InfluenzaPhase 1/2NCT00230750
Inactivated Influenza A/H5N1 Vaccine in the Elderly
A Phase 1/2 study testing Influenza A/H5N1 Vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza A/H5N1 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2005to Jan 2007
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ambulatory adult aged 65 and older.
- Is in good health, as determined by vital signs (heart rate <100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg] oral temperature < 100 degrees F), medical history to ensure stable medical condition, and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
Who cannot join
- Has a known allergy to eggs or other components of the vaccine or sensitivity to latex.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- Is using oral or parenteral steroids, high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
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- Has a history of alcohol abuse or drug abuse (including chronic pain medication) in the last 5 years.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long as there has been no dose adjustment within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
- Has a history of severe reactions following immunization with influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.0 degrees F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 14-month study period.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Has any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia.
- Has known Latex allergy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Vanderbilt University
Nashville, Tennessee, 37232-2573
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001
UCLA Center For Vaccine Research
Torrance, California, 90502
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Elderly Adults
The purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and older. The vaccine is given as an injection or shot in the arm. Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine. Study procedures will include physical exams and blood sample collections. Additionally, participants will complete a memory aid card to document daily temperatures and any symptoms experienced for a week after receiving vaccine. The length of participation in this study will be approximately 14 months.
Read the detailed description
The goals of this study are to compare the safety, reactogenicity, and immunogenicity of two dose levels of monovalent subvirion influenza A/H5N1 virus vaccine administered by injection to healthy elderly adults aged 65 years and older. Researchers hypothesize that a dose of either 45 micrograms or 90 micrograms of H5N1 vaccine will be well tolerated and result in acceptable immunogenicity. Thus, the primary goal of this study is to determine the lowest dose level of H5N1 that will result in an acceptable proportion of subjects achieving a potentially protective postvaccination antibody titer combined with an acceptable safety profile. The study will enroll at least 240 (and up to 260) healthy ambulatory male and female subjects aged 65 and older, in the United States, may be enrolled. Three doses of the vaccine at 2 dose levels (45 micrograms or 90 micrograms) or saline placebo will be administered 28 days apart for the first two doses. The third dose will be given six months after the first dose. Serum hemagglutination inhibition (HAI) and neutralizing antibody titers will be assessed approximately 1 month after receipt of each dose and 6 month after first and third doses. The primary objectives of the study are: to determine the dose-related safety of intramuscular (IM) subvirion inactivated H5N1 vaccine in healthy elderly adults (65 years of age and older); to determine the immunogenicity of IM subvirion inactivated H5N1 vaccine approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dose level(s) for further studies. The secondary objective is to determine the immunogenicity of IM subvirion inactivated H5N1 vaccine approximately 1 and 6 months following receipt of first and third doses of the vaccine. The primary endpoints include: adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments); proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); geometric mean titer (GMT) and the frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56). The secondary endpoints include: development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus and geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) and neutralizing antibody titer 1 and 6 months after receipt of first and third dose of vaccine. The duration of the study will be approximately 15 months (approximately 14 months for each subject). This study is linked to DMID protocols 07-0022 and 05-0006.
- Conditions
- Influenza
- Being tested
- Influenza A/H5N1 Vaccine, Placebo
- Keywords
- influenza, elderly, vaccine, H5N1, parent protocol
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza A/H5N1 VaccineBiological
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 90-mcg/mL. Dosages: 45 mcg or 90 mcg administered intramuscularly.
PlaceboDrug
Saline placebo.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | 100 subjects to receive 90 mcg of inactivated influenza A/H5N1 vaccine on days 0, 28, and 6 months following the 1st vaccination. Receives: Biological: Influenza A/H5N1 Vaccine |
| 3 | Placebo comparator | 40 subjects to receive saline placebo on days 0, 28, and 6 months following the 1st vaccination. Receives: Drug: Placebo |
| 1 | Experimental | 100 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine on days 0, 28, and 6 months following the 1st vaccination. Receives: Biological: Influenza A/H5N1 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) and the frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of vaccine.
Measured: Approximately day 56.
Proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine.
Measured: Approximately day 56.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Measured: Adverse events will be collected for 28 days following each dose of vaccine. Serious adverse events will be collected throughout the study through month 13.
Secondary outcomes (2)
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Measured: Blood samples for serum assays will be collected at day 0 and at days 28, 56, month 6, 7 and 13 after the first immunization.
Geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) and neutralizing antibody titer 1 and 6 months after receipt of first and third dose of vaccine.
