InfluenzaPhase 1NCT00380237
Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B)
A Phase 1 study testing H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in people with Influenza and Virus Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Avian influenza (AI), also known as bird flu, has become a major public health concern in many regions of the world. The purpose of this study is to evaluate the safety of and immune response to an AI vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Virus Diseases
- What is being tested?
- H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Born after 1968
- Good general health
- Available for the duration of the study
- Female participants must agree to use acceptable forms of contraception
Who cannot join
- Significant medical illness, physical examination findings, or urine or blood abnormalities
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
- Previously enrolled in an H9N2 influenza vaccine study or in any other study of a bird flu vaccine
- Positive for the H9N2 influenza A virus (serum hemagglutination inhibiting [HI] factor antibody titer greater than 1:8)
- Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
Show all 28Show fewer
- History of severe allergic reaction or anaphylaxis
- Current asthma or reactive airway disease within 2 years prior to study entry
- History of Guillain-Barre syndrome
- HIV-1 serotype positive
- Hepatitis C virus (HCV) positive
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical corticosteroids are not excluded.
- Live vaccine within 4 weeks prior to study entry
- Killed vaccine within 2 weeks prior to study entry
- Absence of spleen
- Blood products within 6 months prior to study entry
- Current smoker unwilling to stop smoking for the duration of the study
- Plans to travel to the Southern Hemisphere or Asia within 14 days prior to study entry
- Plans to travel on a cruise ship within 14 days prior to study entry
- Work in the poultry industry
- Received an investigational agent within 30 days prior to study entry
- Allergy to eggs or egg products
- Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
- Family member with immunodeficiency
- Other condition that, in the opinion of the investigator, would affect participation in the study
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research Inpatient Unit, Mason F. Lord Building, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Phase 1 Inpatient Study of the Safety and Immunogenicity of H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in the Event of a Pandemic (Study B)
Avian influenza (AI), also known as bird flu, has become a major public health concern in many regions of the world. The purpose of this study is to evaluate the safety of and immune response to an AI vaccine in healthy adults.
Read the detailed description
AI is caused by a virus that occurs naturally among birds. Because the virus has the ability to mutate into a form that can efficiently spread among the human population, AI has the potential to cause pandemics. The purpose of this study is to evaluate the safety of and immune response to the AI vaccine H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in healthy adults who have never been exposed to the H9N2 virus.
This study will last from approximately 6 weeks, up to a maximum of approximately 20 weeks. Participation includes a 10-day minimum hospital stay in an isolation unit of the Bayview Medical Center of Johns Hopkins University. Participants will be admitted to the isolation unit 2 days prior to vaccination. At vaccination, participants will be given one dose of the H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine in the form of nose drops. Each day for the next 7 days, participants' vital signs will be monitored and nasal washes will be collected to test for the presence of vaccine virus. Participants may be discharged from the hospital after 3 consecutive negative viral cultures, but not before Day 7 after vaccination. Follow-up visits will occur on Days 21, 28, and 42, and will include blood collection and a physical exam.
Participants who received the first dose of the (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine will be asked to receive a second dose of the vaccine 4 to 12 weeks after receiving the initial dose. Study procedures will be identical to those related to the first vaccination.
- Conditions
- Influenza, Virus Diseases
- Being tested
- H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)
- Keywords
- Bird Flu, Avian Flu
- Medical subject headings
- Influenza, Human, Virus Diseases, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)Biological
Live attenuated H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Two vaccinations with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. The second vaccination will be given 4 to 12 weeks after the first. Receives: Biological: H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose
Measured: Throughout study
Immunogenicity, as determined by antibody to H9N2
Measured: At Days 0, 28, and 42
Determining the amount of serum and nasal wash antibody induced by the vaccine
Measured: Throughout study
Secondary outcomes (4)
To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate
Measured: Throughout study
To determine the phenotypic stability of vaccine virus shed
Measured: Throughout study
To develop a serum bank so that the capacity of the H9N2 G9/AA ca reassortant vaccine candidate to elicit HI and neutralizing antibodies to future H9N2 influenza viruses can be tested
Measured: Throughout study
To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Investigators
- Ruth A. Karron, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380237
- Sponsor's protocol ID
- CIR 211 (Study B)
- Other IDs
- CHR H.22.05.03.11.B2
- Status last verified
- Jan 2008
- First submitted
- 22 Sep 2006
- Last updated
- 21 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi YK, Ozaki H, Webby RJ, Webster RG, Peiris JS, Poon L, Butt C, Leung YH, Guan Y. Continuing evolution of H9N2 influenza viruses in Southeastern China. J Virol. 2004 Aug;78(16):8609-14. doi: 10.1128/JVI.78.16.8609-8614.2004.
PubMed 15280470Cox NJ, Subbarao K. Global epidemiology of influenza: past and present. Annu Rev Med. 2000;51:407-21. doi: 10.1146/annurev.med.51.1.407.
PubMed 10774473Li C, Yu K, Tian G, Yu D, Liu L, Jing B, Ping J, Chen H. Evolution of H9N2 influenza viruses from domestic poultry in Mainland China. Virology. 2005 Sep 15;340(1):70-83. doi: 10.1016/j.virol.2005.06.025.
