Infectious DiseasesPhase 2NCT00383071
Development of Immune Globulin Treatment for Avian Flu
A Phase 2 study testing H5N1 vaccine and Apheresis in people with Infectious Diseases and Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases, Influenza, Avian Flu
- What is being tested?
- H5N1 vaccine and Apheresis
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2014
- Phase
- Phase 2
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years old, and < 60 years old.
- Adequate clinical parameters (all of the following):
- Afebrile (temperature < 38° C)
- Systolic blood pressure >100 \& <180 mmHg
- Diastolic blood pressure >50 \& <100 mmHg
- Heart rate between 40-100 beats/minute
Show all 14Show fewer
- Weight ≥ 110 pounds (50kg)
- Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
- Females of child-bearing potential must (one of the following):
- Be surgically sterile.
- Be abstinent (or willing to be) 4 weeks prior to date of screening evaluation through the last apheresis session (estimate 6 months).
- Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches, and have been using these for 3 months prior to date of screening evaluation through the last apheresis session (estimate 6 months).
- Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (estimate 6 months).
- Use (by ensuring her male partner(s) uses) barrier contraception (condom) with a spermicide as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (estimate 6 months).
Who cannot join
- Has a medical history of
- Thrombocytopenia or other blood dyscrasias
- congestive heart failure
- pulmonary hypertension
- bleeding diathesis or therapeutic anticoagulation
- HIV/AIDS
Show all 73Show fewer
- Hepatitis B
- Hepatitis C
- Known history of hepatitis after the 11th birthday.
- Trypanosomiasis (Chagas' disease and sleeping sickness)
- Leishmaniasis (Kala-azar)
- Filariasis
- Q fever
- Yaws
- Allergy to eggs, thimerosal, or other components of the vaccine
- Severe reactions following immunization with contemporary influenza virus vaccines
- Autoimmune disease or a history of Guillain-Barré
- History of cancer that meets any one of the following criteria:
- Non-melanoma skin cancers within the last 1 year
- Melanoma or any other cancer (excluding non-melanoma skin cancers) at any time
- Medication history that includes any of the following:
- Current use of oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs
- Finasteride (Proscar, Propecia) within the last 1 month.
- Isotretinoin (Accutane) within the last 1 month.
- Acitretin (Soriatane) within the last 3 years.
- Etretinate (Tegison) at any time.
- Dutasteride (Avodart) within the last 6 months.
- Growth hormone made from human pituitary glands at any time.
- Beef insulin from the United Kingdom at any time.
- Has ever had any of the following:
- Sexual contact with someone known to have HIV.
- Had a relative with Creutzfeldt-Jakob Disease, or been told that this disease is inherited within the family.
- Received blood transfusion in the United Kingdom.
- History of receiving money, drugs or other payment for sex.
- History of receiving clotting factor concentrates.
- History of a dura mater graft.
- History of babesiosis.
- For male donors, history of sexual contact with another male.
- Used needles to take drugs, steroids, or other medications not prescribed by a physician.
- Was born, lived in, had blood donation in or ever had sexual contact with anyone who lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria after 1977.
- History of living 3 or more months total (need not be consecutive) in the UK from 1980-1996.
- History of living 5 or more years total (need not be consecutive) in Europe since 1980.
- History of living 6 or more months total (need not be consecutive) on a U.S. military base in Europe from 1980-1996 (specifically from 1980 through 1990 in Belgium, the Netherlands, or Germany, and from 1980 through 1996 in Spain, Portugal, Turkey, Italy or Greece).
- Within the last 3 weeks received the seasonal (conventional trivalent) flu vaccine
- Within the last 8 weeks:
- Was vaccinated with the small pox vaccine, or was in close contact with someone who was vaccinated (i.e., close family member).
- Within the last 3 months has:
- Current or previous participation in any other apheresis procedures/protocols (not related to this protocol).
- Within the last 4 months has had:
- A blood donation of a double unit of red cells.