Measured: Blood samples for serum assays will be collected at day 0 and at days 28, 56, month 6, 7 and 13 after the first immunization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2007
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230750
- Sponsor's protocol ID
- 04-076
- Status last verified
- Sep 2008
- First submitted
- 29 Sep 2005
- Last updated
- 23 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Elderly Adults
- ClinicalTrials.gov ID
- NCT00230750
- Acronym / sponsor ID
- 04-076
- Conditions
- Influenza
- Keywords
- influenza, elderly, vaccine, H5N1, parent protocol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 3 Oct 2005 (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 purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and older. The vaccine is given as an injection or shot in the arm. Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine. Study procedures will include physical exams and blood sample collections. Additionally, participants will complete a memory aid card to document daily temperatures and any symptoms experienced for a week after receiving vaccine. The length of participation in this study will be approximately 14 months.
Detailed description
The goals of this study are to compare the safety, reactogenicity, and immunogenicity of two dose levels of monovalent subvirion influenza A/H5N1 virus vaccine administered by injection to healthy elderly adults aged 65 years and older. Researchers hypothesize that a dose of either 45 micrograms or 90 micrograms of H5N1 vaccine will be well tolerated and result in acceptable immunogenicity. Thus, the primary goal of this study is to determine the lowest dose level of H5N1 that will result in an acceptable proportion of subjects achieving a potentially protective postvaccination antibody titer combined with an acceptable safety profile. The study will enroll at least 240 (and up to 260) healthy ambulatory male and female subjects aged 65 and older, in the United States, may be enrolled. Three doses of the vaccine at 2 dose levels (45 micrograms or 90 micrograms) or saline placebo will be administered 28 days apart for the first two doses. The third dose will be given six months after the first dose. Serum hemagglutination inhibition (HAI) and neutralizing antibody titers will be assessed approximately 1 month after receipt of each dose and 6 month after first and third doses. The primary objectives of the study are: to determine the dose-related safety of intramuscular (IM) subvirion inactivated H5N1 vaccine in healthy elderly adults (65 years of age and older); to determine the immunogenicity of IM subvirion inactivated H5N1 vaccine approximately 1 month following receipt of 2 doses of vaccine; and to provide information for the selection of the best dose level(s) for further studies. The secondary objective is to determine the immunogenicity of IM subvirion inactivated H5N1 vaccine approximately 1 and 6 months following receipt of first and third doses of the vaccine. The primary endpoints include: adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments); proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); geometric mean titer (GMT) and the frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56). The secondary endpoints include: development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus and geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) and neutralizing antibody titer 1 and 6 months after receipt of first and third dose of vaccine. The duration of the study will be approximately 15 months (approximately 14 months for each subject). This study is linked to DMID protocols 07-0022 and 05-0006.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Biological: Influenza A/H5N1 Vaccine100 subjects to receive 90 mcg of inactivated influenza A/H5N1 vaccine on days 0, 28, and 6 months following the 1st vaccination. |
| 3 | Placebo comparator | Drug: Placebo40 subjects to receive saline placebo on days 0, 28, and 6 months following the 1st vaccination. |
| 1 | Experimental | Biological: Influenza A/H5N1 Vaccine100 subjects to receive 45 mcg of inactivated influenza A/H5N1 vaccine on days 0, 28, and 6 months following the 1st vaccination. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Ambulatory adult aged 65 and older.
- Is in good health, as determined by vital signs (heart rate <100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg] oral temperature < 100 degrees F), medical history to ensure stable medical condition, and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
Key exclusion criteria (14 listed)
- Has a known allergy to eggs or other components of the vaccine or sensitivity to latex.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- Is using oral or parenteral steroids, high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
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 |
|---|---|---|
| Influenza A/H5N1 VaccineMonovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 90-mcg/mL. Dosages: 45 mcg or 90 mcg administered intramuscularly. | Biological | 1, 2 |
| PlaceboSaline placebo. | Drug | 3 |
Primary outcome
Geometric mean titer (GMT) and the frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of vaccine.
Time frame: Approximately day 56.
Proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine.
Time frame: Approximately day 56.
Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments).
Time frame: Adverse events will be collected for 28 days following each dose of vaccine. Serious adverse events will be collected throughout the study through month 13.
2 secondary outcomes
Development of serum antibody responses against antigenically drifted variants of H5N1 influenza virus.
Time frame: Blood samples for serum assays will be collected at day 0 and at days 28, 56, month 6, 7 and 13 after the first immunization.
Geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) and neutralizing antibody titer 1 and 6 months after receipt of first and third dose of vaccine.
Time frame: Blood samples for serum assays will be collected at day 0 and at days 28, 56, month 6, 7 and 13 after the first immunization.
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 23 Aug 2013.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Influenza A/H5N1 Vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites 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 4 inclusion and 14 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 23 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 4 sites 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. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Geometric mean titer (GMT) and the frequency of 4-fold or greater increases in neutralizing antibody titers 28 days after receipt of second dose of vaccine. (time frame: Approximately day 56.). 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 23 Aug 2013.