cancer (excluding skin and prostate cancer) or kidney disease.
- Have a history of hematologic malignancy.
- Current treatment with an immunosuppressive medication (i.e., cancer therapeutic agents, corticosteroids, excluding topical and inhaled corticosteroids).
- Pregnant or breastfeeding females or females planning to become pregnant in the next 6 months.
- Have a latex allergy.
- Are participating in another clinical research trial within 30 days of starting this trial or planning to participate in another clinical research trial at any time during this trial.
- Have any condition that would, in the opinion of the investigator, place subject at risk of injury or render subject unable to meet study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
This research study is being done because influenza (flu) affects many people each year throughout the world. The elderly and those with chronic health problems are at greater risk for complications from the flu. The purpose of this research study is to evaluate vaccination strategies in the elderly and others receiving the influenza vaccination in order to increase protection. All subjects will receive the flu vaccine as an injection in the muscle of the upper arm. Participants may receive a booster [an extra dose of vaccine or placebo (inactive substance)] shot. Study participants will include healthy adult volunteers, ages 21-40, 60-89, or 90 years and older. Subjects will be involved in study related procedures for 6 months.
Read the detailed description
Influenza and pneumonia are the fourth leading cause of death among people aged over 65 years. Influenza also leads as a cause of catastrophic disability, greatly affecting the quality of life of elderly persons. In the United States alone, an estimated 10 billion dollars is spent annually due to the impact of influenza, and this will rise as the population of seniors rapidly expands. Thus, influenza vaccination is recommended for elderly adults. Although it is cost-effective, influenza vaccination only prevents infection in 30 percent-40 percent of those aged over 65, compared to 70 percent-90 percent of those under 65. Reduced influenza vaccine efficacy and greater morbidity and mortality are thought to be largely due to immune senescence, but the underlying mechanism remains poorly understood. A better understanding of immune senescence can ultimately translate into improved effectiveness for a variety of vaccines, including vaccines against bioterrorist attack (such as small pox vaccine), and thereby bring huge advances in disease prevention and billions in cost savings. The commercially available influenza vaccine used in the United States contains inactivated split viral particles of influenza B and two subtypes of influenza A. These vaccines are cost-effective, but far from perfect; up to 61 percent of vaccinated elderly people acquire influenza infection nonetheless. The safety and cost effectiveness of the licensed split influenza virus vaccine is established, reducing researchers' incentive to further improve the vaccine or define the difficult and expensive-to-measure T cell-mediated immunity to it. The ultimate goal of this proposed non-randomized, open-label study is to improve vaccine efficacy in order to reduce morbidity and mortality from influenza and other infectious diseases in elderly people. The primary objective is to examine the safety and immunogenicity of vaccine strategies to enhance the Type 1 Helper Cells (Th1) response by booster at the peak of Influenza specific (IS)-Th1 expansion following first vaccination. The frequency of IS-Th1 and the antibody level on days 7 and 28 will be used as the two main indicators of immunogenicity, although CD8+ T cell response will also be analyzed. The safety profile to be assessed includes immediate adverse events, solicited local and systemic events, and unsolicited adverse events. Seventy-four healthy individuals who are living independently in the communities surrounding the study site will be invited to participate in the trial. Participants between the ages of 21 and 40 years (young cohort) and those 60 years and older (elderly cohort) will be recruited. Participants will be considered active in the trial for 3 months post vaccination. A telephone follow-up visit will be scheduled at 6 months post-vaccination. Four groups of subjects will be recruited: 1 control group (Group 1) and 3 experimental groups (Group 2, Group 3, and Group 4). This study is linked to DMID protocol 05-0125. Protocol 05-0125 contains Part II of this study.
- Conditions
- Influenza
- Being tested
- Placebo, Trivalent Inactivated Influenza
- Keywords
- Influenza, vaccine, efficacy, 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.
PlaceboDrug
Sterile phosphate buffered saline solution.