- Within the last 12 months has:
- Received any blood or blood component.
- Donated blood at a paid donation center (donations at a hospital blood bank do not apply).
- History of unsafe (multiple-use equipment) tattoo, acupuncture, or piercing practices.
- Received an organ transplant.
- Received a bone or skin graft.
- Lived with someone who has any type of hepatitis.
- Traveled to areas with malaria.
- Been incarcerated for more than 72 hours.
- Oral or inhalation use of illegal drugs (i.e. those not prescribed by a physician).
- Had or has been treated (with or without confirmatory diagnosis) for syphilis or gonorrhea
- Within the last 12 months has had sexual contact with (any of the following):
- An individual having viral hepatitis.
- A prostitute or anyone else who takes money or drugs or other payment for sex.
- Anyone who has ever used needles to take drugs, steroids, or anything else not prescribed by their doctor.
- Anyone who has hemophilia or has used clotting factor concentrates.
- For females, a male who has ever had sexual contact with another male.
- Participation in medical research that includes:
- Protocols that are currently ongoing or will start during the duration of this study that require more than 100cc of blood to be given in any 6-week period of time.
- Administration of any unlicensed drug within the last 3 months or during the duration of this study.
- Administration of any unlicensed vaccine within the last 12 months or during the duration of this study.
- Currently pregnant (if known).
- Any condition that, in the opinion of the investigator, would render vaccination unsafe, would interfere with the antibody response or the evaluation of these responses, or would place the subject at increased risk of injury from apheresis.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Vaccine Dose Finding Pilot Study for Development of an Anti-Influenza A (H5N1) Intravenous Hyper-Immune Globulin
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack the influenza virus. This study will use an experimental bird flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar to the regular influenza vaccine and has been studied in more than 450 people. This study will use high doses of the vaccine to generate high antibody levels that can be collected for producing the new treatment.
Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible for this study. Candidates are screened with a medical history and physical examination.
Read more
Participants are given one of three doses of the vaccine, depending on when they enter the study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated, the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV, hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle aches, or others. At the end of the 7 days, they are contacted by study staff to report the symptoms.
In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood test shows moderately high antibody levels. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates the blood cells from the antibodies and protein. The antibodies and protein are collected and the rest of the blood is returned to the body. Subjects are asked to undergo at least three apheresis procedures.
...
Read the detailed description
Avian influenza presents a threat of a future pandemic. Over 200 people have been infected with the influenza A H5N1 virus, and the mortality is near 60 percent. Optimal therapy is not known, and failures of and resistance to currently available anti-virals have been reported.
The primary purpose of this Protocol is to determine the optimal vaccination schedule that creates a pool of hyper immunized individuals with high titer anti-influenza A (H5N1) antibodies. The Protocol will consist of a dose escalation study to determine the optimal vaccination dose and number of vaccinations. There are stopping rules based on the number and severity of adverse events that occur between the doses and between the cohorts. The optimal vaccination schedule that is determined could then be used in a larger population to develop a high titer anti-influenza A (H5N1) intravenous hyper-immune globulin (IVIG).
After all vaccinations have occured, and if an adequate antibody titer is reached in this study population, subjects will begin apheresis. Each subject will be asked to participate in 3 apheresis sessions, but may participate in up to 10 apheresis sessions.
- Conditions
- Infectious Diseases, Influenza, Avian Flu
- Being tested
- H5N1 vaccine, Apheresis
- Keywords
- Apheresis, Avian Flu, Healthy Volunteers, Infectious Diseases, IVIG, Healthy Volunteer, HV
- Medical subject headings
- Communicable Diseases, Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 vaccineBiological
Monovalent subvirion H5N1 vaccine (rgA/Vietnam/1203/2004) 90 mcg/mL Manufactured by Sanofi Pasteur Inc, Swiftwater, PA.