PubMed 16026813Lin YP, Shaw M, Gregory V, Cameron K, Lim W, Klimov A, Subbarao K, Guan Y, Krauss S, Shortridge K, Webster R, Cox N, Hay A. Avian-to-human transmission of H9N2 subtype influenza A viruses: relationship between H9N2 and H5N1 human isolates. Proc Natl Acad Sci U S A. 2000 Aug 15;97(17):9654-8. doi: 10.1073/pnas.160270697.
PubMed 10920197
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Inpatient Study of the Safety and Immunogenicity of H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in the Event of a Pandemic (Study B)
- ClinicalTrials.gov ID
- NCT00380237
- Acronym / sponsor ID
- CIR 211 (Study B)
- Conditions
- Influenza, Virus Diseases
- Keywords
- Bird Flu, Avian Flu
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Study start
- Oct 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 25 Sep 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.
Avian influenza (AI), also known as bird flu, has become a major public health concern in many regions of the world. The purpose of this study is to evaluate the safety of and immune response to an AI vaccine in healthy adults.
Detailed description
AI is caused by a virus that occurs naturally among birds. Because the virus has the ability to mutate into a form that can efficiently spread among the human population, AI has the potential to cause pandemics. The purpose of this study is to evaluate the safety of and immune response to the AI vaccine H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in healthy adults who have never been exposed to the H9N2 virus.
This study will last from approximately 6 weeks, up to a maximum of approximately 20 weeks. Participation includes a 10-day minimum hospital stay in an isolation unit of the Bayview Medical Center of Johns Hopkins University. Participants will be admitted to the isolation unit 2 days prior to vaccination. At vaccination, participants will be given one dose of the H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine in the form of nose drops. Each day for the next 7 days, participants' vital signs will be monitored and nasal washes will be collected to test for the presence of vaccine virus. Participants may be discharged from the hospital after 3 consecutive negative viral cultures, but not before Day 7 after vaccination. Follow-up visits will occur on Days 21, 28, and 42, and will include blood collection and a physical exam.
Participants who received the first dose of the (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine will be asked to receive a second dose of the vaccine 4 to 12 weeks after receiving the initial dose. Study procedures will be identical to those related to the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)Two vaccinations with H9N2 (6-2) AA ca Reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine at a dose of 10^7 TCID50 delivered by nose drops. The second vaccination will be given 4 to 12 weeks after the first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Born after 1968
- Good general health
- Available for the duration of the study
- Female participants must agree to use acceptable forms of contraception
Key exclusion criteria (28 listed)
- Significant medical illness, physical examination findings, or urine or blood abnormalities
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
- Previously enrolled in an H9N2 influenza vaccine study or in any other study of a bird flu vaccine
- Positive for the H9N2 influenza A virus (serum hemagglutination inhibiting [HI] factor antibody titer greater than 1:8)
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 |
|---|---|---|
| H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca)Live attenuated H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) vaccine | Biological | 1 |
Primary outcome
Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose
Time frame: Throughout study
Immunogenicity, as determined by antibody to H9N2
Time frame: At Days 0, 28, and 42
Determining the amount of serum and nasal wash antibody induced by the vaccine
Time frame: Throughout study
4 secondary outcomes
To determine the number of vaccinees infected with the H9N2 G9/AA ca reassortant vaccine candidate
Time frame: Throughout study
To determine the phenotypic stability of vaccine virus shed
Time frame: Throughout study
To develop a serum bank so that the capacity of the H9N2 G9/AA ca reassortant vaccine candidate to elicit HI and neutralizing antibodies to future H9N2 influenza viruses can be tested
Time frame: Throughout study
To evaluate T-cell mediated and innate immune responses against the H9N2 G9/AA ca reassortant vaccine candidate
Time frame: Throughout study
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 21 Jan 2008.
- Background: PubMed 15280470Choi YK, Ozaki H, Webby RJ, Webster RG, Peiris JS, Poon L, Butt C, Leung YH, Guan Y. Continuing evolution of H9N2 influenza viruses in Southeastern China. J Virol. 2004 Aug;78(16):8609-14. doi: 10.1128/JVI.78.16.8609-8614.2004.
- Background: PubMed 10774473Cox NJ, Subbarao K. Global epidemiology of influenza: past and present. Annu Rev Med. 2000;51:407-21. doi: 10.1146/annurev.med.51.1.407.
- Background: PubMed 16026813Li C, Yu K, Tian G, Yu D, Liu L, Jing B, Ping J, Chen H. Evolution of H9N2 influenza viruses from domestic poultry in Mainland China. Virology. 2005 Sep 15;340(1):70-83. doi: 10.1016/j.virol.2005.06.025.
- Background: PubMed 10920197Lin YP, Shaw M, Gregory V, Cameron K, Lim W, Klimov A, Subbarao K, Guan Y, Krauss S, Shortridge K, Webster R, Cox N, Hay A. Avian-to-human transmission of H9N2 subtype influenza A viruses: relationship between H9N2 and H5N1 human isolates. Proc Natl Acad Sci U S A. 2000 Aug 15;97(17):9654-8. doi: 10.1073/pnas.160270697.
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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.
Ruth A. Karron, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H9N2 (6-2) AA ca Reassortant (A/Chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca) in people with Influenza and Virus Diseases, 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 4 inclusion and 28 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 21 Jan 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as defined by frequency of vaccine-related reactogenicity events and other adverse events (AEs) for each dose (time frame: Throughout study). 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?
On the ClinicalTrials.gov record for NCT00380237, which also lists 4 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 21 Jan 2008.