Trivalent Inactivated InfluenzaBiological
The trivalent influenza vaccine is a sterile suspension prepared from the allantoic fluids of chicken embryos infected with a specific type of influenza virus. Each 0.5 mL dose of the vaccine contains 15 mcg hemagglutinin (HA) of 3 strains of virus (H1N1, H3N2, and B). The vaccine is a liquid preparation; as such, no diluent is required. It is essentially clear and slightly opalescent in color.
| Study group | Role | What they receive |
|---|---|---|
| Group 2, Control Double Dose | Experimental | 12 elderly and 6 young participants. This group will be vaccinated with a double dose of vaccine without booster on Day 0. These subjects will receive a double-dose of vaccine administered as 2 consecutive injections (2 injections of 0.5 mL) in the same deltoid. The control group for Group 2 is group 1, Cohort 2. Receives: Biological: Trivalent Inactivated Influenza |
| Group 3-Control late booster | Experimental | 12 elderly and 6 young participants. This group will be vaccinated with the standard dose of vaccine (0.5 mL) on Day 0 and with a booster dose of vaccine (0.5 mL) on Day 21. The control for Group 3 is Group 1, Cohort 3. Receives: Biological: Trivalent Inactivated Influenza |
| Group 1, Control | Active comparator | 12 elderly and 8 young participants. Group 1 will be further divided into 4 equal cohorts (each containing 3 elderly and 2 young adults). Cohorts 2, 3, and 4 will receive the standard dose of vaccine and placebo (0.5 mL saline) on Day 0, 21, or 7 respectively. Cohort 1 will be vaccinated with the standard dose of vaccine without placebo/vaccine booster. Receives: Drug: Placebo |
| Group 4-Control early booster | Experimental | 12 elderly and 6 young participants. This group will be vaccinated with the standard dose of vaccine (0.5 mL) on Day 0 and with a booster dose of vaccine (0.5 mL) on Day 7. The control for Group 4 is Group 1, Cohort 4. Receives: Biological: Trivalent Inactivated Influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: measured by frequency of IS-Th1 and antibody and T cell responses.
Measured: Days 7, 28, 56, and 84 following the initial vaccination.
Safety: including rates of serious adverse events (SAEs) and their relationship to vaccination; rates of local or systemic solicited adverse events (AEs) and their categories; and reported unsolicited AEs following vaccination.
Measured: Safety evaluation at 4, 14, and 28 days post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396305
- Sponsor's protocol ID
- 05-0070
- Status last verified
- May 2010
- First submitted
- 2 Nov 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Th1 Response to Influenza: Aging and Vaccine Efficacy
- ClinicalTrials.gov ID
- NCT00396305
- Acronym / sponsor ID
- 05-0070
- Conditions
- Influenza
- Keywords
- Influenza, vaccine, efficacy, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 6 Nov 2006 (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.
This research study is being done because influenza (flu) affects many people each year throughout the world. The elderly and those with chronic health problems are at greater risk for complications from the flu. The purpose of this research study is to evaluate vaccination strategies in the elderly and others receiving the influenza vaccination in order to increase protection. All subjects will receive the flu vaccine as an injection in the muscle of the upper arm. Participants may receive a booster [an extra dose of vaccine or placebo (inactive substance)] shot. Study participants will include healthy adult volunteers, ages 21-40, 60-89, or 90 years and older. Subjects will be involved in study related procedures for 6 months.
Detailed description
Influenza and pneumonia are the fourth leading cause of death among people aged over 65 years. Influenza also leads as a cause of catastrophic disability, greatly affecting the quality of life of elderly persons. In the United States alone, an estimated 10 billion dollars is spent annually due to the impact of influenza, and this will rise as the population of seniors rapidly expands. Thus, influenza vaccination is recommended for elderly adults. Although it is cost-effective, influenza vaccination only prevents infection in 30 percent-40 percent of those aged over 65, compared to 70 percent-90 percent of those under 65. Reduced influenza vaccine efficacy and greater morbidity and mortality are thought to be largely due to immune senescence, but the underlying mechanism remains poorly understood. A better understanding of immune senescence can ultimately translate into improved effectiveness for a variety of vaccines, including vaccines against bioterrorist attack (such as small pox vaccine), and thereby bring huge advances in disease prevention and billions in cost savings. The commercially available influenza vaccine used in the United States contains inactivated split viral particles of influenza B and two subtypes of influenza A. These vaccines are cost-effective, but far from perfect; up to 61 percent of vaccinated elderly people acquire influenza infection nonetheless. The safety and cost effectiveness of the licensed split influenza virus vaccine is established, reducing researchers' incentive to further improve the vaccine or define the difficult and expensive-to-measure T cell-mediated immunity to it. The ultimate goal of this proposed non-randomized, open-label study is to improve vaccine efficacy in order to reduce morbidity and mortality