ApheresisProcedure or surgery
Once subjects achieved a high antibody titer (>1:160), they could begin apheresis to collect plasma.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | H5N1 vaccine - 90 mcg IM every 4 week x 4 doses Apheresis - if HAI titer above 1:160 Receives: Biological: H5N1 vaccine; Procedure: Apheresis |
| Cohort 2 | Active comparator | H5N1 vaccine - 120 mcg IM every 4 week x 4 doses Apheresis - if HAI titer above 1:160 Receives: Biological: H5N1 vaccine; Procedure: Apheresis |
| Cohort 3 | Active comparator | H5N1 vaccine - 180 mcg IM every 4 week x 4 doses Apheresis - if HAI titer above 1:160 Receives: Biological: H5N1 vaccine; Procedure: Apheresis |
| Cohort 4 | Active comparator | H5N1 vaccine - 180 mcg IM every 4 weeks x 2 doses, injection site randomized to either deltoid or gluteus Apheresis - if HAI titer above 1:160 Receives: Biological: H5N1 vaccine; Procedure: Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of H5N1 Vaccine as Measured by Adverse Events
The number of subjects experiencing adverse events after receiving H5N1 vaccine
Measured: Day 28, 56, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2010
- Study completionDec 2014
Why it stopped: Cannot get enough plasma to manufacture IVIG for human trials
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies 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 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- H. Clifford Lane, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383071
- Sponsor's protocol ID
- 06-I-0235
- Other IDs
- 060235
- Status last verified
- Apr 2016
- First submitted
- 29 Sep 2006
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
PubMed 8903148de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72. doi: 10.1056/NEJMoa054512.
PubMed 16371632Chotpitayasunondh T, Ungchusak K, Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S, Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S, Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M, Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005 Feb;11(2):201-9. doi: 10.3201/eid1102.041061.
PubMed 15752436Lu H, Khurana S, Verma N, Manischewitz J, King L, Beigel JH, Golding H. A rapid Flp-In system for expression of secreted H5N1 influenza hemagglutinin vaccine immunogen in mammalian cells. PLoS One. 2011 Feb 28;6(2):e17297. doi: 10.1371/journal.pone.0017297.
PubMed 21386997Beigel JH, Voell J, Huang CY, Burbelo PD, Lane HC. Safety and immunogenicity of multiple and higher doses of an inactivated influenza A/H5N1 vaccine. J Infect Dis. 2009 Aug 15;200(4):501-9. doi: 10.1086/599992.
PubMed 19569973
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Vaccine Dose Finding Pilot Study for Development of an Anti-Influenza A (H5N1) Intravenous Hyper-Immune Globulin
- ClinicalTrials.gov ID
- NCT00383071
- Acronym / sponsor ID
- 06-I-0235
- Conditions
- Infectious Diseases, Influenza, Avian Flu
- Keywords
- Apheresis, Avian Flu, Healthy Volunteers, Infectious Diseases, IVIG, Healthy Volunteer, HV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cannot get enough plasma to manufacture IVIG for human trials
- Enrolment
- 126 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack the influenza virus. This study will use an experimental bird flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar to the regular influenza vaccine and has been studied in more than 450 people. This study will use high doses of the vaccine to generate high antibody levels that can be collected for producing the new treatment.
Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible for this study. Candidates are screened with a medical history and physical examination.
Participants are given one of three doses of the vaccine, depending on when they enter the study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated, the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV, hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle aches, or others. At the end of the 7 days, they are contacted by study staff to report the symptoms.
In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood test shows moderately high antibody levels. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates the blood cells from the antibodies and protein. The antibodies and protein are collected and the rest of the blood is returned to the body. Subjects are asked to undergo at least three apheresis procedures.
...
Detailed description
Avian influenza presents a threat of a future pandemic. Over 200 people have been infected with the influenza A H5N1 virus, and the mortality is near 60 percent. Optimal therapy is not known, and failures of and resistance to currently available anti-virals have been reported.
The primary purpose of this Protocol is to determine the optimal vaccination schedule that creates a pool of hyper immunized individuals with high titer anti-influenza A (H5N1) antibodies. The Protocol will consist of a dose escalation study to determine the optimal vaccination dose and number of vaccinations. There are stopping rules based on the number and severity of adverse events that occur between the doses and between the cohorts. The optimal vaccination schedule that is determined could then be used in a larger population to develop a high titer anti-influenza A (H5N1) intravenous hyper-immune globulin (IVIG).
After all vaccinations have occured, and if an adequate antibody titer is reached in this study population, subjects will begin apheresis. Each subject will be asked to participate in 3 apheresis sessions, but may participate in up to 10 apheresis sessions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Biological: H5N1 vaccine, Procedure: ApheresisH5N1 vaccine - 90 mcg IM every 4 week x 4 doses Apheresis - if HAI titer above 1:160 |
| Cohort 2 | Active comparator | Biological: H5N1 vaccine, Procedure: ApheresisH5N1 vaccine - 120 mcg IM every 4 week x 4 doses Apheresis - if HAI titer above 1:160 |
| Cohort 3 | Active comparator | Biological: H5N1 vaccine, Procedure: ApheresisH5N1 vaccine - 180 mcg IM every 4 week x 4 doses Apheresis - if HAI titer above 1:160 |
| Cohort 4 | Active comparator | Biological: H5N1 vaccine, Procedure: ApheresisH5N1 vaccine - 180 mcg IM every 4 weeks x 2 doses, injection site randomized to either deltoid or gluteus Apheresis - if HAI titer above 1:160 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age ≥ 18 years old, and < 60 years old.
- Adequate clinical parameters (all of the following):
- Weight ≥ 110 pounds (50kg)
- Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
- Females of child-bearing potential must (one of the following):
Key exclusion criteria (73 listed)
- Has a medical history of
- History of cancer that meets any one of the following criteria:
- Medication history that includes any of the following:
- Has ever had any of the following:
- Within the last 3 weeks received the seasonal (conventional trivalent) flu vaccine
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 |
|---|---|---|
| H5N1 vaccineMonovalent subvirion H5N1 vaccine (rgA/Vietnam/1203/2004) 90 mcg/mL Manufactured by Sanofi Pasteur Inc, Swiftwater, PA. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| ApheresisOnce subjects achieved a high antibody titer (>1:160), they could begin apheresis to collect plasma. | Procedure or surgery | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety of H5N1 Vaccine as Measured by Adverse Events
Time frame: Day 28, 56, 84
The number of subjects experiencing adverse events after receiving H5N1 vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8903148Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. doi: 10.3201/eid0101.950102.
- Background: PubMed 16371632de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72. doi: 10.1056/NEJMoa054512.
- Background: PubMed 15752436Chotpitayasunondh T, Ungchusak K, Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S, Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S, Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M, Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005 Feb;11(2):201-9. doi: 10.3201/eid1102.041061.
- Derived from this study: PubMed 21386997Lu H, Khurana S, Verma N, Manischewitz J, King L, Beigel JH, Golding H. A rapid Flp-In system for expression of secreted H5N1 influenza hemagglutinin vaccine immunogen in mammalian cells. PLoS One. 2011 Feb 28;6(2):e17297. doi: 10.1371/journal.pone.0017297.
- Derived from this study: PubMed 19569973Beigel JH, Voell J, Huang CY, Burbelo PD, Lane HC. Safety and immunogenicity of multiple and higher doses of an inactivated influenza A/H5N1 vaccine. J Infect Dis. 2009 Aug 15;200(4):501-9. doi: 10.1086/599992.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
H. Clifford Lane, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H5N1 vaccine and Apheresis in people with Infectious Diseases and 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 14 inclusion and 73 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 31 Jul 2018. 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 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?
Yes. Results are posted in the registry (first posted 27 May 2013). 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?
Safety of H5N1 Vaccine as Measured by Adverse Events (time frame: Day 28, 56, 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383071, which also lists 5 linked publications.
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 31 Jul 2018.