from influenza and other infectious diseases in elderly people. The primary objective is to examine the safety and immunogenicity of vaccine strategies to enhance the Type 1 Helper Cells (Th1) response by booster at the peak of Influenza specific (IS)-Th1 expansion following first vaccination. The frequency of IS-Th1 and the antibody level on days 7 and 28 will be used as the two main indicators of immunogenicity, although CD8+ T cell response will also be analyzed. The safety profile to be assessed includes immediate adverse events, solicited local and systemic events, and unsolicited adverse events. Seventy-four healthy individuals who are living independently in the communities surrounding the study site will be invited to participate in the trial. Participants between the ages of 21 and 40 years (young cohort) and those 60 years and older (elderly cohort) will be recruited. Participants will be considered active in the trial for 3 months post vaccination. A telephone follow-up visit will be scheduled at 6 months post-vaccination. Four groups of subjects will be recruited: 1 control group (Group 1) and 3 experimental groups (Group 2, Group 3, and Group 4). This study is linked to DMID protocol 05-0125. Protocol 05-0125 contains Part II of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2, Control Double Dose | Experimental | Biological: Trivalent Inactivated Influenza12 elderly and 6 young participants. This group will be vaccinated with a double dose of vaccine without booster on Day 0. These subjects will receive a double-dose of vaccine administered as 2 consecutive injections (2 injections of 0.5 mL) in the same deltoid. The control group for Group 2 is group 1, Cohort 2. |
| Group 3-Control late booster | Experimental | Biological: Trivalent Inactivated Influenza12 elderly and 6 young participants. This group will be vaccinated with the standard dose of vaccine (0.5 mL) on Day 0 and with a booster dose of vaccine (0.5 mL) on Day 21. The control for Group 3 is Group 1, Cohort 3. |
| Group 1, Control | Active comparator | Drug: Placebo12 elderly and 8 young participants. Group 1 will be further divided into 4 equal cohorts (each containing 3 elderly and 2 young adults). Cohorts 2, 3, and 4 will receive the standard dose of vaccine and placebo (0.5 mL saline) on Day 0, 21, or 7 respectively. Cohort 1 will be vaccinated with the standard dose of vaccine without placebo/vaccine booster. |
| Group 4-Control early booster | Experimental | Biological: Trivalent Inactivated Influenza12 elderly and 6 young participants. This group will be vaccinated with the standard dose of vaccine (0.5 mL) on Day 0 and with a booster dose of vaccine (0.5 mL) on Day 7. The control for Group 4 is Group 1, Cohort 4. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy males and females 21 to 40 years of age or between 60 and 89, or 90 years or older at the time of enrollment.
- Subjects must provide written informed consent prior to first study intervention.
- Subject is judged to be healthy on the basis of verbal history and physical examination.
- Subject is able to cooperate with the requirements of the study (must be able to complete the diary cards and will be available for 6 months after enrollment).
- Subject is mentally capable to give consent based on investigator judgment.
Key exclusion criteria (20 listed)
- Had physician-diagnosed influenza at any time during the past two years.
- Received an influenza vaccine 6 months preceding enrollment in the study.
- Received any other vaccine within 30 days before starting this study or plan to receive any vaccine during the 30 days after enrollment.
- Received immunoglobulin therapy or transfusion with blood or blood products within the previous three months.
- Have known chemical dependency liable to compromise immune function (e.g., alcoholism or illegal drug use not including nicotine or caffeine).
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 |
|---|---|---|
| PlaceboSterile phosphate buffered saline solution. | Drug | Group 1, Control |
| Trivalent Inactivated InfluenzaThe trivalent influenza vaccine is a sterile suspension prepared from the allantoic fluids of chicken embryos infected with a specific type of influenza virus. Each 0.5 mL dose of the vaccine contains 15 mcg hemagglutinin (HA) of 3 strains of virus (H1N1, H3N2, and B). The vaccine is a liquid preparation; as such, no diluent is required. It is essentially clear and slightly opalescent in color. | Biological | Group 2, Control Double Dose, Group 3-Control late booster, Group 4-Control early booster |
Primary outcome
Immunogenicity: measured by frequency of IS-Th1 and antibody and T cell responses.
Time frame: Days 7, 28, 56, and 84 following the initial vaccination.
Safety: including rates of serious adverse events (SAEs) and their relationship to vaccination; rates of local or systemic solicited adverse events (AEs) and their categories; and reported unsolicited AEs following vaccination.
Time frame: Safety evaluation at 4, 14, and 28 days post-vaccination.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trivalent Inactivated Influenza in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 27 Aug 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Immunogenicity: measured by frequency of IS-Th1 and antibody and T cell responses. (time frame: Days 7, 28, 56, and 84 following the initial vaccination.). The study lists 2 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 27 Aug 2010.